Clinical trial NCT05860114
Conditions: Drug Drug Interaction
Keywords: PK Pharmacokinetics Givinostat Givinostat metabolites
Sponsor: Italfarmaco
Start date: 2022-03-21; Completion date: 2022-05-24
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective:

To evaluate the plasma and urine PK of Givinostat following multiple oral doses of Givinostat.

Secondary objective:

To assess the safety and tolerability multiple oral doses of Givinostat.

Detailed description:
This study was planned as a phase I, open-label, 3-part, fixed-sequence, nonrandomized study in healthy male and female subjects. The study (Part 3) aimed at assessing Givinostat and its metabolites (ITF2374, ITF2375, ITF2440 and ITF2563) plasma and urine concentrations and thereof derived pharmacokinetic parameters following single oral dose administration of Givinostat (Day 1) and following multiple oral dose administration of Givinostat (Day 5 to Day 12, with measures reported at Day 13, before single-dose administration). More precisely, Gmean and corresponding 95% CI of Givinostat plasma and urine concentration and Givinostat metabolites plasma concentration versus time profiles following single (Day 1) and multiple-dose (Day 5 to Day 12, with measures reported at Day 13) administration of Givinostat are reported using Linear Scale and Semi-Logarithmic Scale.

Descriptive statistics of Givinostat plasma pharmacokinetic parameters and Givinostat metabolites PK parameters following single-dose administration of Givinostat (Day 1) and following multiple-dose administration of Givinostat (Days 5-12, with measures reported at Day 13) were calculated.

Descriptive statistics of Givinostat and its metabolites urinary excretion profile following single-dose administration of Givinostat (Day 1) and following multiple dose administration of Givinostat (Days 5-12, with measures reported at Day 13) were calculated.

Descriptive statistics of Givinostat and its metabolites cumulative amount of urinary excretion profile following single-dose administration of Givinostat (Day 1) and following multiple-dose administration of Givinostat (Days 5-12, with measures reported at Day 13) were also calculated using linear scales.

Arms: arm 1: On Days 1 and 13, Givinostat 50 mg as oral suspension was administered as a single dose, in the morning. On Days 5-12 Givinostat 50 mg as oral suspension was administered twice-daily, in the morning and in the evening, as a multiple dose.

PK parameters values following:

* single oral dose administration of Givinostat (Day 1) and
* multiple oral dose administration of Givinostat (Day 5 to Day 12, with values reported at Day 13) were assessed and reported.
Interventions: intervention 1: Givinostat
Intervention descriptions: intervention 1: Drug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension

On days 1 and 13 givinostat was administered in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. Moreover the subjects were in a semi-recumbent position and remained semi-recumbent until at least 4 hours post-dose.No fluids were allowed from 1 hour before dosing until 2 hours post-dose. Water was provided ad libitum at all other times.

From Day 5 to Day 12, subjects received givinostat 50 mg as oral suspension, twice a day, in the morning and in the evening.

Protocol documents:
Prot_000.pdf: 















































































































SAP_001.pdf: 
P a g e  1  of 1 4 3  
S T A TI S TI C A L A N A L Y SI S P L A N  
S T U D Y TI T L E:  
A n O pe n -l a bel, Si n gle-ce nter, T hr ee -p art St u d y i n He alt h y S u bjects t o I n vesti g ate t he Effect 
of Gi vi n ost at o n t he P h ar m ac o ki netics of Mi d az ol a m a n d D a bi g atr a n, t he Effect of 
Cl arit hr o m yci n o n t he P h ar m ac o ki netics of Gi vi n ost at a n d t he P h ar m ac o ki netics of Si n gle 
a n d M ulti ple D oses of Gi vi n ost at.  
Pr ot oc ol C o de:  I T F/ 2 3 5 7/ 5 5 
T y pe:  I nter ve nti o nal, P har mac o ki n eti c a n d Dr u g-Dr u g I nteracti o n 
Trial  
E u dra C T N o.:  2 0 2 1 -0 0 5 7 5 6 -1 1  
Versi o n:  1. 0  
Date  of S A P : 2 4 M A R 2 0 2 2  
S u perse des Versi o n:  N o ne  
Date of S u perse de d Versi o n:  N ot a p plic a ble  
S p o ns or:  I T A L F A R M A C O S. p. A 
Via dei L a v orat ori, 5 4  
2 0 0 9 2 Ci nisell o B alsa m o ( MI), It al y  
wit h its re gist ere d offi ce at  
Viale F ul vi o Testi, 3 3 0,  
Mila n ( MI), Ital y  
w w w.italfar ma c o.c o m  
P h o ne: + 3 9 0 2 6 4 4 3 1  
Fa x: + 3 9 0 2 6 4 4 3 4 6  
Cli nic al P har m ac ol o g y U nit:  
 
 
 
 
 
 
  
 
 
 
 
 
C O N FI D E N TI A LI T Y DI S C L AI M E R  
T his d oc u me nt is c o nfi de nti al a n d is a v ail a ble f or re vie w t o i n vesti g at o rs, re g ul at or y b o dies 
a n d st u d y a u dit pers o n nel. N o p art of t his d oc u me nt m a y be use d, p u blis he d, c o pie d or 
ot her wise discl ose d wit h o ut pri or writte n a ut h ori z ati o n fr o m 
 
 or t he S p o ns or of t his st u d y. 
P P D
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St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2  of 1 4 3  
1. 
SI G N A T U R E P A G E
1. 1.   
Cli nic al Rese ar c h U nit  
 
 
 
 
....................................................... 
Si g nat ure  
....................... 
Date  
  
 
 
 
....................................................... 
Si g nat ure  
....................... 
Date  
1. 2.   
S p o ns or’s Re pr ese nt ati ve  
 
Cli nic al R & D Dire ct or  
Italfar ma c o S. p. A. 
....................................................... 
Si g nat ure  
....................... 
Date  
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I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 3 of  1 4 3
2. 
C O N T E N T S  A N D  A B B R E VI A TI O N S
2. 1. 
T a bl e  of  C o nt e nts
1. 
SI G N A T U R E  P A G E ...................................................................................................... 2
1. 1. 
C LI NI C A L R E S E A R C H U NI T ..................................................................................... 2
1. 2. 
S P O N S O R ’S R E P R E S E N T A TI V E ................................................................................ 2
2. 
C O N T E N T S  A N D  A B B R E VI A TI O N S ........................................................................ 3
2. 1. 
T A B L E  O F C O N T E N T S .............................................................................................. 3
2. 2. 
L I S T  O F A B B R E VI A TI O N S ........................................................................................ 5
3. 
I N T R O D U C TI O N .......................................................................................................... 8
4. 
S T U D Y  O B J E C TI V E S .................................................................................................. 8
4. 1. 
P RI M A R Y ................................................................................................................. 8
4. 2. 
S E C O N D A R Y ............................................................................................................ 8
5. 
I N V E S TI G A TI O N A L  P L A N ........................................................................................ 8
5. 1. 
S T U D Y D E SI G N ....................................................................................................... 8
R ati o n al f or  St u d y  D esi g n ............................................................................ 8
5. 2. 
S T U D Y P L A N ........................................................................................................... 9
P art  3  – P h ar m a c o ki n eti cs  of  Gi vi n ost at  a n d its  M et a b olit es  F oll o wi n g  Si n gl e 
a n d  M ulti pl e  Or al  D os es  of  Gi vi n ost at ..................................................................... 9
5. 3. 
N U M B E R  O F P A R TI CI P A N T S  A N D S A M P L E S I Z E E S TI M A TI O N ................................. 9
P art  3 ......................................................................................................... 1 0
5. 4. 
R A N D O MI Z A TI O N .................................................................................................. 1 0
5. 5. 
B LI N DI N G .............................................................................................................. 1 0
6. 
S T U D Y  A S S E S S M E N T S ............................................................................................. 1 0
6. 1. 
S A F E T Y A S S E S S M E N T S ......................................................................................... 1 0
M e di c al  Hist or y ......................................................................................... 1 0
P h ysi c al  E x a mi n ati o n ................................................................................ 1 1
W ei g ht,  H ei g ht  a n d  B o d y  M ass I n d e x ........................................................ 1 1
Vit al  Si g ns .................................................................................................. 1 1
1 2  L e a d  El e ctr o c ar di o gr a m ....................................................................... 1 1
L a b or at or y  S af et y  T ests ............................................................................. 1 1
A d v ers e  E v e nts ........................................................................................... 1 3
Pr e vi o us  a n d  C o n c o mit a nt  M e di c ati o ns .................................................... 1 4
6. 2. 
P H A R M A C O KI N E TI C A S S E S S M E N T S ...................................................................... 1 4
Bl o o d  S a m pli n g f or  P h ar m a c o ki n eti c  Ass ess m e nts ................................... 1 4
Uri n e  S a m pli n g f or  P h ar m a c o ki n eti c  Ass ess m e nts ................................... 1 5
Pl as m a  P h ar m a c o ki n eti c  P ar a m et ers ....................................................... 1 6
Uri n ar y  P h ar m a c o ki n eti c  P ar a m et ers ...................................................... 1 8
7. 
S T U D Y  E N D P OI N T S .................................................................................................. 1 8
7. 1. 
P RI M A R Y ............................................................................................................... 1 8
7. 2. 
S E C O N D A R Y .......................................................................................................... 1 8
8. 
A N A L Y SI S  P O P U L A TI O N S ...................................................................................... 1 9
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St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 4 of  1 4 3
8. 1. 
P A R T 3 .................................................................................................................. 1 9
P art  3  S af et y  A n al ysis  P o p ul ati o n ............................................................. 1 9
P art  3  P h ar m a c o ki n eti c  A n al ysis  P o p ul ati o n ............................................ 1 9
9. 
D A T A  R E VI E W /  T R A N S F O R M A TI O N ................................................................. 2 0
9. 1. 
D A T A M A N A G E M E N T ........................................................................................... 2 0
9. 2. 
A C C E P T A N C E  O F D A T A ......................................................................................... 2 0
9. 3. 
D A T A T R A N S F O R M A TI O N ( C DI S C)...................................................................... 2 0
1 0. 
S T A TI S TI C A L  M E T H O D S ........................................................................................ 2 2
1 0. 1. 
G E N E R A L C O N SI D E R A TI O N S ............................................................................... 2 3
1 0. 2. 
S U BJ E C T S ’ D I S P O SI TI O N ..................................................................................... 2 3
1 0. 3. 
P R O T O C O L D E VI A TI O N S ..................................................................................... 2 3
1 0. 4. 
P L A S M A P H A R M A C O KI N E TI C C O N C E N T R A TI O N S ............................................... 2 3
1 0. 5. 
P L A S M A P H A R M A C O KI N E TI C P A R A M E T E R S ....................................................... 2 4
1 0. 6. 
U RI N A R Y D A T A .................................................................................................. 2 5
1 0. 7. 
U RI N A R Y P H A R M A C O KI N E TI C P A R A M E T E R S ..................................................... 2 5
1 1. 
P R E S E N T A TI O N  O F  R E S U L T S ............................................................................... 2 5
1 1. 1. 
S T A TI S TI C A L O U T P U T S P E CI FI C A TI O N ............................................................... 2 5
1 1. 2. 
P L A N N E D T A B L E S , F I G U R E S, A N D S U BJ E C T D A T A L I S TI N G S............................. 2 6
I n-t e xt  T a bl es  a n d  Fi g ur es....................................................................... 2 6
T a bl es,  Fi g ur es  a n d  Gr a p hs  R ef err e d t o  B ut  N ot I n cl u d e d i n t h e  T e xt ( S e cti o n 
1 4  of  C S R) ............................................................................................................... 3 0
List  of  S u bj e ct  D at a  Listi n gs ( S e cti o n  1 6. 2  of  C S R) ................................ 4 6
1 2. 
R E F E R E N C E S ............................................................................................................. 4 9
1 3. 
A P P E N DI C E S ............................................................................................................... 5 0
A P P E N DI X A. P L A N N E D T A B L E S , F I G U R E S, A N D S U BJ E C T D A T A L I S TI N G S............... 5 0
A. 1. I n-t e xt  T a bl es  a n d  Fi g ur es – F or  C S R  S y n o psis ............................................. 5 0
A. 2. I n-t e xt  T a bl es  a n d  Fi g ur es – F or  C S R  B o d y  T e xt ........................................... 5 8
A. 3. T a bl es,  Fi g ur es  a n d  Gr a p hs  R ef err e d t o  B ut  N ot I n cl u d e d i n t h e  T e xt ( S e cti o n  1 4 
of  C S R) .................................................................................................................... 7 0
A. 4. List  of  S u bj e ct  D at a  Listi n gs ( S e cti o n  1 6. 2  of  C S R) ...................................... 1 0 9
1 4. 
A N N E X E S ................................................................................................................... 1 4 3
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St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5  of 1 4 3  
2. 2.   
List of A b br e vi ati o ns  
α  
T y pe I Err or ( Si g nifica nce Le vel)  
A b  
A nti b o d y  
A Da M   
A nal ysis Data M o del  
A Da MI G   
A nal ysis Data M o del I m ple me ntati o n G ui de 
A D P C   
A nal ysis Data P har ma c o ki netic C o nce ntrati o ns  
A D P P   
A nal ysis Data P har ma c o ki netic Para meters  
A D S L   
S u bje ct -Le vel A nal ysis  
A E   
A d verse E ve nt  
A L P   
Al kali ne P h os p hatase  
A L T   
Ala ni ne A mi n otra nsferase  
A mea n   
Arit h metic  Mea n  
A N O V A   
A nal y sis of Varia nce 
a P T T   
Acti vate d Partial T hr o m b o plasti n Ti me  
A S T   
As partate A mi n otra nsferase  
A T C   
A nat o mic T hera pe utic C he mic al  
A U C   
Area U n der t he C o nc e ntrati o n Vers us  Ti me C ur ve  
A U C 0 -t  
A U C fr o m Ti me Zer o t o Last Sa m pli n g Ti me wit h Q ua ntifia ble C o nc e ntrati o ns  
A U C 0 -∞   
A U C fr o m Ti me Zer o t o I nfi nit y  
A U C 0 -τ,ss  
A U C C orres p o n di n g t o t he D osi n g I nter val, at Ste a d y State  
A U R C 0 -t  
Area U n der t he Uri nar y E xcreti o n Rate C ur ve fr o m Ti me 0 t o t he Last Rate  
% A U C
e xtra p  
Resi d ual Area or Perc e nta ge of E xtra p olate d Part of A U C 0 -∞
B D S   
Basic Data Str uct ure  
B L Q   
Bel o w  t he Li mit of Q ua ntific ati o n  
B MI   
B o d y Mass I n de x  
b p m   
Be ats Per Mi n ute  
C 0 
Pre -d ose C o nce ntrati o n  
CI  
C o nfi de nc e I nter val  
Cl  
T otal B o d y Cle ara nce  
C K   
Cre ati ne Ki nase  
Cl/ F   
T otal B o d y Cle ara nce Affecte d b y t he Bi oa vaila bilit y Fa ct or  
Cl R   
Re nal Cle ara nc e  
Cl R / F  
Re nal Cle ara nc e Affe cte d b y t he Bi oa vaila bilit y Fa ct or  
C last  
Last Q ua ntifia ble C o nce ntrati o n  
C ma x   
Ma xi m u m O bser ve d C o nce ntrati o n  
C ma x,ss   
Ma xi m u m O bser ve d Plas ma C o nc e ntrati o n at Ste a d y State  
Cr C L  
Cre ati ni ne Cle ara nce  
C S P   
Cli nic al St u d y Pr ot oc ol  
C S R   
Cli nic al St u d y Re p ort  
C V %   
C oefficie nt of Variati o n  
C Y P   
C yt oc hr o me P 4 5 0  
D B P   
Diast olic Bl o o d Press ure  
D DI   
D r u g-D r u g Intera cti o n  
D M 
De m o gra p hics  
E C G   
Electr ocar di o gra m  
F  
Bi oa vaila bilit y Fa ct or  
F D A   
F o o d a n d Dr u g A d mi nistrati o n  
G G T   
Ga m ma -Gl uta m yltra nsferase  
G L P   
G o o d La b orat or y Practic es  
P P D


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V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
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G mea n   
Ge o metric  Mea n  
G M R   
Ge o metric Le ast S q uare Mea ns Rati o  
G C V %   
Ge o metric C oefficie nt of Variati o n  
G S D   
Ge o metr ic Sta n dar d De viati o n 
H 0 
N ull H y p ot hesis  
H 1 
Alter nati ve H y p ot hesis  
H Bs A g   
He patitis B S urfac e A nti ge n  
h C G   
H u ma n C h ori o nic G o na d otr o pi n  
H C V A b   
He patitis C Vir us A nti b o dies  
HI V   
H u ma n I m m u n o deficie nc y Vir us  
I C H  
I nter nati o nal C o nfere nc e o n Har m o nizati o n  
I N R  
I nter nati o nal N or malize d Rati o 
I S C V %  
I ntra-S u bject C oefficie nt of Variati o n  
I V 
I ntra ve n o us 
L C -M S/ M S  
Li q ui d C hr o mat o gra p h y wit h Ta n de m Mass S pectr o metr y  
L D H   
La ctate De h y dr o ge nase  
L L O Q   
L o wer Li mit of Q ua ntific ati o n  
L S me a ns   
Le ast S q ua re Mea ns 
M C H   
Mea n C or p usc ular He m o gl o bi n  
M C H C   
Mea n C or p usc ular He m o gl o bi n C o nc e ntrati o n  
M C V   
Mea n C or p usc ular V ol u me  
Me d D R A   
Me dic al Dicti o nar y f or Re g ulat or y Acti vities  
M S E   
Mea n S q uare Err or  
M W   
M ole c ular W ei g ht  
N C A   
N o n -C o m part me ntal A nal ysis  
P C  
P har ma c o ki netic C o nce ntrati o ns  
P C L   
Pr ot oc ol Clarific ati o n Letter  
P -g p 
P -Gl yc o pr otei n
P P
P har ma c o ki netic Para meters
P T
Me d D R A  Preferre d Ter m
Q Tc F 
C orre cte d Q T Inter val b y Fri dericia
R B C
Re d Bl o o d Cell
R D W -C V 
C oefficie nt Variati o n of t he Re d Cell Dist ri b uti o n Wi dt h
R S Q
G o o d ness of Fit f or t he Ter mi nal Eli mi nati o n P hase
rtf
Ric h Te xt File
S A E 
S eri o us A d verse E ve nt
S A P
Statistic al A nal ysis Pla n
S A R 
S eri o us A d verse Re a cti o n
S A R S -C o V -2  S e vere Ac ute Res pirat or y S y n dr o me C or o na vir us 2  
S A S   
Statistic al A nal ysis S oft ware  
S B P   
S yst olic Bl o o d Press ure  
S D  
Sta n dar d De viati o n  
S D T M    
St u d y Data Ta b ulati o n M o del  
S D T MI G   
St u d y Data Ta b ulati o n M o del I m ple me ntati o n G ui de 
S O C   
Me d D R A S yste m Or ga n Class  
S O P   
Sta n dar d O perati n g Pr oc e d ure  
T E A E    
Tr e at me nt -E mer ge nt A d verse E ve nts  
T F Ls    
Ta bles, Fi g ures a n d Listi n gs  
T ma x   
Ti me t o Ma xi m u m O bser ve d C o nce ntrati o n  
T ma x ,ss   
Ti me t o Ma xi m u m O bser ve d C o nce ntrati o n at Ste a d y State  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7  of 1 4 3  
T O S T   
T w o O ne -Si de d T -Tests  
T S H  
T h yr oi d -Sti m ulati n g H or m o ne  
t0 
Ti me of D os i n g (t = 0 h) 
t½  
A p pare nt Ter mi nal Eli mi nati o n Half -Life  
U L O Q   
U p per Li mit of Q ua ntificati o n  
V D  
A p pare nt V ol u me of Distri b uti o n  
V D / F  
A p pare nt V ol u me of Distri b uti o n Affe cte d b y t he Bi oa vaila bilit y Fa ct or ( F)  
W B C   
W hite Bl o o d Cell  
W H O   
W orl d Healt h Or ga nizati o n  
λ z 
A p pare nt Ter mi nal Eli mi nati o n Rate C o nsta nt  
τ 
D osi n g I nter val  
P P D


I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 8 of  1 4 3
3. 
I N T R O D U C TI O N
T his  St atisti c al  A n al ysis  Pl a n ( S A P)  d et ails t h e st atisti c al  m et h o d ol o g y t o  b e  us e d i n a n al y sin g st u d y
d at a  a n d  o utli n es t h e st atisti c al  pr o gr a m mi n g s p e cifi c ati o ns f or t h e T a bl es,  F i g ur es  a n d L isti n gs
( T F Ls). T his  d o c u m e nt  d es cri b es t h e  v ari a bl es  a n d  p o p ul ati o ns , a nti ci p at e d  d at a tr a nsf or m ati o n  a n d
m a ni p ul ati o ns  a n d  ot h er  d et ails  of t h e  a n al ysis  n ot  pr o vi d e d i n t h e  Cli ni c al  St u d y  Pr ot o c ol ( C S P).
T h e d es cri b e d  a n al ys es  ar e  b as e d  o n t h e  fi n al C S P  v ersi o n  1. 0,  d at e d  2 9 N O V 2 0 2 1 [ 1] a n d  a  Pr ot o c ol
Cl arifi c ati o n  L ett er ( P C L)  d at e d  2 5 F E B 2 0 2 2 . T his  S A P  w as fi n ali z e d pri or  t o d at a  b as e l o c k  a n d
c o n d u ct  of t h e st atisti c al  a n al ys es.  F or  e a c h  p art  of t h e st u d y  a t t h e ti m e  of t h e  Bli n d  R e vi e w
Pr o c ess,  a  D at a  Bli n d  R e vi e w  Pr o c ess  Mi n ut e  will  b e  pr e p ar e d  a n d  att a c h e d t o t his  d o c u m e nt
(A n n e x  5 ).
A d diti o n al  p h ar m a c o ki n eti c  a n d st atisti c al  a n al ysis  m a y  b e  p erf or m e d  t o s u p pl e m e nt t h e  pl a n n e d
a n al ys es  d es cri b e d i n t his  S A P .  Th es e  s u p pl e m e nt al a n al ys es  will  b e i d e ntifi e d a n d  pr es e nt e d i n t h e
Cli ni c al  St u d y  R e p ort ( C S R) .
4. 
S T U D Y  O B J E C TI V E S
4. 1. 
P ri m a r y
1. 
T o  e v al u at e t h e  pl as m a  a n d  uri n e  p h ar m a c o ki n eti cs  of  gi vi n ost at  a n d its  m et a b olit es
f oll o wi n g si n gl e  a n d  m ulti pl e  or al  d os es  of  gi vi n ost at ( P art  3).
4. 2. 
S e c o n d a r y
1. 
T o  ass ess t h e s af et y  a n d t ol er a bilit y  of si n gl e  a n d  m ulti pl e  d os es  of  gi vi n ost at ( P art  3).
5. 
I N V E S TI G A TI O N A L  P L A N
5. 1. 
St u d y  D esi g n
T his is  a  p h as e I,  o p e n -l a b el,  3-p art, fi x e d -s e q u e n c e,  n o n -r a n d o mi z e d st u d y i n  h e alt h y  m al e  a n d 
f e m al e s u bj e cts.
St u d y  p arts  m a y  b e  c o n d u ct e d  c o n c o mit a ntl y.
R ati o n al f o r St u d y  D esi g n
T h e r ati o n al f or st u d y  d esi g n  d et ail e d i n t h e  C S P [ 1].
I n P art  3 , t h e  p h ar m a c o ki n eti cs  of  gi vi n ost at  a n d its  m et a b olit es i n  pl as m a  a n d  uri n e f oll o wi n g 
si n gl e - a n d  m ulti pl e -d os es  of  gi vi n ost at will  b e i n v esti g at e d.
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n  
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9  of 1 4 3  
5. 2.   
St u d y Pl a n  
P art 3 –  P h ar m ac o ki n etics of Gi vi n ost at a n d its Met a b olites F oll o wi n g Si n gle a n d M ulti ple 
Or al D oses of Gi vi n ost at  
S u bje cts will be c o nfi ne d i n 
 fr o m Da y -1 t o Da y 1 7. 
O n Da y 1 a n d Da y 1 3, gi vi n ostat 5 0 m g as oral s us pe nsi o n will be a d mi nistere d as a si n gle d ose, i n 
t he m or ni n g, f oll o wi n g a n o ver ni g ht fasti n g of at le ast 8 h o urs a n d s u bje cts will re mai n faste d u ntil 
at le ast 4 h o urs p ost d ose. N o fl ui ds will be all o we d fr o m 1 h o ur bef ore d osi n g u ntil 2 h o urs p ost 
d ose. W ater will be pr o vi de d a d li bit u m at all ot her ti mes.  
Fr o m Da y 5 t o Da y 1 2, s u bje cts will rec ei ve gi vi n ostat 5 0 m g as oral s us pe nsi o n, t wic e a da y, i n t he 
m or ni n g a n d i n t he e ve ni n g. O n Da ys 1 a n d 1 3, gi vi n ostat will be a d mi nistere d wit h t he s u bje cts i n a 
se mi-rec u m be nt p ositi o n a n d will re mai n se mi-re c u m be nt u ntil at le ast 4 h o urs p ost-d ose.  
T he f oll o wi n g assess me nts will be perf or m e d: 
- 
Bl o o d c olle cti o n f or p har ma c o ki netic a nal ysis o n Da ys 1 t o 5 a n d 9 t o 1 7.
- 
Uri ne c ollecti o n f or p har mac o ki netic a nal ysis o n Da ys 1 t o 5 a n d 1 3 t o 1 7 ( Baseli ne uri ne
c olle cti o n is o n da y -1).
- 
Vital si g ns me as ure me nts ( B P, P R a n d R R) o n Da ys 1 a n d 5 t o 1 3 .
- 
1 2 -le a d E C G o n Da ys 1 a n d 4 t o 1 3.
- 
Bl o o d c olle cti o n f or la b orat or y tests ( he mat ol o g y a n d bi oc he mistr y o n Da y 9 a n d
he mat ol o g y o n Da ys 6 a n d 1 3).
S u bje cts will be disc har ge d fr o m 
o n t he m or ni n g of Da y 1 7 if all o we d b y t he 
i n vesti gat or base d o n t heir me dic al c o n diti o n. T he f oll o wi n g pr oc e d ures will be perf or me d:  
- 
P h ysic al e xa mi nati o n.
- 
C olle cti o n of b o d y wei g ht.
- 
Vital si g ns me as ure me nts ( B P, P R, R R a n d b o d y te m perat ure).
- 
1 2 -le a d E C G.
- 
S afet y la b orat or y assess me nts ( he mat ol o g y, bi oc he mistr y , c oa g ulati o n a n d uri nal ysis).
- 
S er u m pre g na nc y test f or all fe male s u bje cts.
S u bje cts will ret ur n t o 
 1 0 t o 1 4 da ys after t he e n d of st u d y t o u n der g o 
a d diti o nal assess me nts as re q uire d as per pr ot oc ol.  
T he t otal d urati o n of Part 3 f or ea c h s u bject will be u p t o a p pr o xi matel y 8 we e ks fr o m S cree ni n g t o 
F oll o w -u p visit, di vi de d as f oll o ws:  
- 
S cre e ni n g: u p t o 2 1 da ys
- 
Tr e at me nt Peri o d: Da ys 1 t o 1 7
- 
S afet y f oll o w -u p visit: 1 2 ± 2 da ys
5. 3.   
N u m b er of P artici p a nts  a n d S a m ple S ize Esti m a ti o n 
T o e ns ure e n o u g h s u bje cts wit h e val ua ble data c o m plete e a c h st u d y part, a t otal of fift y-f o ur (5 4 ) 
he alt h y male a n d fe male s u bje cts are pla n ne d t o be e nr olle d as f oll o ws:  
- 
Part 1: t we nt y-si x (2 6 ) s u bje cts
- 
Part 2: t we nt y (2 0 ) s u bje cts
P P D
P P D
P P D
P P D


I T F/ 2 3 5 7/ 55
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D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 9 of  1 4 3
5. 2. 
St u d y  Pl a n
P a rt  3  – P h a r m a c o ki n eti cs  of  Gi vi n ost at  a n d its  M et a b olit es  F oll o wi n g  Si n gl e  a n d  M ulti pl e 
O r al  D os es  of  Gi vi n ost at
S u bj e cts  will  b e  c o nfi n e d i n 
 fr o m  D a y -1 t o  D a y  1 7. 
O n  D a y  1  a n d  D a y  1 3,  gi vi n ost at  5 0  m g  as  or al s us p e nsi o n  will  b e  a d mi nist er e d  as  a si n gl e  d os e, i n 
t h e  m or ni n g, f oll o wi n g  a n  o v er ni g ht f asti n g  of  at l e ast  8  h o urs  a n d s u bj e cts  will r e m ai n f ast e d  u ntil 
at l e ast  4  h o urs  p ost  d os e.  N o fl ui ds  will  b e  all o w e d fr o m  1  h o ur  b ef or e  d osi n g  u ntil  2  h o urs  p ost 
d os e.  W at er  will  b e  pr o vi d e d  a d li bit u m  at  all  ot h er ti m es.
Fr o m  D a y  5 t o  D a y  1 2, s u bj e cts  will r e c ei v e  gi vi n ost at  5 0  m g  as  or al s us p e nsi o n, t wi c e  a  d a y, i n t h e 
m or ni n g  a n d i n t h e  e v e ni n g.  O n  D a ys  1  a n d  1 3,  gi vi n ost at  will  b e  a d mi nist er e d  wit h t h e s u bj e cts i n  a 
s e mi-r e c u m b e nt  p ositi o n  a n d  will r e m ai n s e mi-r e c u m b e nt  u ntil  at l e ast  4  h o urs  p ost-d os e.
T h e f oll o wi n g  ass ess m e nts  will  b e  p erf or m e d:
- 
Bl o o d  c oll e cti o n f or  p h ar m a c o ki n eti c  a n al ysis  o n  D a ys  1 t o  5  a n d  9 t o  1 7.
- 
Uri n e  c oll e cti o n f or  p h ar m a c o ki n eti c  a n al ysis  o n  D a ys  1 t o  5  a n d  1 3 t o  1 7 ( B as eli n e  uri n e
c oll e cti o n is  o n  d a y  -1).
- 
Vit al si g ns  m e as ur e m e nts ( B P,  P R  a n d  R R)  o n  D a ys  1  a n d  5 t o  1 3 .
- 
1 2 -l e a d  E C G  o n  D a ys  1  a n d  4 t o  1 3.
- 
Bl o o d  c oll e cti o n f or l a b or at or y t ests ( h e m at ol o g y  a n d  bi o c h e mistr y  o n  D a y  9  a n d
h e m at ol o g y  o n  D a ys  6  a n d  1 3).
S u bj e cts  will  b e  dis c h ar g e d fr o m 
o n t h e  m or ni n g  of  D a y  1 7 if  all o w e d  b y t h e 
i n v esti g at or b as e d  o n t h eir  m e di c al  c o n diti o n.  T h e f oll o wi n g  pr o c e d ur es  will  b e  p erf or m e d:
- 
P h ysi c al  e x a mi n ati o n.
- 
C oll e cti o n  of  b o d y  w ei g ht.
- 
Vit al si g ns  m e as ur e m e nts ( B P,  P R,  R R  a n d  b o d y t e m p er at ur e).
- 
1 2 -l e a d  E C G.
- 
S af et y l a b or at or y  ass ess m e nts ( h e m at ol o g y,  bi o c h e mistr y ,  c o a g ul ati o n  a n d  uri n al ysis).
- 
S er u m  pr e g n a n c y t est f or  all f e m al e s u bj e cts.
S u bj e cts  will r et ur n t o 
  1 0 t o  1 4  d a ys  aft er t h e  e n d  of st u d y t o  u n d er g o 
a d diti o n al  ass ess m e nts  as r e q uir e d  as  p er  pr ot o c ol.
T h e t ot al  d ur ati o n  of  P art  3  f or  e a c h s u bj e ct  will  b e  u p t o  a p pr o xi m at el y  8  w e e ks fr o m  S cr e e ni n g t o 
F oll o w -u p  visit,  di vi d e d  as f oll o ws:
- 
S cr e e ni n g:  u p t o  2 1  d a ys
- 
Tr e at m e nt  P eri o d:  D a ys  1 t o  1 7
- 
S af et y f oll o w -u p  visit:  1 2 ± 2  d a ys
5. 3. 
N u m b e r  of  P a rti ci p a nts a n d  S a m pl e  S i z e Esti m a ti o n
T o  e ns ur e  e n o u g h s u bj e cts  wit h  e v al u a bl e  d at a  c o m pl et e  e a c h  st u d y  p art,  a t ot al  of fift y-f o ur (5 4 )
h e alt h y  m al e  a n d f e m al e s u bj e cts  ar e  pl a n n e d t o  b e  e nr oll e d  as f oll o ws:
- 
P art  1:  t w e nt y-si x (2 6 ) s u bj e cts
- 
P art  2:  t w e nt y (2 0 ) s u bj e cts
P P D
P P D
P P D
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0  of 1 4 3  
- 
Part 3: ei g ht ( 8 ) s u bje cts
Ea c h s u bject will partici pate i n o ne st u d y part o nl y.  
P art 3  
A sa m ple size of 8 s u bje cts will be e nr olle d. T he sa m ple size was deter mi ne d b y practic al 
c o nsi derati o ns a n d n ot base d o n statistic al p o wer calc ulati o ns.  
5. 4.   
R a n d o miz ati o n  
T his is a fi x e d se q ue nc e st u d y. Ra n d o mizati o n is n ot a p plic a ble.  
5. 5.   
Bli n di n g  
T he st u d y will be c o n d ucte d as o pe n la bel. Bli n di n g pr oce d ures are n ot a p plic a ble.  
6. 
S T U D Y A S S E S S M E N T S
F or e a c h st u d y part, a  s u m mar y of pr oce d ures f or st u d y assess me nts are prese nte d i n S ecti o n 2 of
t he C S P ( St u d y Fl o w-C hart a n d St u d y Desi g n Dia gra m)  [1 ].
6. 1.   
S afet y Assess me nts  
S u bje cts’ safet y will be m o nit ore d d uri n g t he st u d y.  
S afet y assess me nts will i ncl u de pre -st u d y me dical hist or y, p h ysic al e xa mi nati o n, vital si g ns, 1 2-le a d 
E C G, cli nic al la b orat or y tests a n d a d verse e ve nt ( A E ) m o nit ori n g. A d diti o nal safet y me as ure me nts 
ma y be perf or me d at t he discreti o n of t he i n vesti gat or f o r re as o ns relate d t o s u bject safet y. 
Me dic ati o ns will be me nti o ne d ac c or di n g t o t he W orl d He alt h Or ga nizati o n ( W H O) A nat o mic al 
T hera pe utic C he mical ( A T C) classific ati o n s yste m.  
M e dic al Hist or y  
Me dic al hist or y will c o ver all rele va nt past or prese nt i nf o r mati o n relate d t o s u bject’s healt h at t he 
ti me of i nf or me d c o nse nt si g nat ure. 
Me dic al hist or y at scre e ni n g will i ncl u de past or prese nt rele va nt car di o vasc ular, res pirat or y, re nal, 
ge nit o uri nar y, gastr oi ntesti nal, he patic, he mat ol o gic al, i m m u n ol o gic al, e n d ocri ne, der mat ol o gic al, 
m usc ul os keletal, ne ur ol o gical, ps yc hiatric, dr u g a n d s ur gic al hist or y, or a n y ot her diseases or 
dis or ders.  
Me dic al hist or y will be referre d i n a cc or da nc e wit h t he Me dic al Dicti o nar y f or Re g ulat or y Acti vities 
( Me d D R A), versi o n 2 4.1  or hi g her.  
A d verse e ve nts relate d t o me dic al hist or y will be i de ntifie d.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1  of 1 4 3  
P h ysic al E x a mi n ati o n  
P h ysic al e xa mi nati o n at scre e ni n g a n d e n d -of -st u d y will i ncl u de: ge neral a p pe ara nc e; s ki n; he a d a n d 
ne c k; t h ora x a n d a b d o me n; p ul m o nar y a usc ultati o n; car dia c a usc ultati o n; a b d o me n pal pati o n; li m bs; 
brief ne ur ol o gic al e xa mi nati o n.  
Wei g ht, Hei g ht a n d B o d y M ass I n de x 
T he b o d y hei g ht a n d wei g ht val ues as well as t he b o d y mass i n de x ( B MI ) will be re c or de d i n t he 
ele ctr o nic c ase re p ort f or m (e C R F) a n d will be deter mi ne d at S cree ni n g. O nl y b o d y wei g ht will be 
deter mi ne d als o at a d missi o n a n d e n d -of -st u d y. 
T he s u bje cts’ b o d y wei g ht will prefera bl y be me as ure d usi n g t he sa me wei g hi n g scale f or all 
s u bje cts a n d t hr o u g h o ut t he st u d y. T he weig hi n g scale s h o ul d ha ve a pre cisi o n of at le ast 0. 5 k g.  
Vit al Si g ns  
Vital si g ns will i ncl u de:  
- 
S yst olic bl o o d press ure ( S B P).
- 
Diast olic bl o o d press ure ( D B P) .
- 
P ulse rate  ( P R).
- 
Res pirat or y rate ( R R ).
- 
B o d y te m perat ure.
1 2 Le a d Ele ctr oc ar di o gr a m  
A 1 2 -le a d E CG will be perf or me d  prefera bl y bef ore t he bl o o d c olle cti o n . T he c orre cte d Q T i nter val 
b y Fri dericia (Q Tc F ) will be a nal yze d.  
L a b or at or y S afet y Tests  
T he f oll o wi n g la b orat or y para meters will be teste d: 
- 
He mat ol o g y:
- 
Re d bl o o d c ell ( R B C) c o u nt.
- 
W hite bl o o d c ell ( W B C) c o u nt.
- 
W B C differe ntial c o u nt:
- 
Ne utr o p hils.
- 
E osi n o p hils.
- 
Bas o p hils.
- 
L y m p h oc ytes.
- 
M o n oc ytes.
- 
He m o gl o bi n.
- 
Mea n c or p usc ular v ol u me ( M C V).
- 
Mea n c or p usc ular he m o gl o bi n ( M C H).
- 
Mea n c or p usc ular he m o gl o bi n c o nce ntrati o n ( M C H C).
- 
C oefficie nt variati o n of t he re d c ell distri b uti o n wi dt h ( R D W -C V).
- 
He mat ocrit .
- 
Platelet c o u nt.
- 
Mea n platelet v ol u me.
P P D


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St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2  of 1 4 3  
- 
C oa g ulati o n:
- 
Pr ot hr o m bi n rate.
- 
Pr ot hr o m bi n ti me.
- 
Pr ot hr o m bi n ti me –  i nter nati o nal n or malize d rati o (I N R).
- 
Acti vate d partial t hr o m b o plasti n ti me (a P T T).
- 
Ge neral bi oc he mistr y:
- 
T otal bilir u bi n.
- 
Dire ct bilir u bi n.
- 
I n dire ct bilir u bi n.
- 
Al kali ne p h os p hatase ( A L P).
- 
A m ylase.
- 
As partate a mi n otra nsferase ( A S T).
- 
Ala ni ne a mi n otra nsferase ( A L T).
- 
La ctate de h y dr o ge nase ( L D H).
- 
C ystati n  C .
- 
C -re acti ve pr otei n.
- 
Ga m ma -gl uta m yltra nsferase ( G G T).
- 
Cre ati ni ne ki nase ( C K ).
- 
T otal pr otei n.
- 
Al b u mi n.
- 
Uric aci d.
- 
Tri gl yc eri des.
- 
T otal c h olester ol.
- 
L o w -de nsit y li p o pr otei n -c h olester ol ( L D L -C) .
- 
Hi g h -de nsit y li p o pr otei n -c h olester ol ( H D L-C) .
- 
S o di u m.
- 
P otassi u m.
- 
C hl ori de.
- 
Calci u m.
- 
Ma g nesi u m.
- 
Gl uc ose.
- 
Cre ati ni ne.
- 
Urea.
- 
T h yr oi d -sti m ulati n g h or m o ne (T S H ).
- 
Esti mate d creati ni ne cleara nce  ( CrC L ).
- 
Viral Ser ol o g y:
- 
H u ma n I m m u n o deficie nc y Vir us ( HI V):
- 
HI V -1 (a nti -HI V -1 A b).
- 
HI V -2 (a nti -HI V -2 A b).
- 
He patitis B ( H Bs A g)
- 
He patitis C (a nti -H C V A b).
- 
Beta -h u ma n c h ori o nic g o na d otr o pi n ( beta -h C G) pre g na nc y tests:
- 
S er u m.
- 
Uri ne.
- 
Uri nal ysis:
- 
p H.
P P D


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St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3  of 1 4 3  
- 
S pe cific gra vit y.
- 
Pr otei n.
- 
He m o gl o bi n.
- 
Gl uc ose.
- 
Ket o nes.
- 
Bilir u bi n.
- 
Nitrites.
- 
Ur o bili n o ge n.
- 
Micr osc o p y.
- 
Dr u gs -of -a b use uri ne test:
- 
Ca n n a bi n oi ds.
- 
O piates.
- 
C oc ai ne.
- 
A m p heta mi nes.
- 
Be nz o dia ze pi nes.
- 
Et ha n ol uri ne test.
- 
C oti ni ne uri ne test.
- 
F ollicle -sti m ulati n g h or m o ne ( F S H) test.
- 
S e vere Ac ute Res pirat or y S y n dr o me C or o na vir us 2 ( S A R S -C o V -2) dia g n ostic tests.
A d verse E ve nts  
T he occ urre nce of cli nical A Es will be m o nit ore d t hr o u g h o ut t he st u d y.  
Cli nic all y si g nific a nt a b n or malities i n la b orat or y safet y tests, vital si g ns  a n d p h ysic al e xa mi nati o n 
will be re p orte d as A Es.  
Tr e at me nt -e mer ge nt A Es ( T E A Es) are defi ne d as A Es n ot prese nt pri or t o first a d mi nistrati o n of 
i n vesti gati o nal pr o d uct, or A Es prese nt bef ore first a d mi nistrati o n of i n vesti gati o nal pr o d uct t hat 
w orse n after t he s u bje ct re cei ves t he first d ose of i n vesti gati o nal pr o d uct. T E A Es t hat oc c ur after 
a d mi nistrati o n of i n vesti gati o nal pr o d uct d uri n g t he was h o ut of a gi ve n peri o d will be assi g ne d t o 
t he tre at me nt a d mi nistere d i n t hat peri o d. 
T he f oll o wi n g i nf or mati o n will be use d f or t he descri pti o n of t he A Es: 
- 
Re p orte d Ter m.
- 
Me dic al Dicti o nar y f or Re g ulat or y Acti vit ies ( Me d D R A) S yste m Or ga n Class ( S O C)
c o di n g.
- 
Me d D R A Preferre d Ter m ( P T) c o di n g.
- 
Start date a n d ti me.
- 
E n d date a n d ti me.
- 
S eri o us ness.
- 
S e verit y:
- 
Mil d.
- 
M o derate.
- 
S e vere.
- 
Relati o ns hi p (c a usalit y)  f or ea c h tre at me nt a d mi nistrate d , per part.
- 
Re as o na bl y P ossi ble.
- 
N ot Re as o na bl y P ossi ble.
- 
U n k n o w n.
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 4  of 1 4 3  
- 
Acti o n ta ke n:
- 
D ose I ncrease d.
- 
D ose N ot C ha n ge d.
- 
D ose Rate Re d uc e d.
- 
D ose Re d uce d.
- 
Dr u g I nterr u pte d.
- 
Dr u g Wit h dra w n.
- 
N ot A p plic a ble.
- 
U n k n o w n.
- 
C o nc o mita nt me dic ati o n.
- 
O utc o me:
- 
Fatal.
- 
N ot Re c o vere d / N o t Res ol ve d.
- 
Re c o vere d / Res ol ve d.
- 
Re c o vere d / Res ol ve d wit h Se q uelae.
- 
Re c o veri n g / Res ol vi n g.
- 
U n k n o w n.
- 
M ost re c e nt st u d y treat me nt ta ke n.
- 
Last d osi n g date.
Pr e vi o us a n d C o nc o mit a nt Me dic ati o ns  
A pre vi o us me dicati o n is a n y me dic ati o n f or w hic h t he e n d date is pri or t o first d osi n g.  
A c o nc o mita nt me dicati o n is a n y me dic ati o n o n g oi n g or i nitiate d after first d osi n g.  
F or all st u d y parts, the use of a n y me dic ati o ns i ncl u di n g O ver -t he-C o u nter ( O T C) pr o d ucts 
(i ncl u di n g her bal me dici nes s uc h as St J o h n’s W ort, h o me o pat hic pre parati o ns, vita mi ns, a n d 
mi nerals) is f or bi d de n fr o m 2 8 da ys or wit hi n 5 half -li ves of t he me dici nal pr o d uct, w hic he ver is 
l o n ger, pri or t o a d missi o n u p t o last sa m ple f or p har mac o ki netics assess me nt, e xc e pt f or me dic ati o ns 
f or t he tre at me nt of A Es. 
A n y me dic ati o n ( pre vi o us or c o nc o mita nt) ta ke n wit hi n t he peri o d of me dic ati o n restricti o n m ust be 
re c or de d i n t he e C R F. If c o nc o mita nt me dic ati o n is o n g oi n g at t he f oll o w-u p visit, n o e n d date will 
be pr o vi de d i n t he e C R F.  
F or e a c h st u d y part, pre vi o us a n d c o nc o mita nt me dicati o ns use d b y st u d y partici pa nts d uri n g t he 
st u d y a n d t heir j u d ge d i m pa ct o n t he p har mac o ki netic assess me nt will be liste d i n t he res pecti ve 
Data Bli n d Re vie w Meeti n g/ Pr oc ess Mi n ute ( A n ne x 5 ).  
C o nc o mita nt me dic ati o ns will be c o de d a c c or di n g t o t he W H O A T C classific ati o n s yste m. 
6. 2.   
P h ar m ac o ki n etic Assess me nts  
Bl o o d S a m pli n g f or P h ar m ac o ki netic Assess me nts  
I n e a c h st u d y part, w hile s u bject is c o nfi ne d at t he cli nical researc h u nit, bl o o d sa m ples will be ta ke n 
prefera bl y via a n i n d welli n g ca n n ula plac e d i n a vei n of a n u p per li m b of t he s u bje ct. D uri n g 
a m b ulat or y visits, bl o o d sa m ples will be ta ke n b y direct ve ni p u nct ure.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 5  of 1 4 3  
T he act ual ti me of all p har m a c o ki netic bl o o d dra ws will be rec or de d a n d re p orte d f or all s u bje cts. 
T he pre -d ose bl o o d sa m ple will be c olle cte d wit hi n 3 0 mi n utes bef ore d osi n g. T he p ost -d ose bl o o d 
sa m ples will be c olle cte d wit hi n ± 3 mi n utes fr o m t he sc he d ule d sa m pli n g ti me. Gre ater de viati o ns 
will be re p orte d as a pr ot oc ol de viati o n a n d its ca use will be rec or de d.  
I n c ase bl o o d sa m pli n g f or p har ma c o ki netics a n d ot her pr oc e d ures c oi nci de i n ti me, bl o o d dra ws 
will ha ve pri orit y u nless ot her pr oc e d ures are ne cessar y f or ass uri n g s u bje ct’s safet y. 
 will c arr y o ut t he deter mi nati o n of plas ma le vels of gi vi n ostat a n d its 
meta b olites  (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3), mi da z ola m, 1-h y dr o x y mi da z ola m a n d t otal 
a n d fre e da bi gatra n i n a cc or da nc e wit h t he a p plic a ble pri nci ples of G o o d La b orat or y Pra ctices 
( G L P), usi n g a pre vi o usl y vali date d li q ui d c hr o mat o gra p h y wit h ta n de m mass s pectr o metr y ( L C-
M S/ M S) a nal ytic al met h o d.  
T he pla n ne d l o wer li mit of q ua ntific ati o n ( L L O Q) a n d u p per li mit of q ua ntific ati o n ( U L O Q) f or:  
- 
gi vi n ostat are 1  a n d 1 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 3 7 4 are 1  a n d 1 0 0 n g / m L.
- 
gi vi n ostat meta b olite I T F 2 3 7 5 are 1  a n d 1 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 4 4 0 are 1 0  a n d 5 0 0  n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 5 6 3  are 2  a n d 1 2 5  n g/ m L .
- 
mi da z ola m are 1 0 0  a n d 1 0 0 0 0 0 p g/ m L .
- 
1 -h y dr o x y mi da z ola m are 1 0 0  a n d 5 0 0 0 0 p g/ m L .
- 
t otal da bi gatra n are 1  a n d 4 0 0 n g/ m L .
- 
free da bi gatra n are 1  a n d 4 0 0 n g/ m L .
L L O Q re prese nts a val ue l o wer t ha n or e q ual t o 1/ 2 0 of esti mate d C ma x  val ue. A n y a dj ust me nt t o t his 
ra n ge will be d oc u me nte d i n t he st u d y s pecific Bi oa nal ytic al Re p ort, w hic h will s u perse de t he 
i n dic ate d ra n ge. 
6. 2. 1. 1.  P art 3  
A t otal of f ort y-ei g ht ( 4 8 ) bl o o d sa m ples will be c ollecte d as f oll o ws:  
- 
T we nt y -t w o ( 2 2) bl o o d sa m ples of 6 m L ea c h will be c olle cte d i n s o di u m he pari n t u bes at
pre -d ose a n d at 0. 5, 1, 1. 5, 2, 2. 5, 3, 3. 5, 4, 5, 6, 8, 1 0, 1 2, 1 5, 2 4, 3 6, 4 8, 6 0, 7 2, 8 4 a n d 9 6
h o urs after t he a d mi nistrati o n of gi vi n ostat, o n Da ys 1 a n d 1 3, f or t he deter mi nati o n of
gi vi n ostat a n d its meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3) plas ma
c o nc e ntrati o ns.
- 
F o ur ( 4) bl o o d sa m ples of 6 m L ea c h will be c olle cte d i n s o di u m he pari n t u bes bef ore t he
m or ni n g d ose of gi vi n ostat o n Da ys 9, 1 0, 1 1 a n d 1 2, f or t he deter m i nati o n of pre-d ose
( Ctr o u g h) plas ma c o nc e ntrati o n of gi vi n ostat a n d meta b olites.
Uri n e S a m pli n g f or P h ar m ac o ki n etic Assess me nts  
6. 2. 2. 1.  P art 3  
Uri ne will be c ollecte d o n Da y -1 ( baseli ne) a n d i n t he f oll o wi n g i nter vals, o n Da ys 1 a n d 1 3, f or t he 
deter mi nati o n of t he a m o u nts of gi vi n ostat a n d its meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d 
I T F 2 5 6 3) e xcrete d i n uri ne: 0– 1 2, 1 2 – 2 4, 2 4 – 3 6, 3 6 – 4 8, 4 8 – 7 2 a n d 7 2 – 9 6 p ost -d ose.  
P P D
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 6  of 1 4 3  
T he date a n d act ual ti me of uri ne c olle cti o n start a n d c o m pleti o n will be re c or de d a n d re p ort e d f or 
all s u bje cts. 
 will c arr y o ut t he deter mi nati o n of uri ne le vels of gi vi n ostat a n d its 
meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3) i n a c c or da nc e wit h t he a p plic a ble pri nci ples 
of G L P usi n g a pre vi o usl y vali date d li q ui d c hr o mat o gra p h y wit h ta n de m mass s pectr o metr y ( L C-
M S/ M S) a nal ytic al met h o d. 
T he pla n ne d l o wer li mit of q ua ntific ati o n ( L L O Q) a n d u p per li mit of q ua ntific ati o n ( U L O Q) f or:  
- 
gi vi n ostat are 1 0  a n d 2 5 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 3 7 4 are 5  a n d 2 5 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 3 7 5 are 4  a n d 8 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 4 4 0 are 1 5 0  a n d 2 5 0 0 0 n g/ m L .
- 
gi vi n ostat meta b olite I T F 2 5 6 3  are 1 0  a n d 5 0 0 0 n g/ m L .
Pl as m a P h ar m ac o ki n etic P ar a meters  
T he f oll o wi n g p har ma c o ki netic para meters will be deri ve d b y sta n dar d n o n -c o m part me ntal a nal ysis 
( N C A) met h o ds fr o m t he si n gle-d ose plas ma c o nce ntrati o n v ers us ti me pr ofiles, f or: 
- 
Part 3  ( Da y 1):
- 
gi vi n ostat.
- 
gi vi n ostat meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3).
P ar a meter   
Descri pti o n  
C ma x  
Ma xi m u m o bser ve d c o nc e ntrati o n, dire ctl y o btai ne d fr o m t he o bser ve d 
c o nc e ntrati o n v ers us ti me pr ofile. 
T ma x  
Ti me of oc c urre nce of ma xi m u m o bser ve d c o nc e ntrati o n.  
A U C 0 -t 1
Area u n der t he c o nc e ntrati o n v ers us ti me c ur ve ( A U C) fr o m ti me of d osi n g 
(t = 0 h) t o t he ti me of t he last meas ura ble c o nc e ntrati o n (t last), calc ulate d b y 
t he li ne ar-u p/l o g -d o w n tra pe z oi dal met h o d.  
A U C 0 -∞ 
T otal A U C e xtra p olate d t o i nfi nit y, c alc ulate d as A U C 0 −t +
C l a st
λ z , w here Clast 
is t he last me as ura ble c o nce ntrati o n a n d λz is t he a p pare nt ter mi nal 
eli mi nati o n rate c o nsta nt. 
% A U C
e xtra p  
Perc e nta ge of A U C 0 -∞ d ue t o e xtra p olati o n fr o m t he ti me of t he last 
me as ura ble c o nc e ntrati o n (t
last) t o i nfi nit y, i.e., resi d ual are a, calc ulate d as 
1 0 0 ∙
A U C 0 −∞−A U C 0 −t
A U C 0 −∞
. 
λ z 
A p pare nt first or der eli mi nati o n rate c o nsta nt ass ociate d wit h t he ter mi nal 
(l o g-li ne ar) p orti o n of t he c o nce ntrati o n vers us ti me c ur ve. T he para meter is 
esti mate d b y li ne ar least s q uare re gressi o n a nal ysis usi n g t he last t hre e ( or 
m ore) n o n -zer o c o nc e ntrati o ns.  
t½  
A p pare nt ter mi nal eli mi nati o n half -life, calc ulate d as 
𝑙𝑛(2 )
λ z . 
1 I n P art 3 , f or givi n ost at a n d its met a b olites  t he l ast s a m pli n g ti me c orres p o n ds t o 9 6  h o urs.  
P P D
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 7  of 1 4 3  
T he u p per a n d t he l o wer ti me p oi nts a n d t he n u m ber of ti me p oi nts use d f or λ z esti mati o n, as well as 
t he g o o d ness of fit f or t he ter mi nal eli mi nati o n p hase ( R S Q), will be re p orte d.  
N o val ues of λ z, A U C0 -∞, % A U Ce xtra p a n d t ½  will be re p orte d f or c ases w here λ z c a n n ot be relia bl y 
deter mi ne d.  
T he f oll o wi n g p har ma c o ki netic para meter s will be deri ve d b y sta n dar d N C A met h o ds fr o m t he 
m ulti ple -d ose plas ma c o nce ntrati o n vers us ti me pr ofiles, f or: 
- 
Part 3  ( Da y 1 3):
- 
gi vi n ostat.
- 
gi vi n ostat meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3).
P ar a meter   
Descri pti o n  
C ma x,ss  
Ma xi m u m o bser ve d plas ma c o nce ntrati o n at stea d y state, dire ctl y o btai ne d 
fr o m t he o bser ve d c o nc e ntrati o n v ers us ti me pr ofile. 
T ma x ,ss 
Ti me of oc c urre nce of ma xi m u m o bser ve d plas ma c o nc e ntrati o n  at ste a d y 
state. 
A U C 0 -τ,ss 
Area u n der t he plas ma c o nc e ntrati o n v ers us ti me c ur ve c orres p o n di n g t o 
d osi n g i nter val , i.e., 1 2 h o urs, after stea d y state has bee n re a c he d. T his 
para meter is calc ulate d b y t he li ne ar -u p/l o g -d o w n tra pe z oi dal met h o d.  
A U C 0 -t 
A U C fr o m ti me of d osi n g (t = 0 h) t o t he ti me of t he last me as ura ble 
c o nc e ntrati o n (t last), c alc ulate d b y t he li near-u p/l o g -d o w n tra pe z oi dal 
met h o d.  
A U C 0 -∞ 
T otal A U C e xtra p olate d t o i nfi nit y, c alc ulate d as A U C 0 −t +
C l a st
λ z , w here Clast 
is t he last me as ura ble c o nce ntrati o n a n d λz is the a p pare nt ter mi nal 
eli mi nati o n rate c o nsta nt. 
λ z 
A p pare nt first or der eli mi nati o n rate c o nsta nt ass ociate d wit h t he ter mi nal 
(l o g-li ne ar) p orti o n of t he c o nce ntrati o n vers us ti me c ur ve. T he para meter is 
esti mate d b y li ne ar least s q uare re gressi o n a nal ys is usi n g t he last t hre e ( or 
m ore) n o n -zer o c o nc e ntrati o ns.  
t½  
A p pare nt ter mi nal eli mi nati o n half -life, calc ulate d as 
𝑙𝑛(2 )
λ z . 
C L ss/ F 
A p pare nt t otal b o d y cle ara nc e affe cte d b y t he bi oa vaila bilit y fa ct or ( F), 
c alc ulate d as 
𝐷𝑜𝑠𝑒
A U C 0 −τ ,s s . 
V D / F 
A p pare nt v ol u me of distri b uti o n affecte d b y F, calc ulate d as 
𝐷𝑜𝑠𝑒
λ z  ∙ A U C 0 −τ ,s s . 
T he u p per a n d t he l o wer ti me p oi nts a n d t he n u m ber of ti m e p oi nts use d f or λ z esti mati o n, as well as 
t he R S Q, will be re p orte d.  
N o val ues of λ z, A U C0 -∞, % A U Ce xtra p a n d t ½  will be re p orte d f or c ases w here λ z c a n n ot be relia bl y 
deter mi ne d.  
F or e a c h st u d y part, p har ma c o ki netic para meters will be esti mate d fr o m t he plas ma  c o nc e ntrati o n 
v ers us ti me pr ofiles f or all s u bje cts i n ea c h p har mac o ki netic a nal ysis p o p ulati o n.  
Act ual sa m pli n g ti mes will be use d f or t he p har mac o ki netic a nal ysis. All c alc ulati o ns will be 
perf or me d usi n g ra w data.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 8  of 1 4 3  
I n esti mati n g t he p har ma c o ki netic para meters, c o nce ntrati o ns bel o w t he L L O Q bef ore T ma x  will be 
set t o zer o. After T ma x , c o nce ntrati o ns bel o w t he L L O Q will be c o nsi dere d as missi n g. H o we ver, i n 
c ase of t w o or m ore c o nsec uti ve c o nc e ntrati o ns bel o w t he L L O Q, t he first  val ue will be re pla ce d b y 
½ of t he L L O Q val ue a n d t he ne xt val ues will be c o nsi dere d as missi n g.  
A d diti o nal p har ma c o ki netic para meters ma y be c alc ulate d f or t he plas ma c o nce ntrati o n  vers us ti me 
pr ofiles, if c o nsi dere d a p pr o priate a n d j ustifie d at t he ti m e of t he p har ma c o ki netic a nal ysis.  
Uri n ar y  P h ar m ac o ki netic P ar a mete rs  
T he f oll o wi n g p har ma c o ki netic para meters will be deri ve d b y sta n dar d N C A met h o ds fr o m t he uri ne  
e xcreti o n  pr ofiles, f or  t he first d ose ( Da y 1, si n gle-d ose ) a n d t he last d ose ( Da y 1 3, m ulti ple -d ose ): 
- 
Part 3:
- 
gi vi n ostat.
- 
gi vi n ostat meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3).
P ar a meter   
Descri pti o n  
R ma x  
Ma xi m u m o bser ve d uri nar y e xcreti o n rate . 
t uma x  
Ti me of oc c urre nce of ma xi m u m uri nar y e xcreti o n rate . 
A mt C U M  
C u m ulati ve a m o u nt of dr u g e xcrete d i n uri ne , calc ulate d as 
∑(𝑙𝑛𝐷𝑜𝑠𝑒𝐷𝑜𝑠𝑒𝑖𝑜𝑛∙𝑉𝑜𝑙𝑢𝑚𝑒) 
A U R C 0 -t 
Area u n der t he uri ne e xcreti o n rate c ur ve fr o m ti me zer o t o last me as ura ble 
o bser ve d e xcreti o n rate. 
R E C %  
Perc e nta ge of dr u g re c o vere d i n uri ne , calc ulate d f or gi vi n ostat as 1 0 0 ∙
𝐴𝑚𝑡𝐶𝑈 𝑀
D o s e
, a n d f or gi vi n ostat meta b olites as 1 0 0 ∙
𝐴𝑀𝑇𝐶𝑈 𝑀,𝑀𝑒𝑡𝑎𝑏𝑜𝑙𝑖𝑒
𝑀𝑊𝑀𝑒𝑡𝑎𝑏𝑜𝑙𝑖𝑡𝑒
⁄
𝐷𝑜𝑠𝑒𝐺𝑖𝑣𝑖𝑛𝑜𝑠𝑡𝑎𝑡
𝑀𝑊𝐺𝑖𝑣𝑖𝑛𝑜𝑠𝑡𝑎𝑡
⁄
, w here M W re prese nts t he m ole c ular wei g ht 
of t he a nal yte. 
N ote: F or givi n ost at, M W is 4 2 1. 4 9 g/ m ol; f or I T F 2 3 7 4 , M W is 4 0 5. 4 9 
g/ m ol; f or I T F 2 3 7 5, M W is 4 0 6. 4 7 g/ m ol;  f or I T F 2 4 4 0, M W is 2 5 7. 3 3 
g/ m ol; a n d f or I T F 2 5 6 3, M W is 1 7 8. 1 9 g/ m ol . 
C L R / F 
A p pare nt re nal cleara nc e affe cte d b y F, c alc ulate d as 
𝐷𝑜𝑠𝑒
A U R C 0 −t. 
7. 
S T U D Y E N D P OI N T S
7. 1.   
Pri m ar y  
1.
Gi vi n ostat a n d its meta b olites plas ma a n d uri ne c o nce ntrati o ns a n d t here of deri ve d
p har mac o ki netic para meters f oll o wi n g si n gle a n d m ulti ple oral d oses of gi vi n ostat ( Part 3).
7. 2.   
S e c o n d ar y  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 9  of 1 4 3  
1.
I nci de nc e a n d se verit y of A Es; c ha n ges i n vital si g ns, p h ysic al e xa mi nati o n, E C G a n d
cli nic al la b orat or y tests f oll o wi n g a d mi nistrati o n of si n gle - a n d m ulti ple -d oses of gi vi n ostat
( Part 3).
8. 
A N A L Y SI S P O P U L A TI O N S
T he a nal ysis p o p ulati o ns are defi ne d i n ac c or da nce wit h t he C S P [ 1].
F or e a c h st u d y part, t he s u bje cts t o be i ncl u de d i n e ac h a nal ysis p o p ulati o n will be re p orte d i n t he
res pecti ve Data Bli n d Re vie w Pr oc ess  Mi n ute ( A n ne x 5 ).
F or e a c h st u d y part, e x pla nati o n of t he re as o ns f or e xcl usi o n of s u bje cts fr o m a n y a nal ysis
p o p ulati o n will be pr o vi de d i n t he res pe cti ve Data Bli n d Re vie w Pr oc ess  Mi n ute ( A n ne x 5 ) a n d i n
t he C S R.
T he list of s u bje cts w h o c o m plete e ac h st u d y part  will be prese nte d i n A n ne x 6 .
8. 1.   
P art 3  
P art 3 S afet y A n al ysis P o p ul ati o n  
All s u bje cts w h o r ec ei ve at le ast o ne d ose of t he I M P i n P art 3  of t he st u d y will c o nstit ute t he Part 3  
S afet y A nal ysis P o p ulati o n.  
Part 3  safet y data a nal ysis will be perf or me d f or all s u bjects i n t he Part 3  S afet y A nal ysis 
P o p ulati o n.  
P art 3 P h ar m ac o ki n etic A n al ysis P o p ul ati o n  
8. 1. 2. 1.  P art 3 Si n gle -D ose P h ar m ac o ki n etic A n al ysis P o p ul ati o n  
Part 3 Si n gle -D ose P har mac o ki netic A nal ysis P o p ulati o n will i ncl u de all s u bje cts e nr olle d i n Part 3 
of t he st u d y, w h o are e x pe cte d t o pr o vi de e val ua ble p har ma c o ki netic data f or t he gi vi n ostat si n gle -
d ose a d mi nistrati o n ( Da y 1) , wit h o ut de viati o ns affe cti n g p har mac o ki netic i nter pretati o n. 
T he f oll o wi n g reas o ns j ustif y t he e xcl usi o n of t he p har mac o ki netic data of a s u bject fr o m t he Part 3 
si n gle-d ose p har ma c o ki netic  a nal ysis p o p ulati o n : 
- 
Pr ot oc ol vi olati o n c o nsi dere d t o ha ve a p ote ntiall y rele va nt effect o n t he p har ma c o ki netic
res ults of t he st u d y.
N O T E: T h e se  pr ot oc ol vi ol ati o ns  will be re p orte d i n t he D at a Bli n d Re vie w Pr ocess  Mi n ute 
(A n ne x 5 ), a n d t heir i m p act will be assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
- 
S u bje ct e x perie nc e d v o miti n g or diarr hea.
N O T E: S u bjects t h at e x perie nc e d v o miti n g or di arr h oe a d uri n g t h is st u dy p art w ill be 
re p orte d i n t he D at a Bli n d Re vie w Pr oc ess  Mi n ute (A n nex 5 ), a n d t heir ex cl usi o n will be 
assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 0  of 1 4 3  
- 
S u bje ct wit h pre -d ose c o nce ntrati o n > 5 % of t he C ma x  val ue of t he c orres p o n di n g
p har mac o ki netic pr ofile.
N O T E: T his e x cl usi o n will be assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
- 
S u bje ct wit h lac k of a n y me as ura ble c o nc e ntrati o ns or o nl y ver y l o w plas ma  c o nce ntrati o ns.
N O T E: T his e x cl usi o n will be ass esse d at t he ti me of p h ar m ac oki netic a n alysis.  
8. 1. 2. 2.  P art 3 M ulti ple -D ose P h ar m ac o ki netic A n al ysis P o p ul ati o n  
Part 3 M ulti ple -D ose P har mac o ki netic A nal ysis P o p ulati o n will i ncl u de all s u bje cts e nr olle d i n Part 
3 of t he st u d y, w h o are e x pe cte d t o pr o vi de e val ua ble p har ma c o ki netic data f or t he gi vi n ostat 
m ulti ple -d ose a d mi nistrati o n ( Da y 1 3) , wit h o ut de viati o ns affe cti n g p har ma c o ki netic i nter pretati o n. 
T he f oll o wi n g reas o ns j ustif y t he e xcl usi o n of t he p har mac o ki netic data of a s u bject fr o m t he Part 3 
m ulti ple -d ose p har mac o ki netic  a nal ysis p o p ulati o n : 
- 
Pr ot oc ol vi olati o n c o nsi dere d t o ha ve a p ote ntiall y rele va nt effect o n t he p har ma c o ki netic
res ults of t he st u d y.
N O T E: T h e se  pr ot oc ol vi ol ati o ns  will be re p orte d i n t he D at a Bli n d Re vie w Pr ocess  Mi n ute 
(A n ne x 5 ), a n d t heir i m p act will be assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
- 
S u bje ct e x perie nc e d v o miti n g or diarr hea.
N O T E: S u bjects t h at e x perie nc e d v o miti n g or di arr h oe a d uri n g t h is st u dy p art ill be 
re p orte d i n t he D at a Bli n d Re vie w Pr oc ess Mi n ute (A n nex 5 ), a n d t heir ex cl usi o n will be 
assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
- 
S u bje ct wit h lac k of a n y me as ura ble c o nc e ntrati o ns or o nl y ver y l o w plas ma  c o nce ntrati o ns.
N O T E: T his e x cl usi o n will be assesse d at t he ti me of p h ar m ac oki netic a n alysis.  
9. 
D A T A R E VI E W / T R A N S F O R M A TI O N
9. 1.   
D at a M a n a ge me nt  
Data ha n dli n g will be c o n d ucte d i n ac c or da nc e wit h t he Cli nic al Data Ma na ge me nt secti o n of t he 
C S P a n d t he Data Ma na ge me nt Pla n de vel o pe d s pecific all y f or t his st u d y.   
9. 2.   
Ac ce pt a nc e of D at a  
F or e a c h st u d y part, T F Ls ma y start bei n g pr o gra m me d pri or t o or d uri n g t he c o urse of t he trial. 
H o we ver, t he pr o gra m mi n g of a nal ysis da tasets a n d T F Ls will o nl y be c o ncl u de d a n d q ualit y-
c o ntr olle d after data base s oft l oc k. O nl y a u dite d data release d b y t he bi oa nal ytic al la b orat or y will be 
use d f or pr o gra m mi n g t he fi nal a nal ysis datasets a n d T F Ls.    
9. 3.   
D at a Tr a nsf or m ati o n ( C DI S C)  
Bef ore pe rf or mi n g t he statistic al a nal ysis, all data c olle cte d ( m ulti ple s o urc es) will be i nte grate d i nt o 
a c o m m o n re p osit or y, usi n g S A S ®  versi o n 9. 4 or hi g her .  
F or sta n dar dizati o n a n d s u b missi o n p ur p ose, all data will be tra nsf or me d ac c or di n g t o Cli nic al Data 
I nterc ha n ge Sta n dar ds C o ns orti u m ( C DI S C):  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 1  of 1 4 3  
- 
St u d y Data Ta b ulati o n M o del ( S D T M) versi o n 1. 4  or hi g her .
- 
S D T M  I m ple me ntati o n G ui de ( S D T MI G) versi o n 3. 2 or hi g her .
- 
T he f oll o wi n g a nal ysis datasets will be ge nerate d ( A nal ysis Data M o del [ A Da M] versi o n
2. 1  or hi g her ; A Da M I m ple me ntati o n G ui de [ A Da MI G], versi o n 1.2  or hi g her ) t o s u p p ort
t he res ults a n d ease t he pr o gra m mi n g a cti vities d uri n g t he statistic al a nal ysis:
- 
S u bje ct -Le vel A nal ysis Dataset ( A D S L).
- 
A nal ysis Data P har ma c o ki netic C o nce ntrati o ns ( A D P C) .
- 
A nal ysis D ata P har ma c o ki netic Para meters ( A D P P) .
- 
A nal ysis Data A d verse E ve nts ( A D A E).
- 
A nal ysis Data Vital Si g ns ( A D V S).
- 
A nal ysis Data Electr ocar di o gra m Para meters ( A D E G).
- 
A nal ysis Data La b orat or y Test Res ults ( A D L B).
F or t he sc o pe of t his trial, c o nsi deri n g t he pri mar y a n d sec o n dar y o bje cti ves, si x (6 ) Basic Data 
Str uct ure ( B D S) d o mai ns will be ge nerate d: A D P C, A D P P, A D A E, A D V S , A D E G a n d A D L B . 
T hese si x datasets pl us A D S L will be u p date d f or e ac h part.  T hese d o mai ns will s u p p ort t he 
descri pti ve statistic al a nal yses of t he p har mac o ki netic c o nc e ntrati o ns , t he p har mac o ki netic 
para meters  a n d safet y.  
A D S L –  S u bje ct -Le vel A nal ysis Dataset  
T his a nal y sis d o mai n will c o ntai n: ge neral data a b o ut t he s u bje cts (i.e., a ge, se x a n d rac e), pla n ne d 
a n d a ct ual all oc ate d treat me nt  a nal ysis, a n d start a n d e n d dates of tre at me nt a nal ysis peri o d. T he 
ori gi n of t hese data will pri maril y be t he De m o gra p hics ( D M) a n d E x p os ure ( E X) S D T M d o mai ns. 
Besi des t his i nf or mati o n, t he f oll o wi n g varia bles will be deri ve d:  
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 3  –  S u bje cts i ncl u de d i n t he Part 3  Si n gle -
D ose P har mac o ki netic A nal ysis P o p ulati o n.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 4  –  S u bje cts i ncl u de d i n t he Part 3  M ulti ple -
D ose P har mac o ki netic A nal ysis P o p ulati o n.
- 
C o m pleters P o p ul ati o n Fl a g  –  S u bje cts w h o c o m plete d t he treat me nt p eri o d.
A D P C –  A nal ysis Data P har mac o ki netic C o nce ntrati o ns  
T his is a B D S dataset t hat will c o ntai n t he c o nce ntrati o ns f or ea c h s u bject, per tre at me nt  a nal ysis, 
per a nal yte/ meta b olite,  a n d per ti me p oi nt.  
T he ori gi n of t hese data will pri maril y be t he E X a n d P har ma c o ki netic C o nce ntrati o ns ( P C) S D T M 
d o mai ns a n d A D S L A Da M d o mai n.  
Besi des t his i nf or mati o n, t he f oll o wi n g varia bles will be deri ve d:  
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 1.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 1
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 2
- 
Dr u g -Dr u g I nter acti o n A n alysis Set  P o p ul ati o n Fl a g 3.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 4.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 5.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 6.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 2.
- 
Dr u g -Dr u g I nter acti o n A n a lysis Set P o p ul ati o n Fl a g 7.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 3.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 4 .
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 2  of 1 4 3  
A D P P –  A nal ysis Data P har mac o ki netic Para meters  
T his is a B D S dataset t hat will c o ntai n t he N C A p har ma c o ki netic para meters ( plas ma a n d uri ne) f or 
e a c h s u bje ct , per treat me nt  a nal ysis a n d per a nal yte/ meta b olite . 
Besi des t he ori gi nal p har ma c o ki netic para meter val ue, t he dataset will c o ntai n t he l n-tra nsf or me d 
val ue t hat is necessar y t o a p pl y f or t he s pe cifie d statistic al m o del(s).  
T he ori gi n of t hese data will pri maril y be t he D M a n d P har ma c o ki netic Para meters ( P P)  S D T M 
d o mai ns.  
Besi des t his i nf or mati o n, t he f oll o wi n g varia bles will be deri ve d:  
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 1.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 1.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 2.
- 
Dr u g -Dr u g I nter ac ti o n A n alysis Set P o p ul ati o n Fl a g 3.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 4.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 5.
- 
Dr u g -Dr u g I nter acti o n A n alysis Set P o p ul ati o n Fl a g 6.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 2.
- 
Dr u g -Dr u g  I nter acti o n A n alysis Set P o p ul ati o n Fl a g 7.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 3.
- 
P h ar m ac oki netic A n alysis Set P o p ul ati o n Fl a g 4 .
A D A E –  A nal ysis Data A d verse E ve nts Dataset  
T his is a n O C C D S dataset t hat will c o ntai n t he a d verse e ve nts f or ea c h s u bject.  
T he ori gi n of t hese data will pri maril y be t he A d verse E ve nts ( A E) S D T M d o mai n a n d A D S L 
A Da M d o mai n.  
A D V S –  A nal ysis Data Vital Si g ns Dataset  
T his is a B D S dataset t hat will c o ntai n t he vital si g ns res ults f or e ac h s u bje ct, per treat me nt  a nal ysis 
a n d per ti me p oi nt.  
T he ori gi n of t hese data will pri maril y be t he Vital Si g ns ( V S) S D T M d o mai n a n d A D S L A Da M 
d o mai n.  
A D E G –  A nal ysis Data Electr ocar di o gra m Para meters Dataset  
T his i s a B D S dataset t hat will c o ntai n t he electr ocar di o gra m f or ea c h s u bject, per treat me nt  a nal ysis 
a n d per ti me p oi nt.  
T he ori gi n of t hese data will pri maril y be t he E C G Test Res ults ( E G) S D T M d o mai n a n d A D S L 
A Da M d o mai n.  
A D L B –  A nal ysis Data La b orat or y Test Res ults Dataset  
T his is a B D S dataset t hat will c o ntai n t he safet y la b orat or y test res ults f or e a c h s u bje ct  a n d per 
tre at me nt a nal ysis.  
T he ori gi n of t hese data will pri maril y be t he La b orat or y Test Res ults ( L B) S D T M d o mai n a n d 
A D S L A Da M d o mai n.  
1 0. 
S T A TI S TI C A L M E T H O D S
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 3  of 1 4 3  
1 0. 1.   
Ge n er al C o nsi de r ati o ns  
Esti mati o n of t he p har ma c o ki netic para meters a n d dr u g -dr u g i nteracti o n c o m parati ve bi oa vaila bilit y  
a nal ysis will be c o n d ucte d o n P h oe ni x ®  Wi n N o nli n
®  versi o n  8. 2 or hi g her ( Certara U S A I nc, 
Pri nc et o n, NJ) . All ot her statistic al a nal ysis will be c o n d ucte d o n S A S®  versi o n 9. 4 or hi g her.  
Statistic al a nal yses a n d p har ma c o ki netic a nal yses will be perf or me d i n a cc or da nce wit h  t he U. S. 
F D A  g ui da nc es  [ 2, 3] a n d 
 a p plic a ble Sta n dar d O perati n g Pr oc e d ures ( S O Ps). 
U nless s pecifie d ot her wise, c o nti n u o us varia bles will be s u m marize d wit h t he f oll o wi n g descri pti ve 
statistics: n u m ber o f o bser vati o ns (n ), me a n, sta n dar d de viati o n ( S D), mi ni m u m, me dia n a n d 
ma xi m u m val ue s. Cate g orical data will be s u m marize d wit h fre q ue ncies a n d perc e nta ges. 
F or s u bje ct s’ c haracteristics a n d safet y a nal yses, missi n g data will n ot be re pla ce d; descri pti ve 
statistics a n d statistic al a nal ysis will be perf or me d base d o n t he a vaila ble data o nl y. All data 
re c or de d o n disc o nti n ue d s u bjects will be liste d.  
1 0. 2.   
S u bjects’ Dis p ositi o n  
T he n u m ber of s u bje cts w h o c o m plete d ea c h st u d y part as well as s u bje cts w h o wit h dre w 
pre mat urel y fr o m t he st u d y will be s u m marize d b y c o m pleti o n stat us a n d reas o n f or wit h dra wal. 
S u bje cts w h o pre mat urel y wit h dre w fr o m t he st u d y will be liste d.  
T he n u m ber of s u bje cts i ncl u de d i n e a c h a nal ysis p o p ulati o n wil l be s u m marize d, f or ea c h st u d y 
part . 
1 0. 3.   
Pr ot oc ol De vi ati o ns  
D uri n g t he res pe cti ve Data Bli n d Re vie w Pr ocess, all pr ot oc ol de viati o ns t hat oc c urre d d uri n g ea c h 
st u d y part will be assesse d i n ter ms of t heir p ote ntial i m pa ct o n t he p har ma c o ki netic a nal ysis. T he 
res ult of t his assess me nt will be re p orte d i n t he res pecti ve Data Bli n d Re vie w Pr ocess  Mi n ute 
(A n ne x 1 , A n ne x 3 , a n d A n ne x 5 ). 
1 0. 4.   
Pl as m a  P h ar m ac o ki n etic C o n ce ntr ati o ns  
F or e a c h st u d y part  ( Part 1, Part 2 a n d Part 3), f or t he s u bje cts i ncl u de d i n t he res pecti ve 
p har mac o ki netic a nal ysis p o p ulati o n, descri pti ve statistics [ n , ge o metric me a n ( Gmea n ), arit h metic 
me a n  ( Amea n ), S D, ge o metric S D  ( G S D), c oefficie nt of variati o n ( C V %), ge o metric C V %  ( G C V %), 
t w o-si de d 9 5 % CI of t he A mea n  a n d G mea n , me dia n, mi ni m u m a n d ma xi m u m] of t he plas ma  
c o nc e ntrati o ns will be prese nte d f or ea c h ti me p oi nt, b y a nal yte, a n d b y a d mi nistrati o n da y . 
C o nc e ntrati o ns bel o w t he L L O Q will be ta ke n as missi n g f or t he calc ula ti o n of t he l o g-tra nsf or me d 
statistics a n d as zer o f or t he c alc ulati o n of t he re mai ni n g s u m mar y statistics.  
A d diti o nall y, f or Part 3, f or t he s u bjects i ncl u de d i n t he res pecti ve p har ma c o ki netic a nal ysis 
p o p ulati o n, descri pti ve statistics of t he c o nc e ntrat i o ns of gi vi n ostat a n d its meta b olites i n plas ma 
will be prese nte d b y si n gle a n d m ulti ple -d ose, a n d b y se x.  
Ac hie ve me nt of ste a d y -state c o n diti o ns will be deter mi ne d b y vis ual i ns pecti o n of t he tr o u g h plas ma 
c o nc e ntrati o n -ti me pr ofile ( Ctr o u g h). A nal ysis of varia nc e of t he plas ma C tr o u g h ma y be perf or me d if 
c o nsi dere d a p pr o priate. 
P P D
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 4  of 1 4 3  
F or e a c h st u d y part  ( Part 1, Part 2 a n d Part 3), in di vi d ual ( per s u bject) a n d G mea n  (i ncl u di n g 9 5 % 
CIs) plas ma  c o nc e ntrati o n v ers us ti me pr ofile will be gra p hic all y displa ye d i n b ot h li ne ar a n d se mi -
l o garit h mic scales: 
- 
F or pl otti n g i n di vi d ual data i n li ne ar scale, c o nc e ntrati o ns bel o w t he L L O Q will be
s u bstit ute d b y zer o.
- 
F or pl otti n g G mea n  data i n li ne ar scale, c o nc e ntrati o ns bel o w t he L L O Q will be s u bstit ute d
b y missi n g.
- 
F or pl otti n g data i n se mi -l o garit h mic scale, c o nc e ntrati o ns bel o w t he L L O Q bef ore t ma x ,
will be s u bstit ute d b y ½ of t he L L O Q val ue. After t ma x , c o nc e ntrati o ns bel o w t he L L O Q
will be c o nsi dere d as missi n g . H o we ver, i n c ase of t w o or m ore c o nsec uti ve c o nc e ntrati o ns
bel o w t he L L O Q, t he first val ue will be re pla ce d b y ½ of t he L L O Q val ue a n d t he ne xt
val ues will be c o nsi dere d as missi n g.
Gra p hic prese ntati o n of i n di vi d ual data will be base d o n act ual bl o o d s a m pli n g ti me, e xc e pt f or pre -
d ose sa m pli n g ti me w hic h will be ass u me d as t 0. 
C o nc e ntrati o n data fr o m n o n -e val ua ble peri o ds will be liste d a n d gra p hic all y re prese nte d se paratel y. 
1 0. 5.   
Pl as m a P h ar m ac o ki n etic P ar a meters  
F or e a c h st u d y part, plas ma p har ma c o ki net ic para meters will be c alc ulate d f or t he res pe cti ve 
p har mac o ki netic a nal ysis p o p ulati o n.  
F or e a c h st u d y part, f or t he s u bje cts i ncl u de d i n t he p har ma c o ki netic a nal ysis p o p ulati o n, i n di vi d ual 
plas ma p har mac o ki netic para meters a n d descri pti ve statistics  ( n, Gmea n , Ame a n , S D, G S D, C V %, 
G C V %,  t w o-si de d 9 5 % CI of t he A mea n  a n d G mea n , me dia n, mi ni m u m a n d ma xi m u m) , will be 
prese nte d b y i n vesti gati o nal pr o d uct.  
If a gi ve n p har mac o ki netic para meter c o ul d n ot be relia bl y deter mi ne d f or m ore t ha n ⅓ of t he 
s u bje cts, o nl y t he mi ni m u m a n d ma xi m u m val ues will be prese nte d, a n d t he ot her descri pti ve 
statistics will be o mitte d f or t hat para meter.  
Missi n g p har ma c o ki netic para meter data will n ot be i m p ute d.  
F or Part 3, f or t he s u bjects i ncl u de d i n t he res pecti ve p har ma c o ki netic a nal ysis p o p ulati o n, 
descri pti ve statistics of t he plas ma p har mac o ki netic para meters of gi vi n ostat a n d its meta b olites will 
be prese nte d b y si n gle a n d m ulti ple -d ose, a n d b y se x.  
F or Part 3, t i me de pe n de nc y will be e x pl ore d b y c o m pari n g A U C 0 -τ,ss deri ve d fr o m t he last d osi n g 
da y ( Da y 1 3), after m ulti ple d oses a d mi nistrati o n, wit h A U C 0 -∞ deri ve d fr o m t he first d osi n g da y 
( Da y 1), after a si n gle d ose a d mi nistrati o n. Assess me nt of li ne arit y will c o nsi der w het her differe nces 
i n A U C me et a criteri o n of ± 2 5 %. 
F or Part 3, t he Ac c u m ulati o n I n de x f or C ma x  will be deri ve d as t he rati o 
𝑙𝑛𝐷𝑜 ,𝑠𝑒
𝐷𝑜𝑠𝑒 a n d f or A U C it will 
be deri ve d as t he rati o 
𝑖𝑜𝑛0 −𝑉,𝑜𝑙
𝑢𝑚𝑒0 −𝐴. Acc u m ulati o n In de x esti mates will be s u m marize d usi n g A mea n , S D, 
S E me dia n, mi ni m u m  a n d ma xi m u m.  
F or Part 3, meta b olic rati os will be calc ulate d f or e ac h meta b olite as 1 0 0 ∙
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 5  of 1 4 3  
𝑙𝑛𝐷0 −∞ ,𝑜𝑠𝑒𝐷𝑜𝑠𝑒𝑖𝑜
𝑛𝑉𝑜𝑙𝑢𝑚𝑒𝐴𝑚𝑡𝐶𝑈
⁄
𝑀𝐴𝑀0 −∞ ,𝑇𝐶𝑈𝑀𝑀𝑒𝑡𝑎𝑏𝑜
𝑙𝑖𝑒𝑀𝑊𝑀𝑒𝑡𝑎𝑏𝑜𝑙
⁄
, f or Da y 1 (si n gle-d ose) , a n d as 1 0 0 ∙
𝑖𝑡𝑒0 −τ ,𝐷𝑜𝑠𝑒𝐺𝑖𝑣𝑖𝑛
𝑜𝑠𝑡𝑎𝑡𝑀𝑊𝐺𝑖𝑣𝑖𝑛
⁄
𝑜𝑠𝑡0 −τ ,𝑎𝑡𝐷𝑜𝑠𝑒𝑠𝑡𝑎𝑡
𝑀𝑊𝐺𝑖𝑣𝑖𝑛𝑜𝑠𝑡𝑎𝑡
⁄
, f or 
Da y 1 3  (m ulti ple -d ose) . 
N ote: M W re prese nts t he m olec ul ar wei g ht of t he a n alyte. F or givi n ost at, M W is 4 2 1. 4 9 g/ m ol; f or 
I T F 2 3 7 4, M W is 4 0 5. 4 9 g/ m ol; f or I T F 2 3 7 5, M W is 4 0 6. 4 7 g/ m ol; f or I T F 2 4 4 0, M W is 2 5 7. 3 3 
g/ m ol; a n d f or I T F 2 5 6 3, M W is 1 7 8. 1 9 g/ m ol.  
1 0. 6.   
Uri n ar y  D at a  
F or Part 3, f or t he s u bjects i ncl u de d i n t he p har ma c o ki netic a nal ysis p o p ulati o n, descri pti ve statistics 
( n, Gmea n , Amea n , S D, G S D, C V %, G C V %, t w o-si de d 9 5 % CI of t he A mea n  a n d G me a n , me dia n, 
mi ni m u m a n d ma xi m u m)  of t h e  uri nar y e xcreti o n pr ofile  a n d uri nar y c u m ulati ve e xcreti o n pr ofile  
will be prese nte d f or e ac h c ollecti o n i nter val , b y a nal yte, b y si n gle ( Da y 1) a n d m ulti ple  ( Da y 1 3) 
d ose , a n d b y se x. C o nce ntrati o ns bel o w t he L L O Q will be ta ke n as missi n g f or t he c alc ulati o n of t he 
l o g-tra nsf or me d statistics a n d as zer o f or t he c alc ulati o n of t he re mai ni n g s u m mar y statistics.  
I n di vi d ual ( per s u bje ct) a n d Gmea n  uri nar y e xcreti o n v ers us ti me pr ofile a n d uri nar y c u m ulati ve 
e xcreti o n v ers us ti me pr ofile will be gra p hicall y dis pla ye d , i n b ot h li ne ar a n d se mi-l o garit h mic 
scales: 
- 
F or pl otti n g i n di vi d ual data i n li ne ar scale, a m o u nts bel o w t he L L O Q will be s u bstit ute d b y
zer o.
- 
F or pl otti n g G mea n  data i n li ne ar scale, a m o u nts bel o w t he L L O Q will be s u bstit ute d b y
missi n g.
Da y -1 sa m pli n g will be ass u me d as t 0. 
1 0. 7.   
Uri n ar y P h ar m ac o ki netic P ar a mete rs  
F or Part 3 , uri nar y p har ma c o ki netic para meters will be calc ulate d f or t he res pe cti ve p har mac o ki netic 
a nal ysis p o p ulati o n.  
F or Part 3 , f or t he s u bjects i ncl u de d i n t he p har ma c o ki netic a nal ysis p o p ulati o n, i n di vi d ual uri nar y 
p har mac o ki netic para meters a n d descri pti ve statistics ( n, G mea n , Ame a n , S D, G S D, C V %, G C V %, 
t w o-si de d 9 5 % CI of t he A mea n  a n d G mea n , me dia n, mi ni m u m a n d ma xi m u m), will be prese nte d b y 
a nal yte, b y si n gle a n d m ulti ple -d ose, a n d b y se x . 
If a gi ve n p har mac o ki netic para meter c o ul d n ot be relia bl y deter mi ne d f or m ore t ha n ⅓ of t he 
s u bje cts, o nl y t he mi ni m u m a n d ma xi m u m val ues will be prese nte d, a n d t he ot her descri pti ve 
statistics will be o mitte d f or t hat para meter.  
Missi n g p har ma c o ki netic para meter data will n ot be i m p ute d.  
1 1. 
P R E S E N T A TI O N O F R E S U L T S
1 1. 1.   
St atistic al O ut p ut S pe cific ati o n  
Ta bles will be ge nerate d as Ric h Te xt Files ( *.rtf) fr o m S A S ® . 
Fi g ures a n d A nal ysis O ut p uts will be ge nerate d as *. d oc x files, e x p orte d fr o m P h oe ni x Wi n N o nli n ®  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 6  of 1 4 3  
a n d/ or S A S ® . 
I n-te xt Ta bles a n d Fi g ures will prefera bl y be pre pare d i n p ortrait f or mat. Listi n gs will prefera bl y be 
pre pare d i n la n dsca pe f or mat . 
T he C S R will be writte n ac c or di n g t o 
S O Ps a n d te m plates f or re p orti n g 
bi oa vaila bilit y/ bi oe q ui vale nc e trials.  
1 1. 2.   
Pl a n n e d T a bles, Fi g u res, a n d S u bje ct D at a Listi n gs  
T he pla n ne d T a bles, F i g ures, a n d In di vi d ual D ata L isti n gs f or t he C S R are liste d bel o w. 
I n-te xt T a bles a n d Fi g u res 
F or C S R S y n o psis: 
T he f oll o wi n g Ta bles will be pr o d uce d f or dire ct i nserti o n i n t he S y n o psis of t he C S R:  
Title  
P A R T 3  
Gi vi n ostat a n d Its Mai n Meta b olites (I T F 2 3 7 4 a n d I T F 2 3 7 5,): S u m mar y Statistics of t he Plas ma 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
Gi vi n ostat Meta b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m mar y Statistics of t he Plas ma 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
Gi vi n ostat a n d Its Mai n Meta b olites (I T F 2 3 7 4 a n d I T F 2 3 7 5,): S u m mar y Statistics of t he Plas ma 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
Gi vi n ostat Meta b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m mar y Statistics of t he Plas ma 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
Gi vi n ostat a n d Its Mai n Meta b olites (I T F 2 3 7 4 a n d I T F 2 3 7 5): S u m mar y Statistics of t he Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
Gi vi n ostat Meta b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m mar y Statistics of t he Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
Gi vi n ostat a n d Its Mai n Meta b olites (I T F 2 3 7 4 a n d I T F 2 3 7 5): S u m mar y Statistics of t he Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
Gi vi n ostat Meta b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m mar y Statistics of t he Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
T he f oll o wi n g  Fi g ures will be pr o d uce d f or direct i nserti o n i n t he S y n o psis of t he C S R:  
Le ge n d  
P A R T 3  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g 
Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat. A –  Li near 
P P D
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 7  of 1 4 3  
Le ge n d  
S c ale; B –  S e mi -L o garit h mic Sc ale  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g S i n gle-D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat ( Da y 1). A –  Li ne ar S cale; B –  Se mi -L o garit h mic S c ale  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1 ) a n d M ulti ple-D ose ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat ( Da y 1). A –  Li ne ar S cale; B –  Se mi -L o garit h mic S c ale  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D o se ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat ( Da y 1). A –  Li ne ar S cale; B –  Se mi -L o garit h mic S c ale  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat ( Da y 1). A –  Li ne ar S cale; B –  Se mi -L o garit h mic S c ale  
F or C S R B o d y Te xt: 
T he f oll o wi n g Ta bles a n d Fi g ures will be pr o d uc e d f or dire ct i nserti o n i n t he b o d y te xt of t he C S R:  
I n-te xt T a bles  
Title  
P A R T 3  
Ta ble 3. A.   
St u d y Fl o w -C hart –  Part 3  
Ta ble 3. B.   
I de ntit y of I n vesti gati o nal Pr o d ucts –  Part 3  
Ta ble 3. C.   
S u m mar y of S u bje cts Dis p ositi o n –  Part 3  
Ta ble 3. D.   
S u m mar y of De m o gra p hic Data of t he P har ma c o ki netic A nal ysis P o p ulati o ns  
Ta ble 3. E.   
Gi vi n ostat a n d Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): 
S u m mar y Statistics of t he Plas ma P har mac o ki netic Para meters F oll o wi n g 
Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
Ta ble 3. F.   
Gi vi n o stat a n d Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): 
S u m mar y Statistics of t he Plas ma P har mac o ki netic Para meters F oll o wi n g 
M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
Ta ble 3. G.   
Gi vi n ostat a n d Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): 
S u m mar y Statistics of t he Plas ma P har mac o ki netic Para meters Ac c u m ulati o n 
I n de x 
Ta ble 3. H.   
Gi vi n ostat a n d Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): 
S u m mar y Statistics of t he Uri nar y P har mac o ki netic Para meters F oll o wi n g 
Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  2 1 
Ta ble 3.I.   
Gi vi n ostat a n d Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): 
S u m mar y Statistics of t he Uri nar y P har mac o ki netic Para meters F oll o wi n g 
M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  2 1 
Ta ble 3.J.   
S u m mar y of Treat me nt -E mer ge nt A d verse E ve nts ( T E A Es)  
I n-te xt Fi g ur es 
Le ge n d  
P A R T 3  
Fi g ure 3. A. 1.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3. A. 2.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 8  of 1 4 3  
I n-te xt Fi g ur es 
Le ge n d  
A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic S c ale  
Fi g ure 3. A. 3.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9  t o Da y 
1 3) –  Li near Sc ale
Fi g ure 3. A. 4.   
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Plas ma C o nc e ntrati o n Vers us  Ti me 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9  t o Da y 
1 3) –  S e mi -L o garit h mic Sc ale
Fi g ure 3. A. 5.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) Tr o u g h Plas ma C o nc e ntrati o n V ers us 
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9  
t o Da y 1 3) –  Li near S c ale  
Fi g ure 3. B. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li ne ar S cale  
Fi g ure 3. B. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metri c Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic 
S c ale  
Fi g ure 3. B. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. B. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Se mi -L o garit h mic S cale  
Fi g ure 3. B. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) Tr o u g h Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. C. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofi le F oll o wi n g Si n gle-D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li ne ar S cale  
Fi g ure 3. C. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ult i ple-D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic 
S c ale  
Fi g ure 3. C. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. C. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Se mi -L o garit h mic S cale  
Fi g ure 3. C. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) Tr o u g h Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale 
Fi g ure 3. D. 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li ne ar S cale  
Fi g ure 3. D. 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  2 9  of 1 4 3  
I n-te xt Fi g ur es 
Le ge n d  
S c ale  
Fi g ure 3. D. 3.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. D. 4.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Se mi -L o garit h mic S cale  
Fi g ure 3. D. 5.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) Tr o u g h Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. E. 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li ne ar S cale  
Fi g ure 3. E. 2.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metri c Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d 
M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic 
S c ale  
Fi g ure 3. E. 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. E. 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Se mi -L o garit h mic S cale  
Fi g ure 3. E. 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) Tr o u g h Plas ma 
C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n 
of Gi vi n ostat ( Da y 9  t o Da y 1 3) –  Li near S cale  
Fi g ure 3. F. 1.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) of Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3. F. 2.  
Gi vi n ostat: Ge o metric Mea n ( 9 5 % CI) of C u m ulati ve A m o u nt Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3. G. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metric Mea n ( 9 5 % CI) of Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3. G. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Ge o metri c Mea n ( 9 5 % CI) of C u m ulati ve 
A m o u nt Uri nar y E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 
1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near S cale
Fi g ure 3. H. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) of Uri n ar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3. H. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Ge o metric Mea n ( 9 5 % CI) of C u m ulati ve 
A m o u nt Uri nar y E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 
1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near S cale
Fi g ure 3.I. 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) of Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3.I. 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Ge o metric Mea n ( 9 5 % CI) of C u m ulati ve 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 0  of 1 4 3  
I n-te xt Fi g ur es 
Le ge n d  
A m o u nt Uri nar y E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 
1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near S cale
Fi g ure 3.J. 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) of Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
Fi g ure 3.J. 2.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Ge o metric Mea n ( 9 5 % CI) of C u m ulati ve 
A m o u nt Uri nar y E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 
1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near S cale
T a bles, Fi g u res a n d Gr a p hs Refer re d t o B ut N ot I ncl u d e d i n t h e Te xt ( S e cti o n 1 4 of C S R)  
At le ast t he f oll o wi n g Ta bles a n d Fi g ures s h o ul d be pr o d uc e d f or Se cti o n 1 4 of t he C S R.  
If ne c essar y, a d diti o nal Ta bles a n d Fi g ures s h o ul d be pre pare d. 
T he f oll o wi n g Ta bles a n d Fi g ures will be c o m pile d i n a d oc u me nt, t o be c o nsi dere d as S ecti o n 1 4 
( Ta bles, Fi g ures a n d Gra p h Referre d T o B ut N ot I ncl u de d i n t he Te xt) of t he C S R. 
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. P A R T 3  
1 4. 3. 1. D E M O G R A P HI C D A T A –  P A R T 3  
1 4. 3. 1. 1.  
De m o gr a p hic D at a –  P art 3 S afet y A n al ysis P o p ul ati o n  
1 4. 3. 1. 2.  
De m o gr a p hic D at a –  P art 3 Si n gle -D ose P h ar m ac o ki netic A n al ysis 
P o p ul ati o n  
1 4. 3. 1. 3 .  
De m o gr a p hic D at a –  P art 3 M ulti ple -D ose P h ar m ac o ki n etic A n al ysis 
P o p ul ati o n  
1 4. 3. 1. 4 .  
S u bjects Pr e m at ur el y Disc o nti n ue d Afte r First D osi n g  
1 4. 3. 2. P H A R M A C O KI N E TI C D A T A –  P A R T 3  
1 4. 3. 2. 1.  
Pl as m a P h ar m ac o ki n etic D at a  
1 4. 3. 2. 1. 1.  
De viati o ns fr o m Bl o o d S a m pli n g Sc he d ule  
1 4. 3. 2. 1. 1. 1.  
De viati o ns fr o m Bl o o d S a m pli n g Sc he d ule  
1 4. 3. 2. 1. 1. 2.  
Missi n g Bl o o d S a m ples  
1 4. 3. 2. 1. 1. 3.  
Ot her I m p orta nt Pr ot oc ol De viati o ns  
1 4. 3. 2. 1. 2.  
Plas ma C o nc e ntrati o ns  
1 4. 3. 2. 1. 2. 1.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 2. 2.   
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) 
– Male S u bjects
1 4. 3. 2. 1. 2. 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) 
– Fe male S u bjects
1 4. 3. 2. 1. 2. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n os tat ( Da y 1) 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 1  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 1. 2. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 2. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n d i vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 2. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 2. 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 2. 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 2. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 2. 1 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g S i n gle-D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 2. 1 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjec ts 
1 4. 3. 2. 1. 2. 1 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 2. 1 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 2. 1 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g Si n gl e -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 2. 1 6.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 
t o Da y 1 3) 
1 4. 3. 2. 1. 2. 1 7.  
Gi vi n osta t: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 
t o Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 1. 2. 1 8.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 
t o Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 1. 2. 1 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistra ti o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 2  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 1. 2. 2 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Male S u bje cts  
1 4. 3. 2. 1. 2. 2 1 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Fe male S u bje cts  
1 4. 3. 2. 1. 2. 2 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Da ta a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3)  
1 4. 3. 2. 1. 2. 2 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M u lti ple-D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Male S u bje cts  
1 4. 3. 2. 1. 2. 2 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Fe male S u bje cts  
1 4. 3. 2. 1. 2. 2 5.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3)  
1 4. 3. 2. 1. 2. 2 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Male S u bje cts  
1 4. 3. 2. 1. 2. 2 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Fe male S u bje cts  
1 4. 3. 2. 1. 2. 2 8.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3)  
1 4. 3. 2. 1. 2. 2 9.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat  ( Da y 9 t o Da y 1 3) –  Male S u bje cts  
1 4. 3. 2. 1. 2. 3 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma C o nc e ntrati o ns F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Fe male S u bje cts  
1 4. 3. 2. 1. 3.  
Plas ma P har ma c o ki netic Para meters  
1 4. 3. 2. 1. 3. 1.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 3. 2.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 3. 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 3  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 1. 3. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 3. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 3. 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 3. 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 3. 1 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 3. 1 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 1 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 3. 1 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 1. 3. 1 5 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 1 6. 
Pl as m a M et a b olic R ati o s f or Givi n ost at M et a b olit es (I TF 2 3 7 4, I T F 2 3 7 5, 
I TF 2 4 4 0 a n d I TF 2 5 6 3) F oll o wi n g Si n gl e-D os e A d mi nistr ati o n of Givi n ost at 
( D ay 1) 
1 4. 3. 2. 1. 3. 1 7.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 3. 1 8.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 1. 3. 1 9.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Plas ma 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 4  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 1. 3. 2 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve St atistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 3. 2 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 1. 3. 2 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 2 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 3. 2 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 1. 3. 2 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Stati stics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 2 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F ol l o wi n g M ulti pl e-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 3. 2 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Mal e S u bjects 
1 4. 3. 2. 1. 3. 2 8.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 2 9.  
Gi vi n ostat Meta b ol ite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 3. 3 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Pla s ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 1. 3. 3 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Plas ma P har ma c o ki netic Para meters F oll o wi n g M ulti pl e -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 3 2.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Ac c u m ulati o n I n de x  
1 4. 3. 2. 1. 3. 3 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Ac c u m ul ati o n I n de x 
– Male S u bjects
1 4. 3. 2. 1. 3. 3 4.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Ac c u m ulati o n I n de x 
– Fe male S u bjects
1 4. 3. 2. 1. 3. 3 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x  
1 4. 3. 2. 1. 3. 3 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Male S u bjects  
1 4. 3. 2. 1. 3. 3 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Fe male S u bjects  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 5  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 1. 3. 3 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x  
1 4. 3. 2. 1. 3. 3 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Male S u bjects  
1 4. 3. 2. 1. 3. 4 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 4 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statis tics 
of Acc u m ulati o n I n de x  
1 4. 3. 2. 1. 3. 4 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Male S u bjects  
1 4. 3. 2. 1. 3. 4 3.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Ac c u m ulati o n I n de x –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 4 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x  
1 4. 3. 2. 1. 3. 4 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Male S u bjects  
1 4. 3. 2. 1. 3. 4 6 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Acc u m ulati o n I n de x –  Fe male S u bjects  
1 4. 3. 2. 1. 3. 4 7 .  
Plas ma Meta b olic Rati o s f or Gi vi n ostat Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, 
I T F 2 4 4 0 a n d I T F 2 5 6 3) F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3 ) 
1 4. 3. 2. 1. 4.   
L o g -Li near Re gressi o n Para meters f or λ z Esti mati o n  
1 4. 3. 2. 1. 4. 1.   
Gi vi n ostat: L o g -Li near Re gressi o n Para meters f o r λz Esti mati o n F oll o wi n g 
Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 1.   
Gi vi n ostat: L o g -Li near Re gressi o n Para meters f or λ z Esti mati o n F oll o wi n g 
Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 2.   
Gi vi n ostat Meta b olite (I T F 2 3 7 4) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 3.   
Gi vi n ostat Meta b olite (I T F 2 3 7 5) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 4.   
Gi vi n ostat Meta b olite (I T F 2 4 4 0) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 5.   
Gi vi n ostat M eta b olite (I T F 2 5 6 3) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 1. 4. 6.   
Gi vi n ostat: L o g -Li near Re gressi o n Para meters f or λ z Esti mati o n F oll o wi n g 
M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 4. 7.   
Gi vi n ostat Meta b olite (I T F 2 3 7 4) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 4. 8.   
Gi vi n ostat Meta b olite (I T F 2 3 7 5) : L o g-Li near Re gressi o n Para meters  f or λz 
Esti mati o n F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 4. 9.   
Gi vi n ostat Meta b olite (I T F 2 4 4 0) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 1. 4. 1 0.   
Gi vi n ostat Meta b olite (I T F 2 5 6 3) : L o g-Li near Re gressi o n Para meters f or λ z 
Esti mati o n F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2.  
Uri n ar y P h ar m ac o ki netic D at a  
1 4. 3. 2. 2. 1.  
De viati o ns fr o m Uri ne Sa m pli n g S c he d ule  
1 4. 3. 2. 2. 1. 1.  
Missi n g Uri ne S a m ples  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 6  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 2.  
Uri nar y E xcreti o n Pr ofile  
1 4. 3. 2. 2. 2. 1.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 2.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male 
S u bje cts  
1 4. 3. 2. 2. 2. 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male 
S u bje cts  
1 4. 3. 2. 2. 2. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri n ar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 1 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y  E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 1 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 1 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 1 4.  
Gi vi n ostat Meta b olite  (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 1 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of U ri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle-D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 7  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 2. 1 6.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt 
Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 1 7.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt 
Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 1 8.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt 
Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 1 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri p ti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 2 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 2 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 2 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 2 3.   
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 2 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 2 5.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pt i ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 2 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr o file F oll o wi n g Si n gle-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 2 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n  of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 2 8.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 2. 2 9.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Male S u bjects  
1 4. 3. 2. 2. 2. 3 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual  Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 3 1.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofil e F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 8  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 2. 3 2.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  
Male S u bjects  
1 4. 3. 2. 2. 2. 3 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y E xcreti o n 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  
Fe male S u bjects  
1 4. 3. 2. 2. 2. 3 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 3 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 3 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 3 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 3 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Desc ri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 3 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 4 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 4 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 4 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0) : I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 4 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 4 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat  ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 4 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 4 6.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt 
Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  3 9  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 2. 4 7.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt  
Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 4 8.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of C u m ulati ve A m o u nt 
Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 4 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 5 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 5 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 5 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d u al Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 5 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u n t Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 5 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 5 5.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 5 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 5 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 2. 5 8.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3) : I n di vi d ual Data a n d Descri pti ve Statistics 
C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 2. 5 9.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati v e A m o u nt Uri nar y E xcreti o n Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Male S u bjects  
1 4. 3. 2. 2. 2. 6 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of C u m ulati ve A m o u nt Uri nar y E xcreti o n Pr ofile F ol l o wi n g M ulti ple-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Fe male S u bjects  
1 4. 3. 2. 2. 3.  
Uri nar y P har ma c o ki netic Para meters  
1 4. 3. 2. 2. 3. 1.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 0  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 3. 2.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 3.  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g Si n gle -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d De scri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 3. 5.   
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g  Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 3. 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statisti cs 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 3. 1 1 .  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 1 2 .  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 1 3 .  
Gi vi n ostat Met a b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
1 4. 3. 2. 2. 3. 1 4 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of U ri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 1 5 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g Si n gle -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 1 6 .  
Perc e nta ge of D ose Rec o vere d i n Uri ne f or Gi vi n ostat a n d Gi vi n ostat 
Meta b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3) F oll o wi n g Si n gle -
D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1)  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 1  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 3. 1 7 .  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 3. 1 8 .  
Gi vi n ostat: I n di vi d ual Data a n d  Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 1 9 .  
Gi vi n ostat: I n di vi d ual Data a n d Descri pti ve Statistics of Uri nar y 
P har ma c o ki netic Para meters F oll o wi n g M ulti ple -D ose A d mi nistrati o n of 
Gi vi n ostat ( Da y 1 3)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 2 0 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 3. 2 1 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 2 2 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 4):  I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 2 3 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 3. 2 4 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 2 5 .  
Gi vi n ostat Meta b olite (I T F 2 3 7 5):  I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 2 6 .  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
o f Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple-D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 3. 2 7 .  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 2 8 .  
Gi vi n ostat Meta b olite (I T F 2 4 4 0):  I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Fe male S u bjects  
1 4. 3. 2. 2. 3. 2 9 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  
1 4. 3. 2. 2. 3. 3 0 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Male S u bjects  
1 4. 3. 2. 2. 3. 3 1 .  
Gi vi n ostat Meta b olite (I T F 2 5 6 3):  I n di vi d ual Data a n d Descri pti ve Statistics 
of Uri nar y P har mac o ki netic Para meters F oll o wi n g M ulti ple -D ose 
A d mi nistrati o n of Gi vi n ostat ( Da y 1 3)  –  Fe male S u bjects  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 2  of 1 4 3  
E n d -of -Te xt 
T a bles  
Title  
1 4. 3. 2. 2. 3. 3 2 . 
P erc e nt a g e of D os e R ec ov er e d i n Uri n e f or Givi n ost at a n d Givi n ost at 
M et a b olit es (I TF 2 3 7 4, I T F 2 3 7 5, I TF 2 4 4 0 a n d I T F 2 5 6 3) F oll o wi n g M ulti pl e -
D os e A d mi nistr ati o n of Givi n ost at ( D ay 1 3)  
1 4. 3. 3. S A F E T Y D A T A –  P A R T 3  
1 4. 3. 3. 1.  
A d verse E ve nts  
1 4. 3. 3. 1. 1.  
Pre -Tre at me nt A d verse E ve nts  
1 4. 3. 3. 1. 2.  
Tr e at me nt -E mer ge nt A d verse E ve nts (I)  
1 4. 3. 3. 1. 3.  
Tr e at me nt -E mer ge nt A d verse E ve nts (II)  
1 4. 3. 3. 2.  
Vit al Si g ns  
1 4. 3. 3. 2. 1.  
Descri pti ve Statistics of Vital Si g ns Para meters  
1 4. 3. 3. 2. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of Vital Si g ns Para meters  
1 4. 3. 3. 2. 3.  
S hifts i n Vital Si g ns Para meters  
1 4. 3. 3. 3.  
1 2 -Le a d E C G
1 4. 3. 3. 3. 1.  
Descri pti ve Statistics of 1 2 -Le a d E C G Para meters  
1 4. 3. 3. 3. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of 1 2 -Lea d E C G Para meters  
1 4. 3. 3. 3. 3.  
S hifts i n 1 2 -Le a d E C G Para meters  
1 4. 3. 3. 4.  
He m at ol o g y  
1 4. 3. 3. 4. 1.  
Descri pti ve Statistics of He mat ol o g y Para meters  
1 4. 3. 3. 4. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of He mat ol o g y Para meters  
1 4. 3. 3. 4. 3.  
S hifts i n He mat ol o g y Para meters  
1 4. 3. 3. 5.  
Bi oc h e mistr y  
1 4. 3. 3. 5. 1.  
Descri pti ve Statistics of Bi oc he mistr y Para meters  
1 4. 3. 3. 5. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of Bi oc he mistr y Para meters  
1 4. 3. 3. 5. 3.  
S hifts i n Bi oc he mistr y Para meters  
1 4. 3. 3. 6.  
C o a g ul ati o n  
1 4. 3. 3. 6. 1.  
Descri pti ve Statistics of C oa g ulati o n Para meters  
1 4. 3. 3. 6. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of C oa g ulati o n Para meters  
1 4. 3. 3. 6. 3.  
S hifts i n C oa g ulati o n Para meters  
1 4. 3. 3. 7.  
Uri n al ysis  
1 4. 3. 3. 7. 1.  
Descri pti ve Statistics of Uri nal ysis Para meters  
1 4. 3. 3. 7. 2.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of Uri nal ysis Para meters  
1 4. 3. 3. 7. 3.  
S hifts i n Uri nal ysis Para meters  
1 4. 3. 3. 8.  
B o d y Wei g ht  
1 4. 3. 3. 8. 1.  
Descri pti ve Statistics of B o d y W ei g ht  
1 4. 3. 3. 8. 2.  
Descri pti ve Statistics of B o d y W ei g ht –  Male S u bjects  
1 4. 3. 3. 8. 3.  
Descri pti ve Statistics of B o d y W ei g ht –  Fe male S u bjects  
1 4. 3. 3. 8. 4.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of B o d y W ei g ht  
1 4. 3. 3. 8. 5.  
Descri pti ve Statistics of C ha n ge fr o m Base li ne of B o d y W ei g ht –  Male 
S u bje cts  
1 4. 3. 3. 8. 6.  
Descri pti ve Statistics of C ha n ge fr o m Baseli ne of B o d y W ei g ht –  Fe male 
S u bje cts  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 3  of 1 4 3  
E n d -of -Te xt 
Fi g u r es  
Title  
1 4. 3. P A R T 3  
1 4. 3. 2. P H A R M A C O KI N E TI C D A T A –  P A R T 3  
1 4. 3. 2. 3.  
Pl as m a C o n ce ntr ati o n  Vers us  Ti me Pr ofiles of All S u bje cts  
1 4. 3. 2. 3. 1.  
Gi vi n ostat: Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles of All S u bje cts 
F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) –  Li near Sc ale  
1 4. 3. 2. 3. 2.  
Gi vi n ostat: Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles of All S u bje cts 
F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1 3) –  Li n ear 
S c ale  
1 4. 3. 2. 3. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 1) 
– Li near S cale
1 4. 3. 2. 3. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Plas ma C o nc e ntrati o n  Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 
1 3) –  Li near Sc ale
1 4. 3. 2. 3. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g Si n gle -D ose A d mi nistrati o n  of Gi vi n ostat ( Da y 1) 
– Li near S cale
1 4. 3. 2. 3. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 
1 3) –  Li near Sc ale
1 4. 3. 2. 3. 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi v i n ostat ( Da y 1) 
– Li near S cale
1 4. 3. 2. 3. 8.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 
1 3) –  Li near Sc ale
1 4. 3. 2. 3. 9.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g Si n gle -D ose A d mi nistrati o n of Gi v i n ostat ( Da y 1) 
– Li near S cale
1 4. 3. 2. 3. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofiles 
of All S u bje cts F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 
1 3) –  Li near Sc ale
1 4. 3. 2. 4.  
I n di vi d u al Pl as m a C o nc e ntr ati on  Vers us  Ti me Pr ofiles  
1 4. 3. 2. 4. 1.  
Gi vi n ostat: I n di vi d ual Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g 
Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 4. 2.  
Gi vi n ostat: I n di vi d ual Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g 
Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi ni strati o n of 
Gi vi n ostat –  S e mi -L o garit h mic S cale  
1 4. 3. 2. 4. 3.  
Gi vi n ostat: I n di vi d ual Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g 
M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o Da y 1 3) –  Li near Sc ale  
1 4. 3. 2. 4. 4.  
Gi vi n ostat: I n di vi d ual Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile F oll o wi n g 
M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o Da y 1 3) –  S e mi -
L o garit h mic Sc ale  
1 4. 3. 2. 4. 5.  
Gi vi n ostat: I n di vi d ual Tr o u g h Plas ma C o nc e ntrati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o Da y 1 3) –  
Li near S cale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 4  of 1 4 3  
E n d -of -Te xt 
Fi g u r es  
Title  
1 4. 3. 2. 4. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n os tat –  Li near Sc ale  
1 4. 3. 2. 4. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic S c ale  
1 4. 3. 2. 4. 8.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 9.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  S e mi -L o garit h mic S cale  
1 4. 3. 2. 4. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Tr o u g h Plas ma C o nc e ntrati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat 
( Da y 9 t o Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 1 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 4. 1 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic S c ale  
1 4. 3. 2. 4. 1 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5) : I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 1 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti p le-D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  S e mi -L o garit h mic S cale  
1 4. 3. 2. 4. 1 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Tr o u g h Plas ma C o nc e ntrati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat 
( Da y 9 t o Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 1 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 4. 1 7.  
Gi vi n ostat Meta b olite ( I T F 2 4 4 0): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic S c ale  
1 4. 3. 2. 4. 1 8.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 1 9.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  S e mi -L o garit h mic S cale  
1 4. 3. 2. 4. 2 0.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Tr o u g h Plas ma C o nc e ntrati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat 
( Da y 9 t o Da y 1 3) –  Li near S cale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 5  of 1 4 3  
E n d -of -Te xt 
Fi g u r es  
Title  
1 4. 3. 2. 4. 2 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ult i ple-D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 4. 2 2.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  S e mi -L o garit h mic S c ale  
1 4. 3. 2. 4. 2 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  Li near S cale  
1 4. 3. 2. 4. 2 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma C o n c e ntrati o n Vers us  
Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat ( Da y 9 t o 
Da y 1 3) –  S e mi -L o garit h mic S cale  
1 4. 3. 2. 4. 2 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Tr o u g h Plas ma C o nc e ntrati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistrati o n of Gi vi n ostat 
( Da y 9 t o Da y 1 3) –  Li near S cale  
1 4. 3. 2. 5.  
I n di vi d u al Uri n ar y E xc reti o n Vers us  Ti me Pr ofiles  
1 4. 3. 2. 5. 1.  
Gi vi n ostat: I n di vi d ual Uri nar y E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g 
Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) A d mi nistrati o n of 
Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 2.  
Gi vi n ostat: I n di vi d ual C u m ulati ve A m o u nt Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual C u m ulati ve A m o u nt Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual C u m ulati ve A m o u nt Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 8.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual C u m ulati ve A m o u nt Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 9.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d u al Uri nar y E xcreti o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -D ose ( Da y 1 3) 
A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
1 4. 3. 2. 5. 1 0.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual C u m ulati ve A m o u nt Uri nar y 
E xcreti o n Vers us  Ti me Pr ofile  F oll o wi n g Si n gle -D ose ( Da y 1) a n d M ulti ple -
D ose ( Da y 1 3) A d mi nistrati o n of Gi vi n ostat –  Li near Sc ale  
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V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 6  of 1 4 3  
List of S u bject D at a Listi n gs ( S e cti o n 1 6. 2 of C S R)  
T he f oll o wi n g Data Listi n gs will be pr o d uc e d f or Se cti o n 1 6. 2. S u bje ct Data Listi n gs of t he C S R.  
If ne c essar y, a d diti o nal Data Listi n gs s h o ul d be pre pare d. 
Listi n g N o.   
Title  
1 6. 2. S U BJ E C T S D A T A LI S TI N G  
1 6. 2. 3 . P art 3  
1 6. 2. 3. 1.   
S u bject Dis p ositi o n  
1 6. 2. 3. 1. 1.  
S u bje ct Dis p ositi o n  
1 6. 2. 3. 2.   
Pr ot oc ol De vi ati o ns  
1 6. 2. 3. 2. 1.  
Bl o o d S a m pli n g Ti mes De viati o ns  
1 6. 2. 3. 2. 2.  
Ot her Pr ot oc ol De viati o ns  
1 6. 2. 3. 3.   
E xcl u d e d D at a fr o m t h e P h ar m ac o ki n etic A n al ysis  
1 6. 2. 3. 3. 1.  
Plas ma C o nc e ntrati o ns  
1 6. 2. 3. 3. 1. 1.  
I n di vi d ual Data of Plas ma C o nc e ntrati o ns 
1 6. 2. 3. 3. 2.  
Plas ma C o nc e ntrati o n Vers us Ti me Pr ofiles  
1 6. 2. 3. 3. 2. 1.  
I n di vi d ual Plas ma C o nc e ntrati o n Vers us Ti me Pr ofiles –  Li near S cale  
1 6. 2. 3. 3. 2. 2.  
I n di vi d ual Plas ma C o nc e ntrati o n Vers us Ti me Pr ofiles –  S e mi -L o garit h mic 
S c ale  
1 6. 2. 3. 3. 3.  
Uri ne E xcreti o n  
1 6. 2. 3. 3. 3. 1.  
I n di vi d ual Data of Plas ma C o nc e ntrati o ns 
1 6. 2. 3. 3. 4.  
Uri ne E xcreti o n Vers us Ti me Pr ofiles  
1 6. 2. 3. 3. 4. 1.  
Uri ne E xcreti o n Vers us Ti me Pr ofiles –  Li near S cale  
1 6. 2. 3. 4.   
De m o gr a p hic a n d Ot h e r B aseli n e D at a  
1 6. 2. 3. 4. 1.  
De m o gra p hic Data  
1 6. 2. 3. 4. 2.  
Fertilit y/ C o ntra c e pti o n  
1 6. 2. 3. 4. 2. 1.  
Fe male Fertilit y/ C o ntra c e pti o n  
1 6. 2. 3. 4. 2. 2.  
Male Fertilit y/ C o ntra c e pti o n  
1 6. 2. 3. 4. 3.  
Dr u gs of A b use, Et ha n ol a n d C oti ni ne  
1 6. 2. 3. 4. 4.  
Viral Ser ol o g y at Scre e ni n g  
1 6. 2. 3. 4. 5.  
Pre vi o us a n d C o nc o mita nt Me dic ati o n  
1 6. 2. 3. 4. 6.  
S A R S -C O V -2 Test  
1 6. 2. 3. 5.   
C o m pli a nc e  
1 6. 2. 3. 5. 1.  
I n vesti gati o nal Pr o d uct A d mi nistrati o n 
1 6. 2. 3. 6.   
I n di vi d u al P h ar m ac o ki netic D at a 
1 6. 2. 3. 6. 1.  
Gi vi n ostat: I n di vi d ual P har ma c o ki netic Data  
1 6. 2. 3. 6. 1. 1.  
Gi vi n ostat: I n di vi d ual Dr u g Plas ma C o nc e ntrati o n Data  
1 6. 2. 3. 6. 1. 2.  
Gi vi n ostat: I n di vi d ual Plas ma P har ma c o ki netic Para meters  
1 6. 2. 3. 6. 1. 3.  
Gi vi n ostat: I n di vi d ual Plas ma P har ma c o ki netic Pr ofiles  
1 6. 2. 3. 6. 1. 4.  
Gi vi n ostat: I n di vi d ual Uri ne E xcreti o n Data 
1 6. 2. 3. 6. 1. 5.  
Gi vi n ostat: I n di vi d ual Uri ne P har ma c o ki netic Para meters  
1 6. 2. 3. 6. 1. 6.  
Gi vi n ostat: I n di vi d ual Uri ne P har ma c o ki netic Pr ofiles  
1 6. 2. 3. 6. 1. 7.  
Gi vi n ostat: D oc u me ntati o n of Statistic al A nal ysis  
1 6. 2. 3. 6. 1. 7. 1.   
Gi vi n ostat: Plas ma N o n -C o m part me ntal A nal ysis O ut p ut  
1 6. 2. 3. 6. 1. 7. 2.  
Gi vi n ostat: Plas ma N o n -C o m part me ntal A nal ysis Pl ots  
1 6. 2. 3. 6. 1. 7. 3.  
Gi vi n ostat: Uri ne N o n -C o m part me ntal A nal ysis O ut p ut  
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V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 7  of 1 4 3  
Listi n g N o.   
Title  
1 6. 2. 3. 6. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual P har ma c o ki netic Data 
1 6. 2. 3. 6. 2. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Dr u g Plas ma C o nc e ntrati o n 
Data  
1 6. 2. 3. 6. 2. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Plas ma P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 2. 3.  
Gi vi n ostat Meta b olite ( I T F 2 3 7 4): I n di vi d ual Plas ma P har ma c o ki netic 
Pr ofiles  
1 6. 2. 3. 6. 2. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Uri ne E xcreti o n Data  
1 6. 2. 3. 6. 2. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): I n di vi d ual Uri ne P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 2. 6.  
Gi vi n ostat Me ta b olite (I T F 2 3 7 4): I n di vi d ual Uri ne P har ma c o ki netic Pr ofiles 
1 6. 2. 3. 6. 2. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): D oc u me ntati o n of Statistic al A nal ysis  
1 6. 2. 3. 6. 2. 7. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Plas ma N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 2. 7. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Plas ma N o n -C o m part me ntal A nal ysis Pl ots  
1 6. 2. 3. 6. 2. 7. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 4): Uri ne N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual P har ma c o ki netic D ata 
1 6. 2. 3. 6. 3. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Dr u g Plas ma C o nc e ntrati o n 
Data  
1 6. 2. 3. 6. 3. 2.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Plas ma P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 3. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Plas ma P har ma c o ki netic 
Pr ofiles  
1 6. 2. 3. 6. 3. 4.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Uri ne E xcreti o n Data  
1 6. 2. 3. 6. 3. 5.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Uri ne P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 3. 6.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): I n di vi d ual Uri ne P har ma c o ki netic Pr ofiles 
1 6. 2. 3. 6. 3. 7.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): D oc u me ntati o n of Statistic al A nal ysis  
1 6. 2. 3. 6. 3. 7. 1.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Plas ma N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 3. 7. 2.  
Gi vi n o stat Meta b olite (I T F 2 3 7 5): Plas ma N o n-C o m part me ntal A nal ysis Pl ots  
1 6. 2. 3. 6. 3. 7. 3.  
Gi vi n ostat Meta b olite (I T F 2 3 7 5): Uri ne N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 4.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual P har ma c o ki netic Data  
1 6. 2. 3. 6. 4. 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Dr u g Plas ma C o nc e ntrati o n 
Data  
1 6. 2. 3. 6. 4. 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Plas ma P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 4. 3.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Plas ma P har ma c o ki netic 
Pr ofiles  
1 6. 2. 3. 6. 4. 4.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Uri ne E xcreti o n Data  
1 6. 2. 3. 6. 4. 5.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d ual Uri ne P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 4. 6.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): I n di vi d u al Uri ne P har ma c o ki netic Pr ofiles  
1 6. 2. 3. 6. 4. 7.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): D oc u me ntati o n of Statistic al A nal ysis  
1 6. 2. 3. 6. 4. 7. 1.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Plas ma N o n -C o m part me ntal A nal ysis 
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V er si o n: 1. 0  
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St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 8  of 1 4 3  
Listi n g N o.   
Title  
O ut p ut  
1 6. 2. 3. 6. 4. 7. 2.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Plas ma N o n -C o m part me ntal A nal ysis Pl ots  
1 6. 2. 3. 6. 4. 7. 3.  
Gi vi n ostat Meta b olite (I T F 2 4 4 0): Uri ne N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual P har ma c o ki netic Data  
1 6. 2. 3. 6. 5. 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Dr u g Plas ma C o nc e ntrati o n 
Data  
1 6. 2. 3. 6. 5. 2.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma P har ma c o ki netic 
Par a meters 
1 6. 2. 3. 6. 5. 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Plas ma P har ma c o ki netic 
Pr ofiles  
1 6. 2. 3. 6. 5. 4.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Uri ne E xcreti o n Data  
1 6. 2. 3. 6. 5. 5.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Uri ne P har ma c o ki netic 
Para meters  
1 6. 2. 3. 6. 5. 6.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): I n di vi d ual Uri ne P har ma c o ki netic Pr ofiles  
1 6. 2. 3. 6. 5. 7.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): D oc u me ntati o n of Statistic al A nal ysis  
1 6. 2. 3. 6. 5. 7. 1.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Plas ma N o n-C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 6. 5. 7. 2.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Plas ma N o n -C o m part me ntal A nal ysis Pl ots  
1 6. 2. 3. 6. 5. 7. 3.  
Gi vi n ostat Meta b olite (I T F 2 5 6 3): Uri ne N o n -C o m part me ntal A nal ysis 
O ut p ut  
1 6. 2. 3. 7.  
A d verse E ve nt Listi n gs ( E ac h S u bject)  
1 6. 2. 3. 7. 1.  
Pre -Tre at me nt A d verse E ve nts  
1 6. 2. 3. 7. 2.  
Tr e at me nt -E mer ge nt A d verse E ve nts  
1 6. 2. 3. 7. 3.  
S eri o us A d verse E ve nts (I)  
1 6. 2. 3. 8.   
Listi n gs of L a b or at or y Me as u re me nts b y S u bject  
1 6. 2. 3. 8. 1.  
N or mal Ra n ge of La b orat or y Val ues  
1 6. 2. 3. 8. 2.  
He mat ol o g y (I)  
1 6. 2. 3. 8. 3.  
He mat ol o g y (II)  
1 6. 2. 3. 8. 4.  
Bi oc he mistr y (I)  
1 6. 2. 3. 8. 5.  
Bi oc he mistr y (II)  
1 6. 2. 3. 8. 6.  
Bi oc he mistr y (III)  
1 6. 2. 3. 8. 7.  
Bi oc he mistr y (I V)  
1 6. 2. 3. 8. 8.  
Bi oc he mistr y ( V)  
1 6. 2. 3. 8. 9.  
C oa g ulati o n  
1 6. 2. 3. 8. 1 0.  
Uri nal ysis  
1 6. 2. 3. 8. 1 1.  
Uri ne Micr osc o p y  
1 6. 2. 3. 8. 1 2.  
Pre g na nc y Test  
1 6. 2. 3. 8. 1 3.  
A d diti o nal ( N ot Pla n ne d) La b orat or y S afet y Tests  
1 6. 2. 3. 9.   
Vit al Si g ns  
1 6. 2. 3. 1 0.   
1 2 -Le a d E C G
1 6. 2. 3. 1 1.   
Uri n e S a m pli n g  
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V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  4 9  of 1 4 3  
1 2. 
R E F E R E N C E S
[ 1] I T F/ 2 3 5 7/ 5 5 Cli nic al St u d y Pr ot oc ol, Versi o n 1. 0 , 2 9 N O V 2 0 2 1
[ 2] F o o d a n d Dr u g A d mi nistrati o n ( F D A), Cli nic al Dr u g I nteracti o n St u dies - C yt oc hr o me P 4 5 0
E nz y me - a n d Tra ns p orter-Me diate d Dr u g I ntera cti o ns G ui da nc e f or I n d ustr y ( 2 0 2 0).
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 0  of 1 4 3  
1 3. 
A P P E N DI C E S
A P P E N DI X A.  Pl a n n e d T a bles, Fi g u res, a n d S u bje ct D at a Listi n gs  
A. 1. 
I n-te xt T a bles a n d Fi g u res –  F or C S R S y n o psis  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 1  of 1 4 3  
A. 1. 1. 
P art 3  
S Y N O P SI S T A B L E S (1 ) 
Gi vi n ost at a n d Its M ai n M et a b olites (I T F 2 3 7 4  a n d I T F 2 3 7 5,): S u m m ar y St atistics  of t h e Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
C ma x  (< u nits C > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
T ma x  ( h) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x)
A U C 0 -t (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
% A U C
e xtra p ( %) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
λ z ( 1/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
x. x x x ( x x. x %)
t½  ( h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis 
T m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3  
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 2  of 1 4 3  
S Y N O P SI S T A B L E S ( 2 ) 
Gi vi n ost at M et a b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  of t he Pl as m a P h ar m ac o ki n etic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  
P ar a meter ( u nit)  
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
C ma x  (< u nits C > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
T ma x  ( h) 
x x. x x ( x x. x x –  x x. x x)
x x. x x ( x x. x x –  x x. x x)
A U C 0 -t (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
% A U C
e xtra p ( %) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
λ z ( 1/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
t½  ( h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis 
T m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his ta ble will prese nt t he s u m mar y statistics of t he p har mac o ki netic para meters calc ulate d f or Part 3 
P har ma c o ki netic A nal ysis P o p ulati o n. I n c ase a p har ma c o ki netic para meter c o ul d n ot be calc ulate d f or o ne or 
m ore s u bje cts i n t he Part 1 P har ma c o ki n etic A nal ysis P o p ulati o n, t he p har mac o ki netic para meter s h o ul d be 
f oll o we d b y t he # s y m b ol a n d ac c o m pa nie d b y a f o ot n ote: ‘ # F or < Para meter(s) > , n =x x , f or <I n vesti gati o nal 
Pr o d uct >  pr o d uct <, a n d n = x x, f or <I n vesti gati o nal Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 3  of 1 4 3  
S Y N O P SI S T A B L E S ( 3 ) 
Gi vi n ost at a n d Its M ai n M et a b olites (I T F 2 3 7 4  a n d I T F 2 3 7 5,): S u m m ar y St atistics  of t h e Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  
P ar a mete r ( u nit) 
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
C ma x,ss  (< u nits C > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
T ma x,ss  ( h) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x)
A U C 0 -τ,ss (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 -t (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
λ z ( 1/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
x. x x x ( x x. x %)
t½  ( h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
C L ss/ F ( L/ h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
V D / F ( L) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis 
T m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki netic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 4  of 1 4 3  
S Y N O P SI S T A B L E S ( 4 ) 
Gi vi n ost at M et a b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  of t he Pl as m a P h ar m ac o ki n etic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  
P ar a meter ( u nit)  
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
C ma x,ss  (< u nits C > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
T ma x,ss  ( h) 
x x. x x ( x x. x x –  x x. x x)
x x. x x ( x x. x x –  x x. x x)
A U C 0 -τ,ss (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 -t (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
λ z ( 1/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
t½  ( h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
C L ss/ F ( L/ h) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
V D / F ( L) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis  
T m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 5  of 1 4 3  
S Y N O P SI S T A B L E S ( 5 ) 
Gi vi n ost at a n d Its M ai n M et a b olites (I T F 2 3 7 4  a n d  I T F 2 3 7 5): S u m m ar y S t atistics of t h e Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)
 1 0 
S Y N O P SI S T A B L E S ( 6 ) 
Gi vi n ost at M et a b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  of t he Uri n ar y P h ar m ac o ki netic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)
 1 1 
S Y N O P SI S T A B L E S ( 7 ) 
Gi vi n ost at a n d Its M ai n M et a b olites (I T F 2 3 7 4  a n d  I T F 2 3 7 5): S u m m ar y St atistics  of t h e Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3 )  1 0  
S Y N O P SI S T A B L E S ( 8 ) 
Gi vi n ost at M et a b olites (I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  of t he Uri n ar y P h ar m ac o ki netic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)
 1 1  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 6  of 1 4 3  
1 0 T o be ge ner ate d as f oll o ws:  
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
R ma x,ss  (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
t uma x  ( h) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x) 
x x. x x ( x x. x x –  x x. x x)
A mt C U M  (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U R C 0 -t (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
R E C % ( %)  
x x. x x ( x x. x %)
x x. x x ( x x. x %)
x x. x x ( x x. x %)
C L R / F ( L/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
x. x x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis  
tu m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
1 1 T o be ge ner ate d as f oll o ws:  
P ar a meter ( u nit)  
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
R ma x,ss  (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
t uma x  ( h) 
x x. x x ( x x. x x –  x x. x x)
x x. x x ( x x. x x –  x x. x x)
A mt C U M  (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
A U R C 0 -t (< u nits > ) 
x x. x x ( x x. x %)
x x. x x ( x x. x %)
R E C % ( %)  
x x. x x ( x x. x %)
x x. x x ( x x. x %)
C L R / F ( L/ h) 
x. x x x ( x x. x %)
x. x x x ( x x. x %)
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis 
tu m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 7  of 1 4 3  
S Y N O P SI S FI G U R E S  (9 ) 
Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -
D ose ( D a y 1) a n d M ulti ple-D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at. A –  Li n e ar S c ale; B –  Se mi -
L o g arit h mic S c ale  
S Y N O P SI S FI G U R E S  (1 0 ) 
Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr a ti o n of Gi vi n ost at ( D a y 
1). A –  Li n e ar S c ale; B –  Se mi -L o g arit h mic Sc ale  
S Y N O P SI S FI G U R E S  (1 1 ) 
Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at ( D a y 
1). A –  Li n e ar S c ale; B –  Se mi -L o g arit h mic Sc ale  
S Y N O P SI S FI G U R E S  (1 2 ) 
Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at ( D a y 
1). A –  Li n e ar S c ale; B –  Se mi -L o g arit h mic Sc ale  
S Y N O P SI S FI G U R E S  (1 3 ) 
Gi vi n ost at M et a b olite (I T F 2 5 6 3): G e o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at ( D a y 
1). A –  Li n e ar S c ale; B –  Se mi -L o g arit h mic Sc ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 8  of 1 4 3  
A. 2.   
I n-te xt T a bles a n d Fi g u res –  F or C S R B o d y Te xt  
A. 2. 1.   
P a rt 3 
T a ble 1. A.  St u d y Fl o w -C h art –  P art 3  
N ote: T o be c a pt ure d fr o m t he Cli nic al St u dy Pr ot oc ol ( C S P) a n d A me n d me nts.  
T a ble 1. B.  I d e ntit y of I n vesti g ati o n al Pr o d ucts –  P art 3  
N ote: T o be ge ner ate d by t he Me dic al Writi n g ( M W).  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  5 9  of 1 4 3  
T a ble 1. C.  S u m m ar y of S u bje cts Dis p ositi o n –  P art 3  
Dis p ositi o n  
N u m b er of 
S u bjects  
A d mitte d t o Tre at me nt Peri o d  
x x  
Disc o nti n ue d after First D osi n g  
x x  
    Re as o n  
- < Re as o n >
x x  
P art 3  S afet y A n al ysis P o p ul ati o n  
x x  
P art 3  P h ar m ac o ki n etic A n al ysis P o p ul ati o n  
x x  
C o m plete d P art 3  of St u d y  
x x  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 0  of 1 4 3  
T a ble 1. D.  S u m m ar y of De m o gr a p hic D at a of t he P h ar m ac o ki n etic A n al ysis P o p ul ati o n s 
De m o gr a p h y  
P ar a meter  
Si n gle -D ose  
M ulti ple -D ose  
A ge ( ye ars)  
n  
x x  
x x  
Mea n  
x x  
x x  
S D  
x x. x
x x. x
Me dia n  
x x
x x
Mi ni m u m  
x x
x x
Ma xi m u m  
x x
x x
S e x, n ( %)  
n  
x x  
x x  
Male  
x x ( x x. x %)  
x x ( x x. x %)  
Fe male  
x x ( x x. x %)  
x x ( x x. x %)  
Ra c e, n ( %)  
n  
x x  
x x  
< Ra c e >  
x x ( x x. x %)  
x x ( x x. x %)  
W ei g ht ( k g)  
n  
x x  
x x  
Mea n  
x x. x
x x. x
S D  
x x. x x
x x. x x
Me dia n  
x x. x
x x. x
Mi ni m u m  
x x. x
x x. x
Ma xi m u m  
x x. x
x x. x
Hei g ht (c m)  
n  
x x  
x x  
Mea n  
x x x  
x x x  
S D  
x x. x
x x. x
Me dia n  
x x x
x x x
Mi ni m u m  
x x x
x x x
Ma xi m u m  
x x x
x x x
B o d y Mass I n de x ( k g/ m 2) n  
x x  
x x  
Mea n  
x x. x
x x. x
S D  
x x. x x
x x. x x
Me dia n  
x x. x
x x. x
Mi ni m u m  
x x. x
x x. x
Ma xi m u m  
x x. x
x x. x
n –  N u m ber of S u bjects; S D –  Sta n dar d De viati o n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 1  of 1 4 3  
T a ble 1. E.  Gi vi n ost at a n d M et a b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  
of t he Pl as m a P h ar m ac o ki n etic P ar a mete rs F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 
1)  
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
C ma x  (< u nits C > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
T ma x  ( h) 
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
A U C 0 -t (< u nits A > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
% A U C
e xtra p ( %)  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
λ z ( 1/ h) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
t½  ( h) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis a n d 9 5 % c o nfi de nce i nter val 
of t he G m e a n  wit hi n s q uare brac kets  
T m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 2  of 1 4 3  
T a ble 1. F.  Gi vi n ost at a n d M et a b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  
of t he Pl as m a P h ar m ac o ki n etic P ar a mete rs F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) 
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
C ma x,ss  (< u nits C > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
T ma x,ss  ( h) 
x x. x x
( x x. x x –  x x. x x)  
x x. x x
( x x. x x –  x x. x x)  
x x. x x
( x x. x x –  x x. x x)  
x x. x x
( x x. x x –  x x. x x)  
x x. x x
( x x. x x –  x x. x x)  
A U C 0 -τ,ss (< u nits A > ) x x. x x ( x x. x %)  
[ x x. x x –  x x. x x]  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
A U C 0 -t (< u nits A > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
A U C 0 - (< u nits A > ) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
λ z ( 1/ h) 
x. x x x ( x x. x %)
[ x. x x x –  x. x x x]
x. x x x ( x x. x %)
[ x. x x x –  x. x x x]
x. x x x ( x x. x %)
[ x. x x x –  x. x x x]
x. x x x ( x x. x %)
[ x. x x x –  x. x x x]
x. x x x ( x x. x %)
[ x. x x x –  x. x x x]
t½  ( h) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
C L ss/ F ( L/ h)  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
V D / F ( L) 
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis a n d 9 5 % c o nfi de nce i nter val 
of t he G m e a n  wit hi n s q uare brac kets  
T m a x ,ss val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki netic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 3  of 1 4 3  
T a ble 1. G.  Gi vi n ost at a n d M et a b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  
of t he  Pl as m a P h ar m ac o ki n etic P ar a mete rs Ac c u m ul ati o n  I n d e x 
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
I T F 2 4 4 0 
( n = x x ) 
I T F 2 5 6 3 
( n = x x ) 
C ma x  
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x
A U C 0 -t 
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x 
x x. x x ± x x. x x
n  –  N u m ber  of  S u bjects  
Val ues are arit h metic mea n ( A m e a n ) ± sta n dar d de viati o n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 4  of 1 4 3  
T a ble 1. H.  Gi vi n ost at a n d M et a b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  
of t he Uri n ar y P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 
1) 2 1
T a ble 1.I.  Gi vi n ost at a n d M et a b olites (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0 a n d I T F 2 5 6 3): S u m m ar y St atistics  
of t he Uri n ar y P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) 2 1  
1 T o be ge ner ate d as f oll o ws:  
P ar a meter ( u nit)  
Gi vi n ost at  
( n = x x ) 
I T F 2 3 7 4 
( n = x x ) 
I T F 2 3 7 5 
( n = x x ) 
I T F 2 4 4 0 
( n = x x ) 
I T F 2 56 3  
( n = x x ) 
R ma x,ss  (< u nits > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
t uma x  ( h) 
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
x x. x x ( x x. x x –
x x. x x)
A mt C U M  (< u nits > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
A U R C 0 -t (< u nits > )  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
R E C % ( %)   
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
C L R / F ( L/ h)  
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
x x. x x ( x x. x %)
[ x x. x x –  x x. x x]
n  –  N u m ber  of  S u bjects  
Val ues are ge o metric mea n ( G m e a n ) wit h ge o metric c oefficie nt of variati o n ( G C V %) wit hi n pare nt hesis a n d 9 5 % c o nfi de nce i nter val 
of t he G m e a n  wit hi n s q uare brac kets  
tu m a x  val ues  are me dia n  wit h  ra n ge bet wee n  pare nt heses  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T his t a ble will prese nt t he s u m m ary st atistics of t he p h ar m ac oki netic p ar a meters c alc ul ate d f or P art 3 
P h ar m ac oki netic A n alysis P o p ul ati o n. I n c ase a p h ar m ac oki netic p ar a meter c o ul d n ot be c alc ul ate d f or o ne 
or m ore s u bje cts i n t he P art 1 P h ar m ac oki n etic A n alysis P o p ul ati o n, t he p h ar m ac oki netic p ar a meter s h o ul d 
be f oll o we d by t he # sy m b ol a n d acc o m p a nie d by a f o ot n ote: ‘ # F or < P ar a meter(s) > , n =x x , f or 
<I nvesti g ati o n al Pr o d uct >  pr o d uct <, a n d n =xx, f or <I nv esti g ati o n al Pr o d uct > pr o d uct > ’. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 5  of 1 4 3  
T a ble 1. J.  S u m m ar y of Tr e at me nt -E me r ge nt A d verse E ve nts ( T E A Es)  
T ot al  
( N = x x ) 
All T E A Es  
Dr u g -rel ate d T E A Es  
N u m b er of S u bjects { Nr. of 
T E A Es} ( % of S u bje cts)  
x x { x x} ( x x %)  
x x { x x} ( x x %)  
M e d D R A  
S yste m  Or g a n  Cl ass  ( S O C) 
   Preferre d  Ter m  ( P T) 
< T E A Es S O C >  
x x { x x} ( x x %)  
x x { x x} ( x x %)  
   < T E A Es S O C >  
x x { x x } ( x x %)  
x x { x x } ( x x %)  
<I nsert as ma n y r o ws as dee me d 
ne c essar y >  
S e verit y  
   Mil d  
x x { x x} ( x x %)  
x x { x x} ( x x %)  
   M o d er ate  
x x { x x} ( x x %)  
x x { x x} ( x x %)  
   S e ver e  
x x { x x} ( x x %)  
x x { x x} ( x x %)  
Me d D R A –  Me dical Dicti o nar y f or Re g ulat or y Acti vities  
Dr u g -relate d T E A Es  are t h ose w hic h ca usalit y was assesse d as “ Reas o na bl y P ossi ble” b y t he I n vesti gat or.  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 6  of 1 4 3  
   
  
  
  
 
Fi g u r e 1. A. 1.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple-D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
Fi g u r e 1. A. 2.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at  –  Se mi -
L o g arit h mic S c ale  
Fi g u r e 1. A. 3.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti m e Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
Fi g u r e 1. A. 4.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  S e mi -L o g a rit h mic S c ale 
Fi g u r e 1. A. 5.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) Tr o u g h Pl as m a C o n ce ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
  
  
 
Fi g u r e 1. B. 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. B. 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI)  Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  S e mi -L o g arit h mic S c ale  
Fi g u r e 1. B. 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar 
S c ale  
Fi g u r e 1. B. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Se mi -
L o g arit h mic S c ale  
Fi g u r e 1. B. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) Tr o u g h Pl as m a 
C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o 
D a y 1 3) –  Li n e ar S c ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 7  of 1 4 3  
  
  
 
Fi g u r e 1. C. 1.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. C. 2.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o n c e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  S e mi -L o g arit h mic S c ale  
Fi g u r e 1. C. 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar 
S c ale  
Fi g u r e 1. C. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Se mi -
L o g arit h mic S c ale  
Fi g u r e 1. C. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) Tr o u g h Pl as m a 
C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o 
D a y 1 3) –  Li n e ar S c ale  
  
  
 
Fi g u r e 1. D. 1.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. D. 2.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me  Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  S e mi -L o g arit h mic S c ale  
Fi g u r e 1. D. 3.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar 
S c ale  
Fi g u r e 1. D. 4.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Se mi -
L o g arit h mic S c ale  
Fi g u r e 1. D. 5.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) Tr o u g h Pl as m a 
C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o 
D a y 1 3) –  Li n e ar S c ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 8  of 1 4 3  
  
  
 
Fi g u r e 1. E. 1.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. E. 2.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me  Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at –  S e mi -L o g arit h mic S c ale  
Fi g u r e 1. E. 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar 
S c ale  
Fi g u r e 1. E. 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) Pl as m a C o nc e ntr ati o n 
Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Se mi -
L o g arit h mic S c ale  
Fi g u r e 1. E. 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) Tr o u g h Pl as m a 
C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o 
D a y 1 3) –  Li n e ar S c ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  6 9  of 1 4 3  
  
  
 
Fi g u r e 1. F. 1.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) of Uri n ar y E xcr eti o n  Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at  –  Li n e ar Sc ale  
Fi g u r e 1. F. 2.  Gi vi n ost at: Ge o metric Me a n ( 9 5 % CI) of C u m ul ati ve A m o u nt Uri n ar y E xc reti o n  Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1)  a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at  –  
Li n e ar  Sc ale  
  
  
 
Fi g u r e 1. G. 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) of Uri n ar y E xcr eti o n  
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n o f 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. G. 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Ge o metric M e a n ( 9 5 % CI) of C u m ul ati ve A m o u nt 
Uri n ar y E xc reti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) 
A d mi nistr ati o n of Gi vi n ost at –  Li ne ar S c ale  
  
  
 
Fi g u r e 1. H. 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) of Uri n ar y E xcr eti o n  
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at  –  Li n e ar S c ale  
Fi g u r e 1. H. 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Ge o metric M e a n ( 9 5 % CI) of C u m ul ati ve A m o u nt 
Uri n ar y E xc reti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) 
A d mi nistr ati o n of Gi vi n ost at  –  Li ne ar S c ale  
  
  
 
Fi g u r e 1.I. 1.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) of Uri n ar y E xcr eti o n  Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at  –  
Li n e ar Sc ale  
Fi g u r e 1.I. 2.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Ge o metric M e a n ( 9 5 % CI) of C u m ul ati ve A m o u nt 
Uri n ar y E xc reti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) 
A d mi nistr ati o n of Gi vi n ost at  –  Li ne ar S c ale  
  
  
 
Fi g u r e 1. J. 1.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) of Uri n ar y E xcr eti o n  Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at  –  
Li n e ar Sc ale  
Fi g u r e 1. J. 2.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Ge o metric M e a n ( 9 5 % CI) of C u m ul ati ve A m o u nt 
Uri n ar y E xc reti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ult i ple-D ose ( D a y 1 3) 
A d mi nistr ati o n of Gi vi n ost at  –  Li ne ar S c ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 0  of 1 4 3  
A. 3. 
T a bles, Fi g u res a n d Gr a p hs Refer re d t o B ut N ot I ncl u d e d i n t h e Te xt ( S e cti o n 1 4 of C S R)  
1 4. 1. 1.  S A F E T Y D A T A  –  
A. 3. 1.   
P art 3  
1 4. 2.  P A R T  3  
1 4. 2. 1.  D E M O G R A P HI C D A T A  –  P A R T 3  
1 4. 2. 1. 1.  De m o gr a p hic D at a –  P art 3 S afet y A n al ysis P o p ul ati o n 2 
1 4. 2. 1. 2.  De m o gr a p hic D at a –  P art 3 Si n gle -D ose P h ar m ac o ki netic A n al ysis P o p ul ati o n 2 
1 4. 2. 1. 3.  De m o gr a p hic D at a –  P art 3 M ulti ple -D ose P h ar m ac o ki n etic A n al ysis P o p ul ati o n 2 
2 T o be ge ner ate d as f oll o ws:  
S u bject N o.   
S e x  
R ace  
A ge  
( ye ars) 
Hei g ht  
(c m) 
Wei g ht  
( k g) 
B MI  
( k g/ m2) 
< S u bject I D >  
< M ale / 
Fe male >  
< Race >  
x x  
x x x   
x x. x
x x. x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
M ea n  
x x  
x x x   
x x. x
x x. x
S D  
x x. x
x x. x 
x x. x x 
x x. x x
M e dia n  
x x
x x x
x x. x
x x. x
Mi ni m u m  
x x
x x x
x x. x
x x. x
M a xi m u m  
x x
x x x
x x. x
x x. x
B MI  –  B o d y  Mass  I n de x; n –  N u m ber of S u bjects; S D –  Sta n dar d De viati o n 
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 4. 2. 1. 4.  S u bjects Pr e m at ur el y Disc o nti n ue d Afte r First D osi n g  
S u bject N o.  
Ti m e of Disc o nti n u ati o n  
Re as o n f or Disc o nti n u ati o n  
< S u bject I D >  
< Da y # >  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 1  of 1 4 3  
1 4. 2. 2.  P H A R M A C O KI N E TI C D A T A  –  P A R T 3  
1 4. 2. 2. 1.  Pl as m a P h ar m ac o ki n etic D at a  
1 4. 2. 2. 1. 1.  De vi ati o ns fr o m Bl o o d S a m pli n g Sc he d ule  
1 4. 2. 2. 1. 1. 1.  De vi ati o ns fr o m Bl o o d S a m pli n g Sc he d ule  
S u bject N o.  
D a y of 
D os e  
A n al yte  
Pl a n ne d 
Ti m e  
( h: mi n) 
De vi ati o n  
( h: mi n) Re as o n f or De vi ati o n  
< S u bject >   
< Da y # >  < A nal yte >  < Pla n ne d 
bl o o d 
s a m pli n g 
ti me > 
< De viati o n 
ti me > 
< Reas o n f or de viati o n (e. g. Diffic ult y wit h bl o o d 
s a m pli n g / S u bject u na vaila ble at sc he d ule d ti me) > 
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 4. 2. 2. 1. 1. 2.  Missi n g Bl o o d S a m ples  
S u bject N o.  
D a y of 
D os e  
A n al yte  
Pl a n ne d Ti m e  
( h: mi n) 
Re as o n f or Missi n g Bl o o d S a m ple  
< S u bject I D >  < Da y # >   
< A nal yte >   
< Pla n ne d bl o o d 
s a m pli n g ti me > 
< Reas o n f or missi n g bl o o d s a m ple >  
<I ns ert as 
ma n y r o ws as 
dee me d 
necess ar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 2  of 1 4 3  
1 4. 2. 2. 1. 1. 3.  Ot h er I m p ort a nt Pr ot oc ol De vi ati o ns  
S u bject N o.   
D a y of D ose   
A n al yte   C ate g or y   
Des cri pti o n  
< S u bject I D >   
< Da y # >   
< A nal yte >  < De viati o n 
cate g or y > 
< Des cri pti o n of de viati o n >  
<I ns ert as ma n y 
r o ws as dee me d 
necess ar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 3  of 1 4 3  
1 4. 2. 2. 1. 2.  Pl as m a C o n ce ntr ati o ns  
1 4. 2. 2. 1. 2. 1.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns F oll o wi n g 
Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  3 
1 4. 2. 2. 1. 2. 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns F oll o wi n g 
Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 1. 2. 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns F oll o wi n g 
Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 1. 2. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4) : I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 2. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 1. 2. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bjects 3 
1 4. 2. 2. 1. 2. 7.  Gi vi n ost at M et a b oli te (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 2. 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 1. 2. 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bjects 3 
1 4. 2. 2. 1. 2. 1 0.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 2. 1 1.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 1. 2. 1 2.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics o f Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bjects 3 
1 4. 2. 2. 1. 2. 1 3.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at  ( D a y 1) 3 
1 4. 2. 2. 1. 2. 1 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 1. 2. 1 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bjects 3 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 4  of 1 4 3  
3 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
Pre -d os e  
 Ti m e P ost -D os e ( h)  
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x
< S u bject I D >  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x  
G me a n  (< u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  (< u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G S D ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
S D ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % CI L o wer ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G me a n  9 5 % CI U p per ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI L o wer ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI U p per ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M e dia n ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
Mi ni m u m ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M a xi m u m ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A
m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d De viati o n; G C V % –  Ge o metric C oefficie nt of 
Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per –  U p per Li mit 
of t he 9 5 % C o nfi de nce I nter val f or t he Arit h met ic Mea n. 
B L Q  –  Bel o w  t he Li mit  of  Q ua ntificati o n  ( L L O Q = < L L O Q >  < u nits C > ) of  t he assa y (ta ke n as missi n g f or t he calc ulati o n of l o g-tra nsf or me d statistics a n d as zer o f or t he calc ulati o n 
of t he re mai ni n g s u m mar y statistics)  
N D –  N ot D o ne  
Pr o gr a m:  < S A S Pr o g ra m > 
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 5  of 1 4 3  
1 4. 2. 2. 1. 2. 1 6.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) 4 
1 4. 2. 2. 1. 2. 1 7.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns 
F oll o wi n g M ulti ple -D os e A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  M ale S u bje cts 
4 
1 4. 2. 2. 1. 2. 1 8.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a C o nc e ntr ati o ns 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Fe m ale S u bjects 4 
1 4. 2. 2. 1. 2. 1 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) 4 
1 4. 2. 2. 1. 2. 2 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 2 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi v i n ost at ( D a y 9  t o D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 2 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) 4 
1 4. 2. 2. 1. 2. 2 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  M ale 
S u b jects 4 
1 4. 2. 2. 1. 2. 2 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 2 5.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) 4 
1 4. 2. 2. 1. 2. 2 6.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 2 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 2 8.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) 4 
1 4. 2. 2. 1. 2. 2 9.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 6  of 1 4 3  
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 2. 3 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
C o n ce ntr ati o ns F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Fe m ale 
S u bjects 4 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 7  of 1 4 3  
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
Pre -D os e  
Ti m e P ost -D a y 1 3 D os e ( h)  
D a y 9   
D a y 1 0   
D a y 1 1   
D a y 1 2   
D a y 1 3   
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x
< S u bject I D >  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x  
G me a n  (< u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  (< u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G S D ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
S D ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % CI L o wer ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G me a n  9 5 % CI U p per ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI L o wer ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI U p per ( < u nits C > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M e dia n ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
Mi ni m u m ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M a xi m u m ( < u nits C > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d De viati o n; G C V % –  Ge o metric C oefficie nt of 
Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per –  U p per Li mit 
of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.  
B L Q  –  Bel o w  t he Li mit  of  Q ua ntificati o n  ( L L O Q = < L L O Q >  < u nits C > ) of  t he assa y (ta ke n as missi n g f or t he calc ulati o n of l o g-tra nsf or me d statistics a n d as zer o f or t he calc ulati o n 
of t he re mai ni n g s u m mar y statistics) 
N D –  N ot D o ne  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 8  of 1 4 3  
1 4. 2. 2. 1. 3.  Pl as m a P h ar m ac o ki n etic P ar a meters  
1 4. 2. 2. 1. 3. 1.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 3. 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 1. 3. 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 1. 3. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a m eters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 3. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 3. 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr at i o n of Gi vi n ost at ( D a y 1) –  Fe m ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 1 0.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 1. 3. 1 1.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 1 2.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n e tic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale 
S u bjects 3 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  7 9  of 1 4 3  
1 4. 2. 2. 1. 3. 1 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 3 
1 4. 2. 2. 1. 3. 1 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale 
S u bjects 3 
1 4. 2. 2. 1. 3. 1 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a  a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale 
S u bjects  4 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
C m a x  
(< u nits C > ) 
T m a x  
( h) 
A U C 0 -t 
(< u nits A > ) 
A U C 0 - 
(< u nits A > ) 
% A U C
e xtr a p 
( %) 
λ z 
( 1/ h) 
t1/ 2  
( h) 
< S u bject I D >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x   
x x   
x x   
x x   
x x   
x x   
x x  
G me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M e dia n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
Mi ni m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M a xi m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI  L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 0  of 1 4 3  
1 4. 2. 2. 1. 3. 1 6.  Pl as m a M et a b olic R ati o s f or Gi vi n ost at M et a b olite s (I T F 2 3 7 4, I T F 2 3 75, I T F 2 4 4 0 a n d 
I T F 2 5 6 3) F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  
S u bject N o.  
I T F 2 3 7 4 
I T F 2 3 75  
I T F 24 4 0  
I T F 25 6 3  
< S u bject I D >  
x x. x x
x x. x x
x x. x x
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
G me a n  
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  
x x. x x
x x. x x
x x. x x
x x. x x
G S D  
x x. x x
x x. x x
x x. x x
x x. x x
S D  
x x. x x
x x. x x
x x. x x
x x. x x
G C V %  
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI L o wer   
x x. x x
x x. x x
x x. x x
x x. x x
G me a n  9 5 % CI U p per   
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  9 5 % CI L o wer   
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  9 5 % CI U p per   
x x. x x
x x. x x
x x. x x
x x. x x
M e dia n  
x x. x x
x x. x x
x x. x x
x x. x x
Mi ni m u m  
x x. x x
x x. x x
x x. x x
x x. x x
M a xi m u m  
x x. x x
x x. x x
x x. x x
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 1  of 1 4 3  
1 4. 2. 2. 1. 3. 1 7.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 1. 3. 1 8.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bje cts 
4 
1 4. 2. 2. 1. 3. 1 9.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Pl as m a P h ar m ac o ki netic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bjects 4 
1 4. 2. 2. 1. 3. 2 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 1. 3. 2 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics o f Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 1. 3. 2 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 6.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 1. 3. 2 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nist r ati o n of Gi vi n ost at ( D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 8.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 2 9.  Gi vi n ost at  M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 1. 3. 3 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 2  of 1 4 3  
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale 
S u bjects 4 
1 4. 2. 2. 1. 3. 3 1.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Pl as m a 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale 
S u bjects 4 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
C m a x,ss  
(< u nits C > ) 
T m a x,ss  
( h) 
A U C 0 -τ,ss 
(< u nits A > ) 
A U C 0 -t 
(< u nits A > ) 
A U C 0 - 
(< u nits A > ) 
λ z 
( 1/ h) 
t1/ 2  
( h) 
C L ss/ F 
( L/ h) 
V D / F 
( L) 
< S u bject 
I D > 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x  
G me a n   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
A me a n   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
G S D   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
S D   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
G C V %   
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %   
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % 
CI L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
G me a n  9 5 % 
CI U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % 
CI L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % 
CI U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
M e dia n   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
Mi ni m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
M a xi m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x 
x x. x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Me a n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 3  of 1 4 3  
1 4. 2. 2. 1. 3. 3 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Acc u m ul ati o n  I n de x 4 
1 4. 2. 2. 1. 3. 3 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Acc u m ul ati o n I n de x –  M ale 
S u bjects  4 
1 4. 2. 2. 1. 3. 3 4.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Acc u m ul ati o n I n de x –  Fe m ale 
S u bjects  4 
1 4. 2. 2. 1. 3. 3 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n  I n d e x 4 
1 4. 2. 2. 1. 3. 3 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Des cri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  M ale S u bje cts  4 
1 4. 2. 2. 1. 3. 3 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  Fe m ale S u bje cts  4 
1 4. 2. 2. 1. 3. 3 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics  of 
Ac c u m ul ati o n  I n d e x 4 
1 4. 2. 2. 1. 3. 3 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  M ale S u bje cts  4 
1 4. 2. 2. 1. 3. 4 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  Fe m ale S u bje c ts 4 
1 4. 2. 2. 1. 3. 4 1.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n  I n d e x 4 
1 4. 2. 2. 1. 3. 4 2.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  M ale S u bje cts  4 
1 4. 2. 2. 1. 3. 4 3.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  Fe m ale S u bje cts  4 
1 4. 2. 2. 1. 3. 4 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n  I n d e x 4 
1 4. 2. 2. 1. 3. 4 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  M ale S u bje cts  4 
1 4. 2. 2. 1. 3. 4 6.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
Ac c u m ul ati o n I n d e x –  Fe m ale S u bje cts  4 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 4  of 1 4 3  
4 T o be ge ner ate d  as f oll o ws:  
S u bject N o.  
C m a x  
A U C  
< S u bject I D >  
x x. x x
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
A me a n  
x x. x x
x x. x x
S D  
x x. x x
x x. x x
S E  
x x. x
x x. x
M e dia n  
x x. x x
x x. x x
Mi ni m u m  
x x. x x
x x. x x
M a xi m u m  
x x. x x
x x. x x
n –  N u m ber of S u bjects; A m e a n –  Arit h metic Mea n; S D –  Sta n dar d De viati o n; S E –  Sta n dar d Err or.  
N C  –  N ot  Calc ulate d  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 5  of 1 4 3  
1 4. 2. 2. 1. 3. 4 7.  Pl as m a M et a b olic R ati o s f or Gi vi n ost at M et a b olite s (I T F 2 3 7 4, I T F 2 3 75, I T F 2 4 4 0 a n d 
I T F 2 5 6 3) F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3 ) 
S u bject N o.  
I T F 2 3 7 4 
I T F 2 3 75  
I T F 24 4 0  
I T F 25 6 3  
< S u bject I D >  
x x. x x
x x. x x
x x. x x
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
G me a n  
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  
x x. x x
x x. x x
x x. x x
x x. x x
G S D  
x x. x x
x x. x x
x x. x x
x x. x x
S D  
x x. x x
x x. x x
x x. x x
x x. x x
G C V %  
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI L o wer   
x x. x x
x x. x x
x x. x x
x x. x x
G me a n  9 5 % CI U p per   
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  9 5 % CI L o wer   
x x. x x
x x. x x
x x. x x
x x. x x
A me a n  9 5 % CI U p per   
x x. x x
x x. x x
x x. x x
x x. x x
M e dia n  
x x. x x
x x. x x
x x. x x
x x. x x
Mi ni m u m  
x x. x x
x x. x x
x x. x x
x x. x x
M a xi m u m  
x x. x x
x x. x x
x x. x x
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 6  of 1 4 3  
1 4. 2. 2. 1. 4.  L o g -Li n e ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n  
1 4. 2. 2. 1. 4. 1.  Gi vi n ost at: L o g -Li n e ar Re gr essi o n P ar a mete rs f or λ z Esti m ati o n F oll o wi n g Si n gle -D ose 
A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 6 
1 4. 2. 2. 1. 4. 2.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 6 
1 4. 2. 2. 1. 4. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 6 
1 4. 2. 2. 1. 4. 4.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 6 
1 4. 2. 2. 1. 4. 5.  Gi vi n ost at  M et a b olite (I T F 2 5 6 3 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 6 
1 4. 2. 2. 1. 4. 6.  Gi vi n ost at: L o g -Li n e ar Re gr essi o n P ar a mete rs f or λ z Esti m ati o n F oll o wi n g M ulti ple -D ose 
A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  6 
1 4. 2. 2. 1. 4. 7.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4): L o g -Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  6 
1 4. 2. 2. 1. 4. 8.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g M ulti p le-D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  6 
1 4. 2. 2. 1. 4. 9.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  6 
1 4. 2. 2. 1. 4. 1 0.  Gi vi n ost at  M et a b olite (I T F 2 5 6 3 ): L o g-Li ne ar Re gressi o n P ar a mete rs f or λ z Esti m ati o n 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  6 
6 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
L o wer T LI N  
( h) 
U p per T LI N  
( h) 
N o. of Ti m e P oi nts   
R S Q  
< S u bject I D >  
x x. x x
x x. x x
x x  
x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
L o wer  T LI N  –  L o wer  Ti me  P oi nt  Use d  i n Re gressi o n  A nal ysis; U p per  T LI N  –  U p per  Ti me  P oi nt  Use d  i n Re gressi o n  A nal ysis; 
R S Q  –  G o o d ness of Fit f or t he Ter mi nal Eli mi nati o n P hase  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 7  of 1 4 3  
1 4. 2. 2. 2.  Uri n ar y  P h ar m ac o ki netic D at a  
1 4. 2. 2. 2. 1.  De vi ati o ns fr o m Uri ne  S a m pli n g S c h e d ule  
1 4. 2. 2. 2. 1. 1.  Missi n g Uri ne  S a m ples  
S u bject N o.  
D a y of 
D os e  
Pl a n ne d St art Ti m e  
( h: mi n) 
Pl a n ne d E n d Ti m e  
( h: mi n) 
Re as o n f or Missi n g Uri ne S a m ple  
< S u bject I D >  < Da y # >   
< Pla n ne d bl o o d 
s a m pli n g ti me > 
< Pla n ne d bl o o d 
s a m pli n g ti me > 
< Reas o n f or missi n g bl o o d s a m ple >  
<I ns ert as 
ma n y r o ws as 
dee me d 
necess ar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 8  of 1 4 3  
1 4. 2. 2. 2. 2.  Uri n ar y E xc reti o n Pr ofile  
1 4. 2. 2. 2. 2. 1.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile  
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bje cts 
3 
1 4. 2. 2. 2. 2. 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile 
F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale  S u bjects 3 
1 4. 2. 2. 2. 2. 4.  Gi vi n ost at M et a b olit e (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile  F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr at i o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile  F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 8.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): I n di vi d ual D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 9.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g  Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 1 0.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile  F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 1 1.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 1 2.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 1 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile  F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 1 4.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E x c r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 1 5.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 ) –  Fe m ale S u bje cts 3 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  8 9  of 1 4 3  
1 4. 2. 2. 2. 2. 1 6.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 1 7.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 1 8.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 1 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) 3 
1 4. 2. 2. 2. 2. 2 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 2 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti v e St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 2 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) 3 
1 4. 2. 2. 2. 2. 2 3.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atis tics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 2 4.  Gi vi n ost at M et a b olite ( I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 2 5.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) 3 
1 4. 2. 2. 2. 2. 2 6.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 2 7.  G i vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  Fe m ale S u bje cts 3 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 0  of 1 4 3  
1 4. 2. 2. 2. 2. 2 8.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics C u m ul ati ve 
A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
3 
1 4. 2. 2. 2. 2. 2 9.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 3 0.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1) –  Fe m ale S u bje cts 3 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
Pre -D os e 
( D a y -1)  
P ost -D a y 1 D os e  
0 h –  1 2 h  
1 2 h –  2 4 h  2 4 h –  3 6 h  3 6 h –  4 8 h  4 8 h –  7 2 h  7 2 h –  9 6 h  
< S u bject I D >  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y > 
n  
x x   
x x   
x x   
x x   
x x   
x x   
x x  
G me a n  (< u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  (< u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G S D ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
S D ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % CI L o wer ( < u nits > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G me a n  9 5 % CI U p per ( < u nits > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI L o wer ( < u nits > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI U p per ( < u nits > )  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M e dia n ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
Mi ni m u m ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M a xi m u m ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N D  –  N ot  D o ne
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 1  of 1 4 3  
1 4. 2. 2. 2. 2. 3 1.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 3 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile 
F oll o wi n g M ulti ple -D ose  A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 3 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y E xc reti o n Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 3 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4 ): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 3 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 3 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 3 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 3 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 3 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n o st at ( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 4 0.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 4 1.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 4 2.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 4 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 4 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n o st at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 4 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bje cts 3 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 2  of 1 4 3  
1 4. 2. 2. 2. 2. 4 6.  Gi vi n ost at: I n di vi d u al D at a a n d De sc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 4 7.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 4 8.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of C u m ul ati ve A m o u nt Uri n ar y 
E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 4 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) 3 
1 4. 2. 2. 2. 2. 5 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Desc ri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 5 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc r eti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 5 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr at i o n of Gi vi n ost at 
( D a y 1 3) 3 
1 4. 2. 2. 2. 2. 5 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 5 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  Fe m ale S u bje cts 3 
1 4. 2. 2. 2. 2. 5 5.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) 3 
1 4. 2. 2. 2. 2. 5 6.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 5 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  Fe m ale S u bje cts 3 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 3  of 1 4 3  
1 4. 2. 2. 2. 2. 5 8.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics C u m ul ati ve 
A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
3 
1 4. 2. 2. 2. 2. 5 9.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  M ale S u bjects 
3 
1 4. 2. 2. 2. 2. 6 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of 
C u m ul ati ve A m o u nt Uri n ar y E xc reti o n Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 1 3) –  Fe m ale S u bje cts 3 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
P ost -D a y 1 3 D os e  
0 h –  1 2 h  
1 2 h –  2 4 h  2 4 h –  3 6 h  3 6 h –  4 8 h  4 8 h –  7 2 h  7 2 h –  9 6 h  
< S u bject I D >  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x   
x x   
x x   
x x   
x x   
x x  
G me a n  (< u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  (< u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G S D ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
S D ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
C V %  
x x. x 
x x. x 
x x. x 
x x. x 
x x. x 
x x. x
G me a n  9 5 % CI L o wer ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
G me a n  9 5 % CI U p per ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI L o wer ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
A me a n  9 5 % CI U p per ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M e dia n ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
Mi ni m u m ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
M a xi m u m ( < u nits > ) 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Me a n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N D  –  N ot  D o ne
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 4  of 1 4 3  
1 4. 2. 2. 2. 3.  Uri n ar y P h ar m ac o ki netic P ar a mete rs  
1 4. 2. 2. 2. 3. 1.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
4 
1 4. 2. 2. 2. 3. 2.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  M ale S u bjects  4 
1 4. 2. 2. 2. 3. 3.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Fe m ale  S u bje cts  4 
1 4. 2. 2. 2. 3. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
4 
1 4. 2. 2. 2. 3. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Fe m ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
4 
1 4. 2. 2. 2. 3. 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Fe m ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 1 0.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pt i ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
4 
1 4. 2. 2. 2. 3. 1 1.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi n istr ati o n of Gi vi n ost at ( D a y 1) –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 1 2.  Gi vi n ost at M et a b olite ( I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Fe m ale 
S u bjects  4 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 5  of 1 4 3  
1 4. 2. 2. 2. 3. 1 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1) 
4 
1 4. 2. 2. 2. 3. 1 4.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of U ri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 1 5.  Gi vi n ost at M et a b olite ( I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g Si n gle -D ose A d mi nist r ati o n of Gi vi n ost at ( D a y 1)  –  Fe m ale 
S u bjects  4 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
R m a x  
(< u nits > ) 
t um a x  
( h) 
A mt C U M  
(< u nits > ) 
A U R C 0 -t 
(< u nits > ) 
R E C % 
( %) 
C L R / F 
( L/ h) 
< S u bject I D >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
<I ns ert as ma n y r o ws as dee me d necessar y > 
n  
x x  
x x  
x x  
x x  
x x  
x x  
G me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
M e dia n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
Mi ni m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
M a xi m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I n ter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 6  of 1 4 3  
1 4. 2. 2. 2. 3. 1 6.  Pe rc e nt a ge of D ose  Re c o ve re d i n Uri n e  f or Gi vi n ost at a n d Gi vi n ost at M et a b olite s 
(I T F 2 3 7 4, I T F 2 3 75, I T F 2 4 4 0 a n d I T F 2 5 6 3) F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 
1)  
S u bject N o.   
Gi vi n ost at   
I T F 2 3 7 4  
I T F 2 3 75   
I T F 24 4 0   
I T F 25 6 3   
T ot al  
< S u bject I D >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
x x  
x x  
G me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI 
L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G me a n  9 5 % CI 
U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI 
L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI 
U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M e dia n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
Mi ni m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M a xi m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Me a n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
T otal c orres p o n ds t o t he s u m of perce nta ge of d ose rec o vere d i n uri ne  f or all a nal ytes
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 7  of 1 4 3  
1 4. 2. 2. 2. 3. 1 7.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 2. 3. 1 8.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  M ale S u bje cts  4 
1 4. 2. 2. 2. 3. 1 9.  Gi vi n ost at: I n di vi d u al D at a a n d Desc ri pti ve St atistics of Uri n ar y P h ar m ac o ki n etic 
P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Fe m ale S u bjects  4 
1 4. 2. 2. 2. 3. 2 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 4 
1 4. 2. 2. 2. 3. 2 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 2 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Fe m ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 2 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descr i pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 2. 3. 2 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D o se A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 2 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Fe m ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 2 6.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 2. 3. 2 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistic s of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 2 8.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Fe m ale 
S u bjects  4 
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 8  of 1 4 3  
1 4. 2. 2. 2. 3. 2 9.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o w i n g M ulti ple-D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3) 
4 
1 4. 2. 2. 2. 3. 3 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  M ale 
S u bjects  4 
1 4. 2. 2. 2. 3. 3 1.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al D at a a n d Descri pti ve St atistics of Uri n ar y 
P h ar m ac o ki n etic P ar a meters F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Fe m ale 
S u bjects  4 
4 T o be ge ner ate d as f oll o ws:  
S u bject N o.  
R m a x  
(< u nits > ) 
t um a x  
( h) 
A mt C U M  
(< u nits > ) 
A U R C 0 -t 
(< u nits > ) 
R E C % 
( %) 
C L R / F 
( L/ h) 
< S u bject I D >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
x x  
x x  
G me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
G me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  9 5 % CI L o wer   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
A me a n  9 5 % CI U p per   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
M e dia n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
Mi ni m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
M a xi m u m  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x. x x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metric Mea n; G m e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n.
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  9 9  of 1 4 3  
1 4. 2. 2. 2. 3. 3 2.  Pe rc e nt a ge of D ose Re c o ve re d i n Uri n e f or Gi vi n ost at a n d Gi vi n ost at M et a b olite s 
(I T F 2 3 7 4, I T F 2 3 75, I T F 2 4 4 0 a n d I T F 2 5 6 3) F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at 
( D a y 13 ) 
S u bject N o.   
Gi vi n ost at   
I T F 2 3 7 4  
I T F 2 3 75   
I T F 24 4 0   
I T F 25 6 3   
T ot al  
< S u bject I D >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  
x x  
x x  
x x  
x x  
x x  
x x  
G me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
S D  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
C V %  
x x. x
x x. x
x x. x
x x. x
x x. x
x x. x
G me a n  9 5 % CI 
L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
G me a n  9 5 % CI 
U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI 
L o wer  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
A me a n  9 5 % CI 
U p per  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M e dia n  
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
Mi ni m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
M a xi m u m   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
n –  N u m ber of S u bjects; G m e a n –  Ge o metric Mea n; A m e a n –  Arit h metic Mea n; G S D –  Ge o metric Sta n dar d De viati o n; S D –  Sta n dar d 
De viati o n; G C V % –  Ge o metric C oefficie nt of Variati o n; C V % –  C oefficie nt of Variati o n; G m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 
9 5 % C o nfi de nce I nter val f or t he Ge o metr ic Mea n; Gm e a n  9 5 % CI U p per –  U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t he 
Ge o metric Mea n; A m e a n  9 5 % CI L o wer –  L o wer Li mit of t he 9 5 % C o nfi de nce I nter val f or t he Arit h metic Mea n; A m e a n  9 5 % CI U p per 
– U p per Li mit of t he 9 5 % C o nfi de nce I nter val f or t h e Arit h metic Mea n.
T otal c orres p o n ds t o t he s u m of perce nta ge of d ose rec o vere d i n uri ne  f or all a nal ytes
N C  –  N ot  Calc ulate d
Pr o gr a m:  < S A S Pr o gra m >
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 0  of 1 4 3  
1 4. 2. 2. 3.  Pl as m a C o n ce ntr ati o n  Vers us  Ti me Pr ofiles of All S u bje cts 
1 4. 2. 2. 3. 1.  Gi vi n ost at: Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofiles of All S u bjects F oll o wi n g Si n gle -
D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Li n e ar Sc ale  
1 4. 2. 2. 3. 2.  Gi vi n ost at : Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofiles of All S u bjects F oll o wi n g M ulti ple -
D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Li n e ar Sc ale  
1 4. 2. 2. 3. 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 4) : Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Li n e ar Sc ale  
1 4. 2. 2. 3. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Li ne ar S c ale  
1 4. 2. 2. 3. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5) : Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bje cts F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Li n e ar Sc ale  
1 4. 2. 2. 3. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Li ne ar S c ale  
1 4. 2. 2. 3. 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0) : Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Li n e ar Sc ale  
1 4. 2. 2. 3. 8.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile s of All 
S u bjects F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Li ne ar S c ale  
1 4. 2. 2. 3. 9.  Gi vi n ost at M et a b olite (I T F 2 5 6 3) : Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g Si n gle -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1)  –  Li n e ar S c ale 
1 4. 2. 2. 3. 1 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles of All 
S u bjects F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 1 3)  –  Li ne ar S c ale  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 1  of 1 4 3  
1 4. 2. 2. 4.  I n di vi d u al Pl as m a C o nc e ntr ati o n  Vers us  Ti me Pr ofiles 
1 4. 2. 2. 4. 1.  Gi vi n ost at: I n di vi d u al Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose 
( D a y 1) a n d M ulti ple-D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar S c ale  
1 4. 2. 2. 4. 2.  Gi vi n ost at: I n di vi d u al Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose 
( D a y 1) a n d M ulti ple-D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  S e mi -L o g arit h mic S c ale  
1 4. 2. 2. 4. 3.  Gi vi n ost at: I n di vi d u al Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar S c ale  
1 4. 2. 2. 4. 4.  Gi vi n ost at: I n di vi d u al Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g M ulti ple -D ose 
A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Se mi -L o g arit h mic Sc ale  
1 4. 2. 2. 4. 5.  Gi vi n ost at: I n di vi d u al Tr o u g h Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofile F oll o wi n g 
M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li n e ar S c ale  
1 4. 2. 2. 4. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 4. 7.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3 ) A d mi nistr ati o n of Gi vi n ost at –  Se mi -
L o g arit h mic S c ale  
1 4. 2. 2. 4. 8.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 9.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  S e mi -L o g arit h mic S c ale  
1 4. 2. 2. 4. 1 0.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Tr o u g h Pl as m a C o n ce ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g  M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 1 1.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 4. 1 2.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3 ) A d mi nistr ati o n of Gi vi n ost at –  Se mi -
L o g arit h mic S c ale  
1 4. 2. 2. 4. 1 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 1 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  S e mi -L o g arit h mic S c ale  
1 4. 2. 2. 4. 1 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Tr o u g h Pl as m a C o n ce ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g  M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 2  of 1 4 3  
1 4. 2. 2. 4. 1 6.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar  Sc ale  
1 4. 2. 2. 4. 1 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Se mi -
L o g arit h mic S c ale  
1 4. 2. 2. 4. 1 8.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 1 9.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  S e mi -L o g arit h mic S c ale  
1 4. 2. 2. 4. 2 0.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Tr o u g h Pl as m a C o n ce ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 2 1.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 4. 2 2.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Se mi -
L o g arit h mic S c ale  
1 4. 2. 2. 4. 2 3.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
1 4. 2. 2. 4. 2 4.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Pl as m a C o n c e ntr ati o n Vers us  Ti me Pr ofile 
F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  S e mi -L o g arit h mic S c ale  
1 4. 2. 2. 4. 2 5.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Tr o u g h Pl as m a C o n ce ntr ati o n Vers us  Ti me 
Pr ofile F oll o wi n g M ulti ple -D ose A d mi nistr ati o n of Gi vi n ost at ( D a y 9  t o D a y 1 3) –  Li ne ar S c ale  
P P D


I TF/ 2 3 5 7/ 5 5  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 3  of 1 4 3  
1 4. 2. 2. 5.  I n divi d u al Uri n ar y E xc reti o n Vers us  Ti me Pr ofiles 
1 4. 2. 2. 5. 1.  Gi vi n ost at: I n di vi d u al Uri n ar y E xc reti o n Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) 
a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 2.  Gi vi n ost at: I n di vi d u al C u m ul ati ve A m o u nt Uri n ar y E xc r eti o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 3.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al Uri n ar y E xc r eti o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n g le-D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 4.  Gi vi n ost at M et a b olite (I T F 2 3 7 4): I n di vi d u al C u m ul ati ve A m o u nt Uri n ar y E xcr eti o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  
Li n e ar Sc ale  
1 4. 2. 2. 5. 5.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al Uri n ar y E xc r eti o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 6.  Gi vi n ost at M et a b olite (I T F 2 3 7 5): I n di vi d u al C u m ul ati ve A m o u nt Uri n ar y E xcr eti o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  
Li n e ar Sc ale  
1 4. 2. 2. 5. 7.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al Uri n ar y E xc r eti o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 8.  Gi vi n ost at M et a b olite (I T F 2 4 4 0): I n di vi d u al C u m ul ati ve A m o u nt Uri n ar y E xcr eti o n Vers us  
Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  
Li n e ar Sc ale  
1 4. 2. 2. 5. 9.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al Uri n ar y E xc r eti o n Vers us  Ti me Pr ofile 
F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of Gi vi n ost at –  Li n e ar Sc ale  
1 4. 2. 2. 5. 1 0.  Gi vi n ost at M et a b olite (I T F 2 5 6 3): I n di vi d u al C u m ul ati ve A m o u nt Uri n ar y E xcr eti o n 
Vers us  Ti me Pr ofile F oll o wi n g Si n gle -D ose ( D a y 1) a n d M ulti ple -D ose ( D a y 1 3) A d mi nistr ati o n of 
Gi vi n ost at –  Li n e ar S c ale  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 4  of 1 4 3  
1 4. 2. 3.  S A F E T Y D A T A  –  P A R T 3  
1 4. 2. 3. 1.  A d verse E ve nts  
1 4. 2. 3. 1. 1.  Pr e -Tr e at me nt A d verse E ve nts  
S u bject N o.  
S O C  
Me d D R A P T  
( Re p orte d Ter m) 
S A E ?  
( Yes/ N o) 
A d vers e E ve nt D ate a n d Ti m e  
M a xi m al 
Se verit y  
C a us alit y  
Me dic ati o n  
Re q uire d ?  
O utc o m e  
St art  
E n d  
< S u bject 
I D > 
< S O C >  
< T E A E i n M e d D R A P T > 
( < T E A E re p orte d ter m >) 
< Yes / N o >  D D M M M Y Y Y Y -
h h: m m >  
D D M M M Y Y Y Y -
h h m m >  
< M a xi mal 
Se verit y of t he 
A E >  
< Ca usalit y of 
t he A E > 
< Yes/ N o >   
< O utc o me of 
t he A E > 
<I ns ert as ma n y r o ws as dee me d necessar y >  
S O C –  S yste m Or ga n Class; Me d D R A –  Me dical Dicti o nar y f or Re g ulat or y Acti vities ; P T –  Preferre d Ter m; S A E –  Seri o us A d verse E ve nt 
N K  –  N ot  K n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 5  of 1 4 3  
1 4. 2. 3. 1. 2.  Tr e at me nt -E mer ge nt A d verse E ve nts (I)  
S u bject N o.  D a y of D ose  
S O C  
Me d D R A P T  
( Re p orte d Ter m) 
S A E ?  
( Yes/ N o) 
L ast Tre at m e nt  
D ate a n d Ti m e  
A d vers e E ve nt D ate a n d Ti m e  
St art  
St art  
< S u bject I D >  
< Da y # >  
< S O C >  
< T E A E i n M e d D R A P T > 
( < T E A E re p orte d ter m >) 
< Yes / N o >  
< D D M M M Y Y Y Y h h m m >  < D D M M M Y Y Y Y h h: m m >  < D D M M M Y Y Y Y h h: m m >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
S O C –  S yste m Or ga n Class; Me d D R A –  Me dical Dicti o nar y f or Re g ulat or y Acti vities ; P T –  Preferre d Ter m; S A E –  Seri o us A d verse E ve nt 
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 4. 2. 3. 1. 3.  Tr e at me nt -E mer ge nt A d verse E ve nts (II) 
S u bject N o.  D a y of D ose  
S O C  
Me d D R A P T  
( Re p orte d Ter m) 
M a xi m al Se verit y   
C a us alit y  
Me dic ati o n  
Re q uire d ?  
O utc o m e  
< S u bject I D >  
< Da y # >   
< S O C >  
< T E A E i n M e d D R A P T > 
( < T E A E re p orte d ter m >) 
< M a xi mal Se verit y 
of t he T E A E >  
< Ca usalit y of t he 
T E A E >  
< Yes/ N o >  
< O utc o me of t he T E A E >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
S O C –  S yste m Or ga n Class; Me d D R A –  Me dical Dicti o nar y f or Re g ulat or y Acti vities ; P T –  Preferre d Ter m; S A E –  Seri o us A d verse E ve nt 
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 6  of 1 4 3  
1 4. 2. 3. 2.  Vit al Si g ns  
1 4. 2. 3. 2. 1.  Descri pti ve St atistics of Vit al Si g ns P ar a meters 
9 
1 4. 2. 3. 2. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of Vit al Si g ns P ar a mete rs 
9 
1 4. 2. 3. 2. 3.  S hifts i n Vit al Si g ns P ar a mete rs 1 0 
1 4. 2. 3. 3.  1 2 -Le a d E C G  
1 4. 2. 3. 3. 1.  Descri pti ve St atistics of 1 2 -Le a d E C G P ar a mete rs 9 
1 4. 2. 3. 3. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of 1 2 -Le a d E C G P ar a mete rs 9 
1 4. 2. 3. 3. 3.  S hifts i n 1 2 -Le a d E C G P ar a mete rs 1 0 
1 4. 2. 3. 4.  He m at ol o g y  
1 4. 2. 3. 4. 1.  Descri pti ve St atistics of He m at ol o g y P ar a meters 
9 
1 4. 2. 3. 4. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of He m at ol o g y P ar a meters 
9 
1 4. 2. 3. 4. 3.  S hif ts i n He m at ol o g y P ar a mete rs 1 0 
1 4. 2. 3. 5.  Bi oc h e mistr y  
1 4. 2. 3. 5. 1.  Descri pti ve St atistics of Bi oc h e mistr y P ar a meters 
9 
1 4. 2. 3. 5. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of Bi oc h e mistr y P ar a meters 
9 
1 4. 2. 3. 5. 3.  S hifts i n Bi oc he mistr y P ar a mete rs 1 0 
1 4. 2. 3. 6.  C o a g ul ati o n  
1 4. 2. 3. 6. 1.  Descri pti ve St atistics of C o a g ul ati o n P ar a mete rs 9 
1 4. 2. 3. 6. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of C o a g ul ati o n P ar a meters 
9 
1 4. 2. 3. 6. 3.  S hifts i n C o a g ul ati o n P ar a meters 1 0 
1 4. 2. 3. 7.  Uri n al ysis  
1 4. 2. 3. 7. 1.  Descri pti ve St atistics of Uri n al ysis P ar a mete rs 
9 
1 4. 2. 3. 7. 2.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of Uri n al ysis P ar a mete rs 
9 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 7  of 1 4 3  
1 4. 2. 3. 7. 3.  S hifts i n Uri n al ysis P ar a meters 1 0 
9 T o be ge ner ate d as f oll o ws:  
P ar a m eter   
St u d y D a y   
Pr ot oc ol Ti m e   
n  
Me a n   
S D   
S E  Me di a n  Mi ni m u m  M a xi m u m  
< Para meter ( u nit) >  < Da y >  
< Pr ot oc ol Ti me >   x x  
x. x x x  
x. x x x  x. x x x  x. x x x   
x. x x x 
x. x x x
< Pr ot oc ol Ti me >  
< Pr ot oc ol Ti me >  
< Pr ot oc ol Ti me >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  –  n u m ber  of  s u bjects; S D  –  Sta n dar d  De viati o n; S E –  Sta n dar d Err or  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 0 T o be ge ner ate d as f oll o ws:  
P ar a m eter   
St u d y D a y   
Pr ot oc ol Ti m e  
Cl assific ati o n  
Nr. of S u bjects  
B as eli ne  
P ost -B as eli ne 
Ass ess m e nt  
< Para meter ( u nit) >  < Da y >   
< Pr ot oc ol Ti me >   
< L o w/  
N or mal/  
Hi g h >  
< L o w/  
N or mal/  
Hi g h >  
x x  
< Pr ot oc ol Ti me >   
< L o w/  
N or mal/  
Hi g h >  
< L o w/  
N or mal/  
Hi g h >  
x x  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 8  of 1 4 3  
1 4. 2. 3. 8.  B o d y Wei g ht  
1 4. 2. 3. 8. 1.  Descri pti ve St atistics of B o d y Wei g ht  9 
1 4. 2. 3. 8. 2.  Descri pti ve St atistics of B o d y Wei g ht –  M ale S u bje cts  9 
1 4. 2. 3. 8. 3.  Descri pti ve St atistics of B o d y Wei g ht –  Fe m ale S u bje cts  9 
1 4. 2. 3. 8. 4.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of B o d y Wei g ht  9 
1 4. 2. 3. 8. 5.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of B o d y Wei g ht –  M ale S u bjects  9 
1 4. 2. 3. 8. 6.  Descri pti ve St atistics of C h a n ge fr o m B aseli ne of B o d y Wei g ht –  Fe m ale S u bje cts  9 
9 T o be ge ner ate d as f oll o ws:  
Visit  
n   
Me a n   
S D   
S E   
Me di a n   
Mi ni m u m   
M a xi m u m  
< Da y >  
x x   
x. x x x 
x. x x x 
x. x x x 
x. x x x 
x. x x x 
x. x x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
n  –  n u m ber  of  s u bjects; S D  –  Sta n dar d  De viati o n; S E –  Sta n dar d Err or  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 0 9  of 1 4 3  
A. 4. 
List of S u bject D at a Listi n gs ( S e cti o n 1 6. 2 of C S R)  
A. 4. 1. 
P art 3  
1 6. 2. 1.  P A R T 3  
1 6. 2. 1. 1.  S u bject Dis p ositi o n  
1 6. 2. 1. 1. 1.  S u bject Dis p ositi o n  
Scree ni n g 
N o.  
D ate I C F Si g ne d  S u bject 
Eli gi ble ?  
S u bject Gi ve n 
a n U ni q ue 
S u bject N o. ?  
U ni q ue S u bject N o.  I ncl usi o n Criteri a 
N ot Met  
E xcl usi o n Criteri a 
Met  
Ot her Re as o n f or 
N o n -Eli gi bilit y  
Re as o n f or 
N o n -
R a n d o miz ati o n  
< Scree ni n g 
n u m ber >  
< D D M M M Y Y Y Y >  < Yes/ N o >  < Yes/ N o >   
< U ni q ue S u bject 
N o >  
< List all i ncl usi o n 
criteria t hat were 
n ot met >  
< List all e xcl usi o n 
criteria t hat were 
met >  
< List ot her reas o ns 
f or n o n -eli gi bilit y >  
< List reas o n f or 
n o n -ra n d o mizati o n > 
<I ns ert as ma n y r o ws as dee me d necessar y >  
I C F –  I nf or me d C o nse nt  F or m  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 0  of 1 4 3  
1 6. 2. 1. 2.  Pr ot oc ol De vi ati o ns  
1 6. 2. 1. 2. 1.  Bl o o d S a m pli n g Ti mes De vi ati o ns  
S u bject N o.  
S a m pli n g Ti m e p oi nt  
S a m pli n g D ate a n d Ti m e  
De vi ati o n Re as o n  
Sc he d ule d/ T ar get  
Act u al  
< S u bject I D >  
< Sc he d ule d Ti me or 
u ns c he d ule d >  
< D D M M M Y Y Y Y 
h h: m m >  
< D D M M M Y Y Y Y 
h h: m m >  
< Reas o n f or de viati o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 6. 2. 1. 2. 2.  Ot h er Pr ot oc ol De vi ati o ns  
S u bject N o.  Pr ot oc ol 
P h as e  
C ate g or y   
Des cri pti o n  
Cl assific ati o n  
< S u bject I D >  < Pr ot oc ol 
P has e # >  
< De viati o n 
Cate g or y >  
< Des cri pti o n of t he de viati o n >  
<I m p orta nt / N ot i m p orta nt >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 1  of 1 4 3  
1 6. 2. 1. 3.  E xcl u d e d D at a fr o m t h e P h ar m ac o ki n etic A n al ysis  
1 6. 2. 1. 3. 1.  Pl as m a C o n ce ntr ati o ns  
1 6. 2. 1. 3. 1. 1.  I n di vi d u al D at a of Pl as m a C o nc e ntr ati o ns  
S u bject N o.  D a y of 
D osi n g  
A n al yte   
Pre -d os e  
 Ti m e P ost -D os e ( h)  
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x 
x. x x
< S u bject 
I D > 
< Da y # >  
< A nal yte >   
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x 
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
B L Q  –  Bel o w  t he Li mit  of  Q ua ntificati o n  ( L L O Q = < L L O Q >  < u nits C > ) of  t he assa y 
N D  –  N ot  D o ne  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 6. 2. 1. 3. 2.  Pl as m a C o n ce ntr ati o n Vers us  Ti me Pr ofiles  
1 6. 2. 1. 3. 2. 1.  I n di vi d u al Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles –  Li n e ar Sc ale  
1 6. 2. 1. 3. 2. 2.  I n di vi d u al Pl as m a C o nc e ntr ati o n Vers us  Ti me Pr ofiles –  S e mi -L o g arit h mic Sc ale  
N ote: T hese Fi g ures will be e xtr acte d fr o m P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her . A fi g ure will be pr o d uce d f or e ac h s u bje ct wit h d at a e x cl u de d fr o m 
t he p h ar m ac oki netic a n alysis. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 2  of 1 4 3  
1 6. 2. 1. 3. 3.  Uri n e E xc re ti o n 
1 6. 2. 1. 3. 3. 1.  I n di vi d u al D at a of Pl as m a C o nc e ntr ati o ns  
S u bject N o.  D a y of 
D osi n g  
A n al yte   
Pre -d os e  
 Ti m e P ost -D os e ( h)  
0 h –  1 2 h   
1 2 h –  2 4 h   
2 4 h –  3 6 h   
3 6 h –  4 8 h   
4 8 h –  7 2 h   
7 2 h –  9 6 h  
< S u bject 
I D > 
< Da y # >  
< A nal yte >   
x x. x x 
x x. x x
x x. x x
x x. x x
x x. x x
x x. x x
x x. x x
<I ns ert as ma n y r o ws as dee me d necessar y >  
B L Q  –  Bel o w  t he Li mit  of  Q ua ntificati o n  ( L L O Q = < L L O Q >  < u nits C > ) of  t he assa y 
N D  –  N ot  D o ne  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 6. 2. 1. 3. 4.  Uri n e E xc reti o n Vers us  Ti me Pr ofiles  
1 6. 2. 1. 3. 4. 1.  Uri n e E xc reti o n Vers us  Ti me Pr ofiles  –  Li n e ar S c ale  
N ote: T hese Fi g ures will be e xtr acte d fr o m P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her . A fi g ure will be pr o d uce d f or e ac h s u bje ct wit h d at a e x cl u de d fr o m 
t he p h ar m ac oki netic a n alysis. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 3  of 1 4 3  
1 6. 2. 1. 4.  De m o gr a p hic a n d Ot h e r B aseli n e D at a  
1 6. 2. 1. 4. 1.  De m o gr a p hic D at a  
S u bject N o.   
D ate I C F Si g ne d   
D ate of Birt h   
Se x   
R ace  
A ge  
( ye ars) 
Hei g ht  
(c m) 
Wei g ht  
( k g) 
B MI  
( k g/ m2) 
< S u bject I D >   
< D D M M M Y Y Y Y >  < M M M Y Y Y Y >   
< M/ F >   < Race >  
x x   
x x x   
x x. x 
x x. x
<I ns ert as ma n y r o ws as dee me d necessar y > 
I C F –  I nf or me d C o nse nt  F or m; B MI  –  B o d y  Mass  I n de x; M –  Male; F –  Fe male  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 4  of 1 4 3  
1 6. 2. 1. 4. 2.  Fe rtilit y/ C o ntr ac e pti o n 
1 6. 2. 1. 4. 2. 1.  Fe m ale Fe rtilit y/ C o ntr ace pti o n  
S u bject N o.  
C hil d be ari n g P ote nti al ?   
If Yes, Birt h C o ntr ol Met h o d Bre ast Fee di n g ?  
C o m me nts  
< S u bject I D >  
< Yes/ N o >  
< Birt h C o ntr ol M et h o d >   
< Yes/ N o >  
< C o m me nts >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
1 6. 2. 1. 4. 2. 2.  M ale Fertilit y/ C o ntr ac e pti o n  
S u bject N o.   
Se x u all y Acti ve ?   
A grees t o Us e C o n d o m ?  
Fe m ale p art ner a grees t o us e a 
hi g hl y eff ecti ve m et h o d of 
c o ntr ace pti o n ?  
A gree n ot t o d o n ate s per m 
f r o m first d os e a d mi nistr ati o n 
u ntil at le ast 9 0 d a ys after t he 
l ast st u d y dr u g a d mi nistr ati o n ? 
C o m me nts  
< S u bject I D >   
< Yes/ N o >   
< Yes/ N o >  
< Yes/ N o >  
< Yes/ N o >  
< C o m me nts >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 5  of 1 4 3  
1 6. 2. 1. 4. 3.  Dr u gs of A b use, Et h a n ol a n d C oti ni ne  
S u bject N o.   
D ate  a n d Ti m e   
A m p het a mi nes  Be nz o di a ze pi nes  C oc ai ne   
C a n n a bi n oi ds  O pi ates   
Et h a n ol   
C oti ni ne  
< S u bject I D >  < D D M M M Y Y Y Y 
h h: m m >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / 
Ne gati ve >  
< P ositi ve / Ne gati ve >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 6  of 1 4 3  
1 6. 2. 1. 4. 4.  Vir al S er ol o g y at Sc re e ni n g  
S u bject N o.  
Act u al D ate  a n d Ti m e   
Pr ot oc ol P h as e   
HI V -1 & HI V -2   
He p atitis B  
He p atitis C  
< S u bject I D >  
< D D M M M Y Y Y Y 
h h: m m >  
< Pr ot oc ol P has e >  
< Q ualitati ve Val ue >  
< Q ualitati ve Val ue >   
< Q ualitati ve Val ue >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
HI V –  H u ma n  I m m u n o deficie nc y Vir us  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 7  of 1 4 3  
1 6. 2. 1. 4. 5.  Pr e vi o us a n d C o nc o mit a nt Me dic ati o n  
S u bject N o.  
Dr u g N a m e  
[ A T C C o de] I n dic ati o n 
P h ar m ace utic al 
F or m  
D os e ( u nits)  Fre q ue nc y   
R o ute  
D ate a n d Ti m e  
St art  
E n d  
< S u bject I D >  < Ge neric na me 
[ X X X X X X X] > 
< T hera pe utic 
i n dicati o n > 
< P har mace utical 
F or m >  
< D os e ( u nits) >  < Fre q ue nc y >  < R o ute >   
< D D M M M Y Y Y Y >   
< D D M M M Y Y Y Y or 
O n g oi n g >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
A T C –  A nat o mical T hera pe utic C he mical 
N K  –  N ot  K n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 8  of 1 4 3  
1 6. 2. 1. 4. 6.  S A R S -C O V -2 Test  
S u bject N o.  
Act u al D ate  
Pr ot oc ol P h as e  
Res ult  
If U nsc he d ule d, Re as o n 
< S u bject I D >  
< D D M M M Y Y Y Y >   
< Pr ot oc ol P has e >  
< N ot detecta ble, Detecta ble, 
I nc o ncl usi ve > 
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or a ny of t he e v al u ati o ns.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 1 9  of 1 4 3  
1 6. 2. 1. 5.  C o m pli a nc e 
1 6. 2. 1. 5. 1.  I n vesti g ati o n al Pr o d u ct A d mi nistr ati o n 
S u bject N o.   
D ate  
Act u al  
Cl oc k Ti m e  
D os e ( u nits)  
I n vesti g ati o n al 
Pr o d uct 
F or m ul ati o n  
R o ute of 
A d mi nistr ati o n  
H a n ds a n d  
M o ut h C hec k ?  
1 5 0 m L of  
w ater t a ke n ? C o m me nts  
< S u bject I D >  
< D D M M M Y Y
Y Y/ N/ A >  
< h h m m/ N/ A >  < D os e ( u nits) >  < F or m ulati o n >  < R o ute >   
< Yes/ N o/ N/ A >  < Yes/ N o/ N/ A >  < C o m me nts >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
N/ A –  N ot A p plica ble  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 0  of 1 4 3  
1 6. 2. 1. 6.  I n di vi d u al P h ar m ac o ki netic D at a  
1 6. 2. 1. 6. 1.  Gi vi n ost at: I n di vi d u al P h ar m ac o ki n etic D at a  
1 6. 2. 1. 6. 1. 1.  Gi vi n ost at: I n di vi d u al Dr u g Pl as m a C o nc e ntr ati o n D at a 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 2. 1 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 2. 1 6 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 1. 2.  Gi vi n ost at: I n di vi d u al Pl as m a P h ar m ac o ki n etic P ar a mete rs  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 3 . 1. f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 3 . 16 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 1. 3.  Gi vi n ost at: I n di vi d u al Pl as m a P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 4. 1.  t o 1 4. 3. 2. 4. 2 .’ 
1 6. 2. 1. 6. 1. 4.  Gi vi n ost at: I n di vi d u al Uri ne E xc reti o n  D at a  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 2. 1 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 2. 1 6. f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 1. 5.  Gi vi n ost at: I n di vi d u al Uri ne P h ar m ac o ki n etic P ar a meters  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 3 . 1. f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 3 . 1 6. f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 1. 6.  Gi vi n ost at: I n di vi d u al Uri ne P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 5 . 1. t o 1 4. 3. 2. 5 .2. ’ 
1 6. 2. 1. 6. 1. 7.  Gi vi n ost at: D oc u me nt ati o n of St atistic al A n al ysis  
1 6. 2. 1. 6. 1. 7. 1.  Gi vi n ost at : Pl as m a N o n -C o m p art me nt al A n al ysis O ut p ut  
1 6. 2. 1. 6. 1. 7. 2.  Gi vi n ost at : Pl as m a N o n -C o m p art me nt al A n al ysis Pl ots  
1 6. 2. 1. 6. 1. 7. 3.  Gi vi n ost at : Uri n e N o n -C o m p art me nt al A n al ysis O ut p ut  
N ote: T he d oc u me nt ati o n of st atistic al a n alysis will be e xtr acte d P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 1  of 1 4 3  
1 6. 2. 1. 6. 2.  Gi vi n ost at  M et a b olite ( I T F 2 3 7 4): I n di vi d u al P h ar m ac o ki n etic D at a 
1 6. 2. 1. 6. 2. 1.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : I n di vi d u al Dr u g Pl as m a C o n ce ntr ati o n D at a 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 2. 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 2. 1 9 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 2. 2.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : I n di vi d u al Pl as m a P h ar m ac o ki n etic P ar a mete rs  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 3 .4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 3 . 19 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 2. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : I n di vi d u al Pl as m a P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 4. 3 . t o 1 4. 3. 2. 4. 4 .’ 
1 6. 2. 1. 6. 2. 4.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : I n di vi d u al Uri n e E xc r eti o n  D at a  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 2. 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 2. 1 9 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 2. 5.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : I n di vi d u al Uri n e P h ar m a c o ki netic P ar a meters 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 3 .4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 3 . 19 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 2. 6.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : In di vi d u al Uri n e P h ar m ac o ki netic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 5 .3 . t o 1 4. 3. 2. 5 .4 .’ 
1 6. 2. 1. 6. 2. 7.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : D oc u me nt ati o n of St atistic al A n al ysis  
1 6. 2. 1. 6. 2. 7. 1.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : Pl as m a N o n -C o m p art me nt al A n al ysis O ut p ut  
1 6. 2. 1. 6. 2. 7. 2.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : Pl as m a N o n -C o m p art me nt al A n al ysis Pl ots  
1 6. 2. 1. 6. 2. 7. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 4) : Uri ne N o n -C o m p art me nt al A n al ysis O ut p ut  
N ote: T he d oc u me nt ati o n of st atistic al a n alysis will be e xtr acte d P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 2  of 1 4 3  
1 6. 2. 1. 6. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5 ): I n di vi d u al P h ar m ac o ki n etic D at a 
1 6. 2. 1. 6. 3. 1.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : I n di vi d u al Dr u g Pl as m a C o n ce ntr ati o n D at a 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 2. 7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 2. 2 2 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 3. 2.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : I ndi vi d u al Pl as m a P h ar m ac o ki n etic P ar a mete rs  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 3 .7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 3 .2 2 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 3. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : I n di vi d u al Pl as m a P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 4. 5 . t o 1 4. 3. 2. 4. 6 .’ 
1 6. 2. 1. 6. 3. 4.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : I n di vi d u al Uri n e E xc r eti o n  D at a  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 2. 7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 2. 2 2 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 3. 5.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : I n di vi d u al Uri n e P h ar m a c o ki netic P ar a meters 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 3 .7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 3 .2 2 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 3. 6.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : In di vi d u al Uri n e P h ar m ac o ki netic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 5 .5 . t o 1 4. 3. 2. 5 .6 .’ 
1 6. 2. 1. 6. 3. 7.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : D oc u me nt ati o n of St atistic al A nal ysis  
1 6. 2. 1. 6. 3. 7. 1.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : Pl as m a N o n -C o m p art me nt al A n al ysis O ut p ut  
1 6. 2. 1. 6. 3. 7. 2.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : Pl as m a N o n -C o m p art me nt al A n al ysis Pl ots  
1 6. 2. 1. 6. 3. 7. 3.  Gi vi n ost at  M et a b olite (I T F 2 3 7 5) : Uri ne N o n -C o m p art me nt al A n al ysis O ut p ut  
N ote: T he d oc u me nt ati o n of st atistic al a n alysis will be e xtr acte d P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 3  of 1 4 3  
1 6. 2. 1. 6. 4.  Gi vi n ost at  M et a b olite ( I T F 2 4 4 0): I n di vi d u al P h ar m ac o ki n etic D at a 
1 6. 2. 1. 6. 4. 1.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : I n di vi d u al Dr u g Pl as m a C o n ce ntr ati o n D at a 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 2. 1 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 2. 2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 4. 2.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : I n di vi d u al Pl as m a P h ar m ac o ki n etic P ar a mete rs  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 3 .1 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 3 .2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 4. 3.  Gi vi n os t at M et a b olite (I T F 2 4 4 0) : I n di vi d u al Pl as m a P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 4. 9 . t o 1 4. 3. 2. 4. 1 0 .’ 
1 6. 2. 1. 6. 4. 4.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : I ndi vi d u al Uri n e E xc r eti o n  D at a  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 2. 1 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 2. 2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 4. 5.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : I n di vi d u al Uri n e P h ar m ac o ki netic P ar a meters  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 3 .1 4 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 3 .2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 4. 6.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : I n di vi d u al Uri n e P h ar m ac o ki netic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 5 .9 . t o 1 4. 3. 2. 5 .1 0 .’ 
1 6. 2. 1. 6. 4. 7.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : D oc u me nt ati o n of St atistic al A n al ysis 
1 6. 2. 1. 6. 4. 7. 1.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : Pl as m a N o n -C o m p art me nt al A n al ysis O ut p ut  
1 6. 2. 1. 6. 4. 7. 2.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : Pl as m a N o n -C o m p art me nt al A n al ysis Pl ots  
1 6. 2. 1. 6. 4. 7. 3.  Gi vi n ost at  M et a b olite (I T F 2 4 4 0) : Uri ne N o n -C o m p art me nt al A n al ysis O ut p ut  
N ote: T he d oc u me nt ati o n of st atistic al a n alysis will be e xtr acte d P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o:  2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 4  of 1 4 3  
1 6. 2. 1. 6. 5.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al P h ar m ac o ki n etic D at a 
1 6. 2. 1. 6. 5. 1.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al Dr u g Pl as m a C o n ce ntr ati o n D at a 
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her  i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 2. 7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 2. 2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 5. 2.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al Pl as m a P h ar m ac o ki n etic P ar a mete rs  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 1. 3 .7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 1. 3 .2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 5. 3.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al Pl as m a P h ar m ac o ki n etic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 4. 9 . t o 1 4. 3. 2. 4. 1 0 .’ 
1 6. 2. 1. 6. 5. 4.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al Uri n e E xc r eti o n  D at a  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 2. 7 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 2. 2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 5. 5.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): I n di vi d u al Uri n e P h ar m ac o ki netic P ar a meters  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 2. 3 .5 . f or si n gle-d ose d at a a n d 1 4. 3. 2. 2. 3 .2 8 . f or m ulti ple-d ose d at a ’ 
1 6. 2. 1. 6. 5. 6.  Gi vi n ost a t M et a b olite ( I T F 2 5 6 3): I n di vi d u al Uri n e P h ar m ac o ki netic Pr ofiles  
N ote: T he f oll o wi n g se nte nce s h o ul d be i nserte d i n t his se cti o n: ‘ N o f urt her i nf or m ati o n is pr ovi de d; refer t o 
secti o ns 1 4. 3. 2. 5 .9 . t o 1 4. 3. 2. 5 .1 0 .’ 
1 6. 2. 1. 6. 5. 7.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): D oc u me nt ati o n of St atistic al A n al ysis  
1 6. 2. 1. 6. 5. 7. 1.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): Pl as m a N o n -C o m p art me nt al A n al ysis O ut p ut  
1 6. 2. 1. 6. 5. 7. 2.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): Pl as m a N o n -C o m p art me nt al A n al ysis Pl ots  
1 6. 2. 1. 6. 5. 7. 3.  Gi vi n ost at  M et a b olite ( I T F 2 5 6 3): Uri ne N o n -C o m p art me nt al A n al ysis O ut p ut  
N ote: T he d oc u me nt ati o n of st atistic al a n alysis will be e xtr acte d P h oe nix ®  Wi n N o nli n
®  8. 2 or hi g her.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 5  of 1 4 3  
1 6. 2. 1. 7.  A d verse E ve nt Listi n gs ( E ac h S u bject)  
1 6. 2. 1. 7. 1.  Pr e -Tr e at me nt A d verse E ve nts 7 
1 6. 2. 1. 7. 2.  Tr e at me nt -E mer ge nt A d verse E ve nts 7 
7 T o be ge ner ate d as f oll o ws:  
S u bject N o.  D a y of 
D os e  
Tre at m e nt  Re p orte d 
Ter m  
Seri o us ?  
M a xi m al  
Se verit y  
C a us alit y  Acti o n 
T a ke n  
Me dic ati o n 
Re q uire d ?  O utc o m e  
A d vers e 
E ve nt St art 
D ate a n d 
Ti m e  
A d vers e 
E ve nt E n d  
D ate a n d 
Ti m e  
C o m me nts  
< S u bject 
I D > 
< Da y # >   
<I n vesti gati
o nal 
Pr o d uct >  
< A E 
Re p orte d 
T er m >  
< Yes/ N o >  < Mil d, 
M o derate or 
Se vere >  
< N ot 
Reas o na bl y 
P ossi ble or 
Reas o na bl y 
P ossi ble >  
< D os e 
I ncreas e d, 
D os e N ot 
C ha n ge d, 
D os e Rate 
Re d uce d, 
D os e 
Re d uce d, 
Dr u g 
I nterr u pte d, 
Dr u g 
Wit h dra w n, 
N ot 
A p plica ble 
or 
U n k n o w n >  
< Yes or 
N o >  
< Fatal, N ot 
Rec o vere d / 
N ot 
Res ol ve d, 
Rec o vere d / 
Res ol ve d, 
Rec o vere d / 
Res ol ve d 
wit h 
Se q uelae, 
Rec o veri n g 
/ Res ol vi n g 
or 
U n k n o w n >  
< D D M M M
Y Y Y Y 
h h: m m >  
< D D M M M
Y Y Y Y 
h h m m or 
O n g oi n g >  
< C o m me nts
>  
<I ns ert as ma n y r o ws as dee me d necessar y >  
N K  –  N ot  K n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “I nv esti g ati o n al Pr o d uct ” c ol u m n will o nly be ge ner ate d f or T a ble 1 6. 2. 3 .7. 2.  If a n A dverse Eve nt is rel ate d t o Me dic al Hist ory, t h at 
i nf or m ati o n will be re p orte d i n ‘ C o m me nts’. T he “ C o m me nts ” c ol u m n will o nly be ge ner ate d if t here are re p orte d  c o m me nts f or t he a dverse e ve nts . 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 6  of 1 4 3  
1 6. 2. 1. 7. 3.  S e ri o us A d ve rse E ve nts (I)  
S u bject N o.  
Re p orte d Ter m  
Re as o n f or Seri o us ness   
Det ails  
< S u bject I D >  
< A E Re p orte d T er m >   
< Reas o n >  
< S A E details >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 7  of 1 4 3  
1 6. 2. 1. 8.  Listi n gs of L a b or at or y Me as u re me nts b y S u bject 
1 6. 2. 1. 8. 1.  N or m al R a n ge of L a b or at or y V al ues  
N or m al R a n ge  
Fe m ale  
M ale  
C ate g or y   
A n al yte  
A ge  
U nits  
L L N   
U L N   
L L N   
U L N  Q u alit ati ve  
< Cate g or y >   
< La b orat or y A nal yte >  
< A ge i nter val >   
< U nits >   
< L o wer 
Li mit >  
< U p per 
Li mit >  
< L o wer 
Li mit >  
< U p per 
Li mit >  
< Q ualitati ve 
Val ues >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L L N  –  L o wer  Li mit  N or mal; U L N  –  U p per  Li mit  N or mal  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
. 
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 8  of 1 4 3  
1 6. 2. 1. 8. 2.  He m at ol o g y (I)  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
S u bject N o.  Act u al D ate  
a n d Ti m e  
Pr ot oc ol 
P h as e  
He m o gl o bi n  
( g/ d L) 
R B C  
( 1 0 ^ 1 2/ L) 
He m at ocrit  
( %) 
M C V  
(f L) 
M C H  
( p g) 
M C H C  
( g/ d L) 
R D W -C V  
( %) 
T ot al W B C  
( 1 0 ^ 9/ L) 
If 
U ns c he d ule
d, Re as o n  
< S u bject I D >  < D D M M M Y
Y Y Y 
h h m m >  
< Pr ot oc ol 
P has e >  
x x   
x x   
x x   
x x   
x x   
x x   
x x   
x x   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
R B C –  Re d Bl o o d Cell; M C V –  Mea n C or p usc ular V ol u me; M C H –  Mea n C or p usc ular He m o gl o bi n; M C H C –  Mea n C or p usc ular He m o gl o bi n C o nce ntrati o n; R D W -C V –  
C oefficie nt Variati o n of t he Re d Cell Distri b uti o n Wi dt h; W B C –  W hite Bl o o d Cell  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 2 9  of 1 4 3  
1 6. 2. 1. 8. 3.  He m at ol o g y (II)  
S u bject N o.  Act u al D ate  
a n d Ti m e  
Pr ot oc ol 
P h as e  
Ne utr o p hils  
( 1 0 ^ 9/ L) 
E osi n o p hils  
( 1 0 ^ 9/ L) 
B as o p hils  
( 1 0 ^ 9/ L) 
L y m p h oc ytes  
( 1 0 ^ 9/ L) 
M o n oc ytes  
( 1 0 ^ 9/ L) 
Pl atelets  
( 1 0 ^ 9/ L) 
Me a n Pl atelet 
V ol u m e  
(f L) 
If 
U ns c he d ule d, 
Re as o n  
< S u bject I D >  < D D M M M Y
Y Y Y h h: m m >  
< Pr ot oc ol 
P has e >  
x x   
x x   
x x   
x x   
x x   
x x   
x x   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 0  of 1 4 3  
1 6. 2. 1. 8. 4.  Bi oc h e mistr y (I)  
S u bject N o.  
Act u al D ate  
a n d Ti m e  
Pr ot oc ol P h as e  A S T  
(I U/ L) 
A L T  
(I U/ L) 
G G T  
(I U/ L) 
L D H  
(I U/ L) 
A L P  
(I U/ L) 
C K  
(I U/ L) 
If U nsc he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y
Y Y h h m m >  
< Pr ot oc ol 
P has e >  
x x  
x x x   
x x  
x x  
x x  
x x   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 1  of 1 4 3  
1 6. 2. 1. 8. 5.  Bi oc h e mistr y (II)  
S u bject N o.  
Act u al D ate  
a n d Ti m e  
Pr ot oc ol P h as e  Cre ati ni ne  
( m g/ d L) 
e G F R  
Ure a  
( m g/ d L) 
S o di u m  
( m m ol/ L) 
P ot assi u m  
( m m ol/ L) 
C alci u m 
( m g/ d L) 
If U nsc he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y
Y Y h h m m >  
< Pr ot oc ol 
P has e >  
x x  
x x x   
x x  
x x  
x x  
x x   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d R e as o n f or o ne of t he e v al u ate d p ar a meters.  
P P D


I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 2  of 1 4 3  
1 6. 2. 1. 8. 6.  Bi oc h e mistr y (III)  
S u bject N o.  
Act u al D ate  
a n d Ti m e  
Pr ot oc ol P h as e  M a g nesi u m 
( m g/ d L) 
Gl uc os e  
( m g/ d L) 
T ot al 
C h olester ol  
( m g/ d L) 
Tri gl yceri des  
( m g/ d L) 
Al b u mi n  
( g/ d L) 
T ot al Pr otei n  
( g/ d L) 
If 
U ns c he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y
Y Y h h m m >  
< Pr ot oc ol 
P has e >  
x x  
x x x   
x x  
x x  
x x  
x x  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 3  of 1 4 3  
1 6. 2. 1. 8. 7.  Bi oc h e mistr y (I V)  
S u bject N o.  
Act u al D ate  
a n d Ti m e  
Pr ot oc ol P h as e  Uric Aci d  
( m g/ d L) 
T ot al Bilir u bi n  
( m g/ d L) 
Direct 
Bilir u bi n  
( m g/ d L) 
I n direct 
Bilir u bi n  
( m g/ d L) 
T S H  
( mI U/ L) 
C hl ori de  
( m m ol/ L) 
If 
U ns c he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y
Y Y h h m m >  
< Pr ot oc ol 
P has e >  
x x  
x x x   
x x  
x x  
x x  
x x  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 4  of 1 4 3  
1 6. 2. 1. 8. 8.  Bi oc h e mistr y ( V)  
S u bject N o.  
Act u al D ate  
a n d Ti m e  
Pr ot oc ol P h as e  A m yl as e  
( g/ d L) 
L D L 
C h olester ol  
( m g/ d L) 
H D L 
C h olester ol  
( m g/ d L) 
F S H  
( m g/ d L) 
C -Re acti ve
Pr otei n
C yst ai n C  
If 
U ns c he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y
Y Y h h m m >  
< Pr ot oc ol 
P has e >  
x x  
x x x   
x x  
x x  
x x  
x x  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 5  of 1 4 3  
1 6. 2. 1. 8. 9.  C o a g ul ati o n  
S u bject N o.  
Act u al D ate  a n d 
Ti m e  
Pr ot oc ol P h as e  
Pr ot hr o m bi n R ate  
( %) 
Pr ot hr o m bi n Ti m e  
(s ec) 
I N R 
a P T T  
(s ec) 
If U nsc he d ule d, 
Re as o n  
< S u bject I D >   
< D D M M M Y Y Y Y 
h h: m m >  
< Pr ot oc ol P has e >  
x x  
x x. x
x. x x
x x. x
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
I N R –  I nter nati o nal N or malize d Rati o; a P T T –  Acti vate d Partial T hr o m b o plasti n Ti me  
L  –  L o w;  H  –  Hi g h;  C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 6  of 1 4 3  
1 6. 2. 1. 8. 1 0.  Uri n al ysis  
S u bject 
N o.  
Act u al 
D ate  a n d 
Ti m e  
Pr ot oc ol 
P h as e  
p H  
S pecific  
Gr a vit y  Pr otei n   
He m o gl o bi n  Gl uc os e   
Ket o nes   
Bilir u bi n   
Nitrites   
Ur o bili n o ge n  
If 
U ns c he d ule d, 
Re as o n  
< S u bject 
I D > 
< D D M M
M Y Y Y Y 
h h: m m >  
< Pr ot oc o
l P has e > x x. x 
x. x x x
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Q ualitati ve 
Val ue >  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h; N C R  –  N ot  Cli nicall y  Rele va nt;  C R  –  Cli nicall y  Rele va nt;  R U  - Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 7  of 1 4 3  
1 6. 2. 1. 8. 1 1.  Uri n e Micr osc o p y  
S u bject N o.  
Act u al D ate  a n d 
Ti m e  
Pr ot oc ol P h as e  
S q u a m o us 
E pit heli al Cells 
(/ u L) 
Er yt hr oc ytes 
(/ u L) 
Le u k oc ytes 
(/ u L) 
O bs er v ati o ns  
If U nsc he d ule d, 
Re as o n  
< S u bject I D >   
< D D M M M Y Y Y Y 
h h: m m >  
< Pr ot oc ol P has e >  < Q ualitati ve 
Val ue >  
x x  
x x  
< O bs er vati o ns >   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
L  –  L o w;  H  –  Hi g h; C R  –  Cli nicall y  Rele va nt;  N C R  –  N ot  Cli nicall y  Rele va nt;  R U  –  Rele va nce  U n k n o w n  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters. 
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 8  of 1 4 3  
1 6. 2. 1. 8. 1 2.  Pr e g n a nc y Test  
S u bject N o.  
Act u al D ate  a n d Ti m e  Pr ot oc ol P h as e   
M atri x  
Res ult  
If U nsc he d ule d, 
Re as o n  
< S u bject I D >  
< D D M M M Y Y Y Y 
h h: m m >  
< Pr ot oc ol P has e >   
< Ser u m or Uri ne >   
< P ositi ve or Ne gati ve >  
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y > 
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he of t he e v al u ati o ns.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 3 9  of 1 4 3  
1 6. 2. 1. 8. 1 3.  A d diti o n al ( N ot Pl a n ne d) L a b or at or y S afet y Tests  
S u bject N o.  
Act u al D ate a n d 
Ti m e  
Pr ot oc ol P h as e  
I n vesti g ati o n al 
Pr o d uct  
P ar a m eter   
Res ults  
Re as o n  
< S u bject I D >   
< D D M M M Y Y Y Y 
h h m m >  
< Pr ot oc ol P has e >   
<I n vesti gati o nal 
Pr o d uct >  
< Para meter >   
< Res ults >   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 4 0  of 1 4 3  
1 6. 2. 1. 9.  Vit al Si g ns  
S u bject N o.  Sc he d ule d 
Ti m e  
Act u al D ate 
a n d Ti m e  
Pr ot oc ol 
P h as e  
I n vesti g ati o n al 
Pr o d uct  
S B P 
( m m H g) 
D B P 
( m m H g) 
P ulse R ate  
( be ats/ mi n) 
B o d y 
Te m per at ure  
(º C) 
Res pir at or y 
R ate  
( be ats/ mi n) 
If 
U ns c he d ule d,  
Re as o n  
< S u bject I D >  < Sc he d ule d 
Ti me or 
U ns c he d ule d >  
< D D M M M Y
Y Y Y h h: m m >  
< Pr ot oc ol 
P has e >  
<I n vesti gati o na
l Pr o d uct >
x x   
x x   
x x   
x x   
x x   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y > 
S B P –  S yst olic Bl o o d Press ure; D B P –  Diast olic Bl o o d Press ure  
L –  L o w;  H –  Hi g h;  C R –  Cli nicall y  Rele va nt;  N C R –  N ot  Cli nicall y  Rele va nt  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or o ne of t he e v al u ate d p ar a meters.  
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 4 1  of 1 4 3  
1 6. 2. 1. 1 0.  1 2 -Le a d E C G  
S u bject N o.  
Sc he d ule d 
Ti m e  
Act u al D ate 
a n d Ti m e  
Pr ot oc ol P h as e  I n vesti g ati o n al 
Pr o d uct  
Q Tc F  
( ms ec) 
Res ult  
If A b n or m al, 
Re as o n  
If A b n or m al, 
Cli nic all y 
Si g nific a nt ?  
If 
U ns c he d ule d,  
Re as o n  
< S u bject I D >  
< Sc he d ule d 
Ti me or 
U ns c he d ule d >  
< D D M M M Y Y
Y Y h h: m m >  
< Pr ot oc ol 
P has e >  
<I n vesti gati o nal 
Pr o d uct >  
x x x   
< A b n or mal/ 
N or mal >  
< Reas o n f or 
bei n g 
c o nsi dere d 
a b n or mal >  
< Yes / N o >   
< Reas o n >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
N ote: T he “If U nsc he d ule d, Re as o n ” c ol u m n will o nly be ge ner ate d if t here is a n U nsc he d ule d Re as o n f or a ny of t he e v al u ati o ns. 
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I T F/ 2 3 5 7/ 55  
V er si o n: < V er si o n >  
D at e: < D D M M M Y Y Y Y >  
Cli ni c al St u d y R e p ort  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 4 2  of 1 4 3  
1 6. 2. 1. 1 1.  Uri n e S a m pli n g  
S u bject N o.  
D a y of D ose  
Pr ot oc ol Ti m e  
C ollecti o n Ti m e  
Uri ne V ol u m e  
St art  
E n d  
< S u bject I D >  
< Da y # >  
< Pr ot oc ol Ti me >   
< D D M M M Y Y Y Y 
h h: m m >  
< D D M M M Y Y Y Y 
h h: m m >  
< A b n or mal/ N or mal >  
<I ns ert as ma n y r o ws as dee me d necessar y >  
Pr o gr a m:  < S A S Pr o gra m >  
E xec uti o n  D ate/ Ti me:  < d d M M M y y y y H H: M M >  
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I T F/ 2 3 5 7/ 55  
V er si o n: 1. 0  
D at e: 2 4 M A R 2 0 2 2  
St ati sti c al A n al y si s Pl a n  
I T F 2 3 5 7/ Gi vi n o st at 1 0 m g/ m L or al s u s p e n si o n 
E u dr a C T N o: 2 0 2 1 - 00 5 7 5 6 - 11  
P a g e  1 4 3  of 1 4 3  
1 4. 
A N N E X E S
A n ne x 5: Data Bli n d Re vie w Pr oc ess Mi n ute –  Part 3  
A n ne x 6: List of S u bjects D ose d –  Part 3  
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I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 0 of  1 4 3
- 
P art  3:  ei g ht ( 8 ) s u bj e cts
E a c h s u bj e ct  will  p arti ci p at e i n  o n e st u d y  p art  o nl y.
P a rt  3
A s a m pl e si z e  of  8 s u bj e cts  will  b e  e nr oll e d.  T h e s a m pl e si z e  w as  d et er mi n e d  b y  pr a cti c al 
c o nsi d er ati o ns  a n d  n ot  b as e d  o n st atisti c al  p o w er  c al c ul ati o ns.
5. 4. 
R a n d o mi z ati o n
T his is  a fi x e d s e q u e n c e st u d y.  R a n d o mi z ati o n is  n ot  a p pli c a bl e.
5. 5. 
Bli n di n g
T h e st u d y  will  b e  c o n d u ct e d  as  o p e n l a b el.  Bli n di n g  pr o c e d ur es  ar e  n ot  a p pli c a bl e.
6. 
S T U D Y  A S S E S S M E N T S
F or  e a c h st u d y  p art,  a s u m m ar y  of  pr o c e d ur es  f or st u d y  ass ess m e nts ar e  pr es e nt e d i n  S e cti o n  2  of
t h e  C S P ( St u d y  Fl o w-C h art  a n d  St u d y  D esi g n  Di a gr a m) [1 ].
6. 1. 
S af et y  Ass ess m e nts
S u bj e cts’ s af et y  will  b e  m o nit or e d  d uri n g t h e st u d y.
S af et y  ass ess m e nts  will i n cl u d e  pr e -st u d y  m e di c al  hist or y,  p h ysi c al  e x a mi n ati o n,  vit al si g ns,  1 2 -l e a d 
E C G,  cli ni c al l a b or at or y t ests  a n d  a d v ers e  e v e nt ( A E ) m o nit ori n g.  A d diti o n al s af et y  m e as ur e m e nts 
m a y  b e  p erf or m e d  at t h e  dis cr eti o n  of t h e i n v esti g at or f o r r e as o ns r el at e d t o s u bj e ct s af et y.
M e di c ati o ns  will  b e  m e nti o n e d  a c c or di n g t o t h e  W orl d  H e alt h  Or g a ni z ati o n ( W H O)  A n at o mi c al 
T h er a p e uti c  C h e mi c al ( A T C)  cl assifi c ati o n s yst e m.
M e di c al  Hist o r y
M e di c al  hist or y  will  c o v er  all r el e v a nt  p ast  or  pr es e nt i nf o r m ati o n r el at e d t o s u bj e ct’s  h e alt h  at t h e 
ti m e  of i nf or m e d  c o ns e nt si g n at ur e.
M e di c al  hist or y  at s cr e e ni n g  will i n cl u d e  p ast  or  pr es e nt r el e v a nt  c ar di o v as c ul ar, r es pir at or y, r e n al, 
g e nit o uri n ar y,  g astr oi nt esti n al,  h e p ati c,  h e m at ol o gi c al, i m m u n ol o gi c al,  e n d o cri n e,  d er m at ol o gi c al, 
m us c ul os k el et al,  n e ur ol o gi c al,  ps y c hi atri c,  dr u g  a n d s ur gi c al  hist or y,  or  a n y  ot h er  dis e as es  or 
dis or d ers.
M e di c al  hist or y  will  b e r ef err e d i n  a c c or d a n c e  wit h t h e  M e di c al  Di cti o n ar y f or  R e g ul at or y  A cti viti es 
( M e d D R A),  v ersi o n  2 4.1 or  hi g h er.
A d v ers e  e v e nts r el at e d t o  m e di c al  hist or y  will  b e i d e ntifi e d.
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I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 1 of  1 4 3
P h ysi c al  E x a mi n ati o n
P h ysi c al  e x a mi n ati o n  at s cr e e ni n g  a n d  e n d -of -st u d y  will i n cl u d e:  g e n er al  a p p e ar a n c e; s ki n;  h e a d  a n d 
n e c k; t h or a x  a n d  a b d o m e n;  p ul m o n ar y  a us c ult ati o n;  c ar di a c  a us c ult ati o n;  a b d o m e n  p al p ati o n; li m bs; 
bri ef  n e ur ol o gi c al  e x a mi n ati o n.
W ei g ht,  H ei g ht  a n d  B o d y  M ass I n d e x 
T h e  b o d y  h ei g ht  a n d  w ei g ht  v al u es  as  w ell  as t h e  b o d y  m ass i n d e x ( B MI ) will  b e r e c or d e d i n t h e 
el e ctr o ni c  c as e r e p ort  f or m ( e C R F)  a n d will  b e  d et er mi n e d  at  S cr e e ni n g.  O nl y  b o d y  w ei g ht  will  b e 
d et er mi n e d  als o  at  a d missi o n  a n d  e n d -of -st u d y.
T h e s u bj e cts’  b o d y  w ei g ht  will  pr ef er a bl y  b e  m e as ur e d  usi n g t h e s a m e  w ei g hi n g s c al e f or  all 
s u bj e cts  a n d t hr o u g h o ut t h e st u d y.  T h e  w ei g hi n g s c al e s h o ul d  h a v e  a  pr e cisi o n  of  at l e ast  0. 5  k g.
Vit al  Si g ns
Vit al si g ns  will i n cl u d e:
- 
S yst oli c  bl o o d  pr ess ur e ( S B P).
- 
Di ast oli c  bl o o d  pr ess ur e ( D B P) .
- 
P uls e r at e ( P R).
- 
R es pir at or y r at e ( R R ).
- 
B o d y t e m p er at ur e.
1 2  L e a d  El e ct r o c a r di o g r a m
A  1 2 -l e a d  E CG  will  b e  p erf or m e d pr ef er a bl y  b ef or e t h e  bl o o d  c oll e cti o n . T h e  c orr e ct e d  Q T i nt er v al 
b y  Fri d eri ci a  (Q T c F ) will  b e  a n al y z e d.
L a b o r at o r y  S af et y  T ests
T h e f oll o wi n g l a b or at or y  p ar a m et ers  will  b e t est e d: 
- 
H e m at ol o g y:
- 
R e d  bl o o d  c ell ( R B C)  c o u nt.
- 
W hit e  bl o o d  c ell ( W B C)  c o u nt.
- 
W B C  diff er e nti al  c o u nt:
- 
N e utr o p hils.
- 
E osi n o p hils.
- 
B as o p hils.
- 
L y m p h o c yt es.
- 
M o n o c yt es.
- 
H e m o gl o bi n.
- 
M e a n  c or p us c ul ar  v ol u m e ( M C V).
- 
M e a n  c or p us c ul ar  h e m o gl o bi n ( M C H).
- 
M e a n  c or p us c ul ar  h e m o gl o bi n  c o n c e ntr ati o n ( M C H C).
- 
C o effi ci e nt  v ari ati o n  of t h e r e d  c ell  distri b uti o n  wi dt h ( R D W -C V).
- 
H e m at o crit .
- 
Pl at el et  c o u nt.
- 
M e a n  pl at el et  v ol u m e.
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D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 3 of  1 4 3
- 
S p e cifi c  gr a vit y.
- 
Pr ot ei n.
- 
H e m o gl o bi n.
- 
Gl u c os e.
- 
K et o n es.
- 
Bilir u bi n.
- 
Nitrit es.
- 
Ur o bili n o g e n.
- 
Mi cr os c o p y.
- 
Dr u gs -of -a b us e  uri n e t est:
- 
C a n n a bi n oi ds.
- 
O pi at es.
- 
C o c ai n e.
- 
A m p h et a mi n es.
- 
B e n z o di a z e pi n es.
- 
Et h a n ol  uri n e t est.
- 
C oti ni n e  uri n e t est.
- 
F olli cl e -sti m ul ati n g  h or m o n e ( F S H) t est.
- 
S e v er e  A c ut e  R es pir at or y  S y n dr o m e  C or o n a vir us  2 ( S A R S -C o V -2)  di a g n osti c t ests.
A d v e rs e  E v e nts
T h e  o c c urr e n c e  of  cli ni c al  A Es  will  b e  m o nit or e d t hr o u g h o ut t h e st u d y.
Cli ni c all y si g nifi c a nt  a b n or m aliti es i n l a b or at or y s af et y t ests,  vit al si g ns a n d  p h ysi c al  e x a mi n ati o n 
will  b e r e p ort e d  as  A Es.
Tr e at m e nt -e m er g e nt  A Es ( T E A Es)  ar e  d efi n e d  as  A Es  n ot  pr es e nt  pri or t o first  a d mi nistr ati o n  of 
i n v esti g ati o n al  pr o d u ct,  or  A Es  pr es e nt  b ef or e first  a d mi nistr ati o n  of i n v esti g ati o n al  pr o d u ct t h at 
w ors e n  aft er t h e s u bj e ct r e c ei v es t h e first  d os e  of i n v esti g ati o n al  pr o d u ct.  T E A Es t h at  o c c ur  aft er 
a d mi nistr ati o n  of i n v esti g ati o n al  pr o d u ct  d uri n g t h e  w as h o ut  of  a  gi v e n  p eri o d  will  b e  assi g n e d t o 
t h e tr e at m e nt  a d mi nist er e d i n t h at  p eri o d.
T h e f oll o wi n g i nf or m ati o n  will  b e  us e d f or t h e  d es cri pti o n  of t h e  A Es: 
- 
R e p ort e d  T er m.
- 
M e di c al  Di cti o n ar y f or  R e g ul at or y  A cti vit i es ( M e d D R A)  S yst e m  Or g a n  Cl ass ( S O C)
c o di n g.
- 
M e d D R A  Pr ef err e d  T er m ( P T)  c o di n g.
- 
St art  d at e  a n d ti m e.
- 
E n d  d at e  a n d ti m e.
- 
S eri o us n ess.
- 
S e v erit y:
- 
Mil d.
- 
M o d er at e.
- 
S e v er e.
- 
R el ati o ns hi p ( c a us alit y) f or e a c h tr e at m e nt  a d mi nistr at e d ,  p er  p art.
- 
R e as o n a bl y  P ossi bl e.
- 
N ot  R e as o n a bl y  P ossi bl e.
- 
U n k n o w n.
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V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 4 of  1 4 3
- 
A cti o n t a k e n:
- 
D os e I n cr e as e d.
- 
D os e  N ot  C h a n g e d.
- 
D os e  R at e  R e d u c e d.
- 
D os e  R e d u c e d.
- 
Dr u g I nt err u pt e d.
- 
Dr u g  Wit h dr a w n.
- 
N ot  A p pli c a bl e.
- 
U n k n o w n.
- 
C o n c o mit a nt  m e di c ati o n.
- 
O ut c o m e:
- 
F at al.
- 
N ot  R e c o v er e d /  N o t  R es ol v e d.
- 
R e c o v er e d /  R es ol v e d.
- 
R e c o v er e d /  R es ol v e d  wit h  S e q u el a e.
- 
R e c o v eri n g /  R es ol vi n g.
- 
U n k n o w n.
- 
M ost r e c e nt st u d y tr e at m e nt t a k e n.
- 
L ast  d osi n g  d at e.
P r e vi o us  a n d  C o n c o mit a nt  M e di c ati o ns
A  pr e vi o us  m e di c ati o n is  a n y  m e di c ati o n f or  w hi c h t h e  e n d  d at e is  pri or t o first  d osi n g.
A  c o n c o mit a nt  m e di c ati o n is  a n y  m e di c ati o n  o n g oi n g  or i niti at e d  aft er first  d osi n g. 
F or  all st u d y  p arts, t h e  us e  of  a n y  m e di c ati o ns i n cl u di n g  O v er -t h e-C o u nt er ( O T C)  pr o d u cts 
(i n cl u di n g  h er b al  m e di ci n es s u c h  as  St J o h n’s  W ort,  h o m e o p at hi c  pr e p ar ati o ns,  vit a mi ns,  a n d 
mi n er als) is f or bi d d e n fr o m  2 8  d a ys  or  wit hi n  5  h alf -li v es  of t h e  m e di ci n al  pr o d u ct,  w hi c h e v er is 
l o n g er,  pri or t o  a d missi o n  u p t o l ast s a m pl e f or  p h ar m a c o ki n eti cs  ass ess m e nt,  e x c e pt f or  m e di c ati o ns 
f or t h e tr e at m e nt  of  A Es.
A n y  m e di c ati o n ( pr e vi o us  or  c o n c o mit a nt) t a k e n  wit hi n t h e  p eri o d  of  m e di c ati o n r estri cti o n  m ust  b e 
r e c or d e d i n t h e  e C R F. If  c o n c o mit a nt  m e di c ati o n is  o n g oi n g  at t h e f oll o w -u p  visit,  n o  e n d  d at e  will 
b e  pr o vi d e d i n t h e  e C R F.
F or  e a c h st u d y  p art,  pr e vi o us  a n d  c o n c o mit a nt  m e di c ati o ns  us e d  b y st u d y  p arti ci p a nts  d uri n g t h e 
st u d y  a n d t h eir j u d g e d i m p a ct  o n t h e  p h ar m a c o ki n eti c  ass ess m e nt  will  b e list e d i n t h e  r es p e cti v e 
D at a  Bli n d  R e vi e w  M e eti n g/  Pr o c ess  Mi n ut e ( A n n e x  5 ). 
C o n c o mit a nt  m e di c ati o ns  will  b e  c o d e d  a c c or di n g t o t h e  W H O  A T C  cl assifi c ati o n s yst e m. 
6. 2. 
P h a r m a c o ki n eti c  Ass ess m e nts
Bl o o d  S a m pli n g f o r  P h a r m a c o ki n eti c  Ass ess m e nts
I n  e a c h st u d y  p art,  w hil e s u bj e ct is  c o nfi ne d  at t h e  cli ni c al r es e ar c h  u nit,  bl o o d s a m pl es  will  b e t a k e n 
pr ef er a bl y  vi a  a n i n d w elli n g  c a n n ul a  pl a c e d i n  a  v ei n  of  a n  u p p er li m b  of t h e s u bj e ct.  D uri n g 
a m b ul at or y  visits,  bl o o d s a m pl es  will  b e t a k e n  b y  dir e ct  v e ni p u n ct ur e.
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I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 5 of  1 4 3
T h e  a ct u al ti m e  of  all  p h ar m a c o ki n eti c  bl o o d  dr a ws  will  b e r e c or d e d  a n d r e p ort e d f or  all s u bj e cts. 
T h e  pr e -d os e  bl o o d s a m pl e  will  b e  c oll e ct e d  wit hi n  3 0  mi n ut es  b ef or e  d osi n g.  T h e  p ost -d os e  bl o o d 
s a m pl es  will  b e  c oll e ct e d  wit hi n  ± 3  mi n ut es fr o m t h e s c h e d ul e d s a m pli n g ti m e.  Gr e at er  d e vi ati o ns 
will  b e r e p ort e d  as  a  pr ot o c ol  d e vi ati o n  a n d its  c a us e  will  b e r e c or d e d.
I n  c as e  bl o o d s a m pli n g f or  p h ar m a c o ki n eti cs  a n d  ot h er  pr o c e d ur es  c oi n ci d e i n ti m e,  bl o o d  dr a ws 
will  h a v e  pri orit y  u nl ess  ot h er  pr o c e d ur es  ar e  n e c ess ar y f or  ass uri n g  s u bj e ct’s s af et y.
will  c arr y  o ut t h e  d et er mi n ati o n  of  pl as m a l e v els  of  gi vi n ost at  a n d  its 
m et a b olit es (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0  a n d I T F 2 5 6 3),  mi d a z ol a m,  1-h y dr o x y mi d a z ol a m  a n d t ot al 
a n d fr e e  d a bi g atr a n i n  a c c or d a n c e  wit h t h e  a p pli c a bl e  pri n ci pl es  of  G o o d  L a b or at or y  Pr a cti c es 
( G L P),  usi n g  a  pr e vi o usl y  v ali dat e d  li q ui d  c hr o m at o gr a p h y  wit h t a n d e m  m ass s p e ctr o m etr y ( L C-
M S/ M S)  a n al yti c al  m et h o d. 
T h e  pl a n n e d l o w er li mit  of  q u a ntifi c ati o n ( L L O Q)  a n d  u p p er li mit  of  q u a ntifi c ati o n ( U L O Q) f or:
- 
gi vi n ost at  ar e  1 a n d  1 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 3 7 4  ar e  1 a n d  1 0 0  n g / m L.
- 
gi vi n ost at  m et a b olit e I T F 2 3 7 5  ar e  1 a n d  1 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 4 4 0  ar e  1 0 a n d  5 0 0 n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 5 6 3 ar e  2 a n d  1 2 5 n g/ m L .
- 
mi d a z ol a m  ar e  1 0 0 a n d  1 0 0 0 0 0  p g/ m L .
- 
1 -h y dr o x y mi d a z ol a m  ar e  1 0 0 a n d  5 0 0 0 0  p g/ m L .
- 
t ot al  d a bi g atr a n  ar e 1 a n d  4 0 0  n g/ m L .
- 
fr e e  d a bi g atr a n  ar e 1 a n d  4 0 0  n g/ m L .
L L O Q r e pr es e nts  a  v al u e l o w er t h a n  or  e q u al t o  1/ 2 0  of  esti m at e d  C m a x v al u e.  A n y  a dj ust m e nt t o t his 
ra n g e  will  b e  d o c u m e nt e d i n t h e st u d y s p e cifi c  Bi o a n al yti c al  R e p ort,  w hi c h  will s u p ers e d e t h e 
i n di c at e d r a n g e.
6. 2. 1. 1. 
P a rt  3
A t ot al  of  f ort y-ei g ht ( 4 8 ) bl o o d s a m pl es  will  b e  c oll e ct e d  as f oll o ws:
- 
T w e nt y -t w o ( 2 2) bl o o d s a m pl es  of  6  m L  e a c h  will  b e  c oll e ct e d i n s o di u m  h e p ari n t u b es  at
pr e -d os e  a n d  at  0. 5,  1,  1. 5,  2,  2. 5,  3,  3. 5,  4,  5,  6,  8,  1 0,  1 2,  1 5,  2 4,  3 6,  4 8,  6 0,  7 2,  8 4  a n d  9 6
h o urs  aft er t h e  a d mi nistr ati o n  of  gi vi n ost at,  o n  D a ys  1  a n d  1 3, f or t h e  d et er mi n ati o n  of
gi vi n ost at  a n d its  m et a b olit es (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0  a n d I T F 2 5 6 3)  pl as m a
c o n c e ntr ati o ns.
- 
F o ur ( 4)  bl o o d s a m pl es  of  6  m L  e a c h  will  b e  c oll e ct e d i n s o di u m  h e p ari n t u b es  b ef or e t h e
m or ni n g  d os e  of  gi vi n ost at  o n  D a ys  9,  1 0,  1 1  a n d  1 2, f or t h e  d et er m i n ati o n  of  pr e-d os e
( Ctr o u g h)  pl as m a  c o n c e ntr ati o n  of  gi vi n ost at  a n d  m et a b olit es.
U ri n e  S a m pli n g f o r  P h a r m a c o ki n eti c  Ass ess m e nts
6. 2. 2. 1. 
P a rt  3
Uri n e  will  b e  c oll e ct e d  o n  D a y  -1 ( b as eli n e)  a n d i n t h e f oll o wi n g i nt er v als,  o n  D a ys  1  a n d  1 3, f or t h e 
d et er mi n ati o n  of t h e  a m o u nts  of  gi vi n ost at  a n d its  m et a b olit es (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0  a n d 
I T F 2 5 6 3)  e x cr et e d i n  uri n e:  0– 1 2,  1 2 – 2 4,  2 4 – 3 6,  3 6 – 4 8,  4 8 – 7 2  a n d  7 2 – 9 6  p ost -d os e.
P P D
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D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 6 of  1 4 3
T h e  d at e  a n d  a ct u al ti m e  of  uri n e  c oll e cti o n st art  a n d  c o m pl eti o n  will  b e r e c or d e d  a n d r e p ort e d f or 
all s u bj e cts.
will  c arr y  o ut t h e  d et er mi n ati o n  of  uri n e l e v els  of  gi vi n ost at  a n d its 
m et a b olit es (I T F 2 3 7 4,  I T F 2 3 7 5, I T F 2 4 4 0  a n d I T F 2 5 6 3) i n  a c c or d a n c e  wit h t h e  a p pli c a bl e  pri n ci pl es 
of  G L P  usi n g  a  pr e vi o usl y  v ali d at e d  li q ui d  c hr o m at o gr a p h y  wit h t a n d e m  m ass s p e ctr o m etr y ( L C-
M S/ M S)  a n al yti c al  m et h o d.
T h e  pl a n n e d l o w er li mit  of  q u a ntifi c ati o n ( L L O Q)  a n d  u p p er li mit  of  q u a ntifi c ati o n ( U L O Q) f or:
- 
gi vi n ost at  ar e  1 0 a n d  2 5 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 3 7 4  ar e  5 a n d  2 5 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 3 7 5  ar e  4 a n d  8 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 4 4 0  ar e  1 5 0 a n d  2 5 0 0 0  n g/ m L .
- 
gi vi n ost at  m et a b olit e I T F 2 5 6 3 ar e  1 0 a n d  5 0 0 0  n g/ m L .
Pl as m a  P h a r m a c o ki n eti c  P a r a m et e rs
T h e f oll o wi n g  p h ar m a c o ki n eti c  p ar a m et ers  will  b e  d eri v e d  b y st a n d ar d  n o n -c o m p art m e nt al  a n al ysis 
( N C A)  m et h o ds fr o m t h e si n gl e-d os e  pl as m a  c o n c e ntr ati o n  v ers us ti m e  pr ofil es, f or:
- 
P art  3 ( D a y  1):
- 
gi vi n ost at.
- 
gi vi n ost at  m et a b olit es (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0  a n d I T F 2 5 6 3).
P ar a m et er 
D es cri pti o n
C m a x
M a xi m u m  o bs er v e d  c o n c e ntr ati o n,  dir e ctl y  o bt ai n e d fr o m t h e  o bs er v e d 
c o n c e ntr ati o n  v ers us ti m e  pr ofil e.
T m a x
Ti m e  of  o c c urr e n c e  of  m a xi m u m  o bs er v e d  c o n c e ntr ati o n.
A U C 0 -t 1
Ar e a  u n d er t h e  c o n c e ntr ati o n  v ers us ti m e  c ur v e ( A U C) fr o m ti m e  of  d osi n g 
(t = 0 h) t o t h e ti m e  of t h e l ast  m e as ur a bl e  c o n c e ntr ati o n (tl ast),  c al c ul at e d  b y 
t h e li n e ar-u p/l o g -d o w n tr a p e z oi d al  m et h o d.
A U C 0 -∞
T ot al  A U C  e xtr a p ol at e d t o i nfi nit y,  c al c ul at e d  as  A U C 0 − t +
C l a s t
λ z ,  w h er e  Cl ast
is t h e l ast  m e as ur a bl e  c o n c e ntr ati o n  a n d  λz is t h e  a p p ar e nt t er mi n al 
eli mi n ati o n r at e  c o nst a nt.
% A U C
e xtr a p
P er c e nt a g e  of  A U C 0 -∞d u e t o  e xtr a p ol ati o n fr o m t h e ti m e  of t h e l ast 
m e as ur a bl e  c o n c e ntr ati o n (t l ast) t o i nfi nit y, i. e., r esi d u al  ar e a,  c al c ul at e d  as 
1 0 0 ∙
A U C 0 − ∞− A U C 0 − t
A U C 0 − ∞
.
λ z
A p p ar e nt first  or d er  eli mi n ati o n r at e  c o nst a nt  ass o ci at e d  wit h t h e t er mi n al 
(l o g-li n e ar)  p orti o n  of t h e  c o n c e ntr ati o n v ers us ti m e  c ur v e.  T h e  p ar a m et er is 
esti m at e d  b y li n e ar l e ast s q u ar e r e gr essi o n  a n al ysis  usi n g t h e l ast t hr e e ( or 
m or e)  n o n -z er o  c o n c e ntr ati o ns. 
t½
A p p ar e nt t er mi n al  eli mi n ati o n  h alf -lif e,  c al c ul at e d  as 
𝑙 𝑛( 2 )
λ z .
1 I n  P art 3 , f or  gi vi n ost at a n d its  m et a b olit es t h e l ast s a m pli n g ti m e  c orr es p o n ds t o 9 6 h o urs.
P P D
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V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n 
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11
P a g e 1 8 of  1 4 3
I n  esti m ati n g t h e  p h ar m a c o ki n eti c  p ar a m et ers,  c o n c e ntr ati o ns  b el o w t h e  L L O Q  b ef or e T m a x will  b e 
s et t o  z er o.  Aft er  T m a x ,  c o n c e ntr ati o ns  b el o w t h e  L L O Q  will  b e  c o nsi d er e d  as  missi n g.  H o w e v er, i n 
c as e  of t w o  or  m or e  c o ns e c uti v e  c o n c e ntr ati o ns  b el o w t h e  L L O Q, t h e first v al u e  will  b e r e pl a c e d  b y 
½  of t h e  L L O Q  v al u e  a n d t h e  n e xt  v al u es  will  b e  c o nsi d er e d  as  missi n g.
A d diti o n al  p h ar m a c o ki n eti c  p ar a m et ers  m a y  b e  c al c ul at e d f or t h e  pl as m a  c o n c e ntr ati o n v ers us ti m e 
pr ofil es, if  c o nsi d er e d  a p pr o pri at e  a n d j ustifi e d  at t h e ti m e  of t h e  p h ar m a c o ki n eti c  a n al ysis.
U ri n a r y P h a r m a c o ki n eti c  P a r a m et e rs
T h e f oll o wi n g  p h ar m a c o ki n eti c  p ar a m et ers  will  b e  d eri v e d  b y st a n d ar d  N C A  m et h o ds fr o m t h e  uri n e
e x cr eti o n pr ofil es, f or t h e first  d os e ( D a y  1, si n gl e-d os e )  a n d t h e l ast  d os e ( D a y  1 3, m ulti pl e -d os e ):
- 
P art  3:
- 
gi vi n ost at.
- 
gi vi n ost at  m et a b olit es (I T F 2 3 7 4, I T F 2 3 7 5, I T F 2 4 4 0  a n d I T F 2 5 6 3).
P ar a m et er 
D es cri pti o n
R m a x
M a xi m u m  o bs er v e d  uri n ar y  e x cr eti o n r at e .
t um a x
Ti m e  of  o c c urr e n c e  of  m a xi m u m  uri n ar y  e x cr eti o n r at e .
A mt C U M
C u m ul ati v e  a m o u nt  of  dr u g  e x cr et e d i n  uri n e ,  c al c ul at e d  as 
∑( 𝑙 𝑛 𝐷 𝑜 𝑠 𝑒𝐷 𝑜 𝑠 𝑒𝑖 𝑜 𝑛 ∙ 𝑉 𝑜𝑙 𝑢 𝑚 𝑒 )
A U R C 0 -t
Ar e a  u n d er t h e  uri n e  e x cr eti o n  r at e c ur v e fr o m ti m e  z er o t o l ast  m e as ur a bl e 
o bs er v e d  e x cr eti o n r at e.
R E C %
P er c e nt a g e  of  dr u g r e c o v er e d i n  uri n e , c al c ul at e d  f or  gi vi n ost at as  1 0 0 ∙
𝐴 𝑚 𝑡𝐶 𝑈 𝑀
D o s e
,  a n d f or gi vi n ost at  m et a b olit es  as  1 0 0 ∙
𝐴 𝑀 𝑇𝐶 𝑈 𝑀 ,𝑀 𝑒 𝑡 𝑎 𝑏 𝑜𝑙𝑖 𝑒
𝑀 𝑊𝑀 𝑒 𝑡 𝑎 𝑏 𝑜𝑙𝑖 𝑡 𝑒
⁄
𝐷 𝑜 𝑠 𝑒𝐺𝑖 𝑣𝑖 𝑛 𝑜 𝑠 𝑡 𝑎 𝑡
𝑀 𝑊𝐺𝑖 𝑣𝑖 𝑛 𝑜 𝑠 𝑡 𝑎 𝑡
⁄
, w h er e  M W r e pr es e nts t h e  m ol e c ul ar  w ei g ht 
of t h e  a n al yt e.
N ot e:  F or  gi vi n ost at,  M W is  4 2 1. 4 9  g/ m ol; f or I T F 2 3 7 4 ,  M W is  4 0 5. 4 9 
g/ m ol; f or I T F 2 3 7 5,  M W is  4 0 6. 4 7  g/ m ol; f or I T F 2 4 4 0,  M W is  2 5 7. 3 3 
g/ m ol;  a n d f or I T F 2 5 6 3,  M W is  1 7 8. 1 9  g/ m ol .
C L R / F
A p p ar e nt  r e n al  cl e ar a n c e  aff e ct e d  b y  F,  c al c ul at e d  as 
𝐷 𝑜 𝑠 𝑒
A U R C 0 − t.
7. 
S T U D Y  E N D P OI N T S
7. 1. 
P ri m a r y
1. 
Gi vi n ost at  a n d its  m et a b olit es  pl as m a  a n d  uri n e  c o n c e ntr ati o ns  a n d t h er e of  d eri v e d
p h ar m a c o ki n eti c  p ar a m et ers f oll o wi n g si n gl e  a n d  m ulti pl e  or al  d os es  of  gi vi n ost at ( P art  3).
7. 2. 
S e c o n d a r y
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D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 1 9 of  1 4 3
1. 
I n ci d e n c e  a n d s e v erit y  of  A Es;  c h a n g es i n  vit al si g ns,  p h ysi c al  e x a mi n ati o n,  E C G  a n d
cli ni c al l a b or at or y t ests f oll o wi n g  a d mi nistr ati o n  of si n gl e - a n d  m ulti pl e -d os es  of  gi vi n ost at
( P art  3).
8. 
A N A L Y SI S  P O P U L A TI O N S
T h e  a n al ysis  p o p ul ati o ns  ar e  d efi n e d i n  a c c or d a n c e  wit h t h e  C S P  [ 1].
F or  e a c h st u d y  p art, t h e s u bj e cts t o  b e i n cl u d e d i n  e a c h  a n al ysis  p o p ul ati o n  will  b e r e p ort e d i n t h e
r es p e cti v e D at a  Bli n d  R e vi e w  Pr o c ess Mi n ut e ( A n n e x  5 ).
F or  e a c h st u d y  p art,  e x pl a n ati o n  of t h e r e as o ns f or  e x cl usi o n  of s u bj e cts fr o m  a n y  a n al ysis
p o p ul ati o n  will  b e  pr o vi d e d i n t h e  r es p e cti v e D at a  Bli n d  R e vi e w  Pr o c ess Mi n ut e ( A n n e x  5 )  a n d i n
t h e  C S R.
T h e list  of s u bj e cts  w h o  c o m pl et e  e a c h st u d y  p art will  b e  pr es e nt e d i n  A n n e x  6 .
8. 1. 
P a rt  3
P a rt  3  S af et y  A n al ysis  P o p ul ati o n
All s u bj e cts  w h o r e c ei v e  at l e ast  o n e  d os e  of  t h e I M P i n  P art 3 of t h e st u d y  will  c o nstit ut e t h e  P art  3
S af et y  A n al ysis  P o p ul ati o n.
P art  3 s af et y  d at a  a n al ysis  will  b e  p erf o r m e d f or  all s u bj e cts i n t h e  P art 3 S af et y  A n al ysis 
P o p ul ati o n.
P a rt  3  P h a r m a c o ki n eti c  A n al ysis  P o p ul ati o n
8. 1. 2. 1. 
P a rt  3  Si n gl e -D os e  P h a r m a c o ki n eti c  A n al ysis  P o p ul ati o n
P art  3  Si n gl e -D os e  P h ar m a c o ki n eti c  A n al ysis  P o p ul ati o n  will i n cl u d e  all s u bj e cts  e nr oll e d i n  P art  3 
of t h e st u d y,  w h o  ar e  e x p e ct e d t o  pr o vi d e  e v al u a bl e  p h ar m a c o ki n eti c  d at a f or  t h e gi vi n ost at  si n gle -
d os e  a d mi nistr ati o n ( D a y  1) ,  wit h o ut  d e vi ati o ns  aff e cti n g  p h ar m a c o ki n eti c i nt er pr et ati o n.
T h e f oll o wi n g r e as o ns j ustif y t h e  e x cl usi o n  of t h e  p h ar m a c o ki n eti c  d at a  of  a s u bj e ct fr o m t h e  P art  3 
si n gl e -d os e  p h ar m a c o ki n eti c a n al ysis  p o p ul ati o n :
- 
Pr ot o c ol  vi ol ati o n  c o nsi d er e d t o  h a v e  a  p ot e nti all y r el e v a nt  eff e ct  o n t h e  p h ar m a c o ki n eti c
r es ults  of t h e st u d y.
N O T E:  T h e se pr ot o c ol  vi ol ati o ns will  b e  r e p ort e d i n t h e  D at a  Bli n d  R e vi e w  Pr o c ess Mi n ut e 
(A n n e x  5 ), a n d t h eir  i m p a ct will  b e  ass ess e d  at t h e ti m e  of  p h ar m a c o ki n eti c  a n al ysis.
- 
S u bj e ct  e x p eri e n c e d  v o miti n g  or  di arr h e a.
N O T E:  S u bj e cts t h at  e x p eri e n c e d  v o miti n g  or  di arr h o e a  d uri n g t h is st u d y  p art w ill  b e 
r e p ort e d i n t h e  D at a  Bli n d  R e vi e w  Pr o c ess Mi n ut e  (A n n e x  5 ), a n d t h eir  e x cl usi o n  will  b e 
ass ess e d  at t h e ti m e  of  p h ar m a c o ki n eti c  a n al ysis.
P P D


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V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n 
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11
P a g e 2 6 of  1 4 3
a n d/ or  S A S ® .
I n-t e xt  T a bl es  a n d  Fi g ur es  will  pr ef er a bl y  b e  pr e p ar e d i n  p ortr ait f or m at.  Listi n gs  will  pr ef er a bl y  b e 
pr e p ar e d i n l a n ds c a p e f or m at .
T h e  C S R  will  b e  writt e n  a c c or di n g t o 
S O Ps  a n d t e m pl at es f or r e p orti n g 
bi o a v ail a bilit y/ bi o e q ui v al e n c e tri als. 
1 1. 2. 
Pl a n n e d  T a bl es,  Fi g u r es,  a n d  S u bj e ct  D at a  Listi n gs
T h e  pl a n n e d  T a bl es,  F i g ur es,  a n d In di vi d u al  D at a  L isti n gs f or t h e  C S R  ar e list e d  b el o w. 
I n -t e xt  T a bl es  a n d  Fi g u r es
F or  C S R  S y n o psis: 
T h e  f oll o wi n g T a bl es  will  b e  pr o d u c e d f or  dir e ct i ns erti o n i n t h e  S y n o psis  of t h e  C S R:
Titl e
P A R T  3
Gi vi n ost at  a n d Its  M ai n  M et a b olit es (I T F 2 3 7 4  a n d I T F 2 3 7 5,):  S u m m ar y  St atisti cs  of t h e  Pl as m a 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1)
Gi vi n ost at  M et a b olit es (I T F 2 4 4 0  a n d I T F 2 5 6 3):  S u m m ar y  St atisti cs  of t h e  Pl as m a 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1)
Gi vi n ost at  a n d Its  M ai n  M et a b olit es (I T F 2 3 7 4  a n d I T F 2 3 7 5,):  S u m m ar y  St atisti cs  of t h e  Pl as m a 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  M ulti pl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1 3)
Gi vi n ost at  M et a b olit es (I T F 2 4 4 0  a n d I T F 2 5 6 3):  S u m m ar y  St atisti cs  of t h e  Pl as m a 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  M ulti pl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1 3)
Gi vi n ost at  a n d Its  M ai n  M et a b olit es (I T F 2 3 7 4  a n d I T F 2 3 7 5):  S u m m ar y  St atisti cs  of t h e  Uri n ar y 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1)
Gi vi n ost at  M et a b olit es (I T F 2 4 4 0  a n d I T F 2 5 6 3):  S u m m ar y  St atisti cs  of t h e  Uri n ar y 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1)
Gi vi n ost at  a n d Its  M ai n  M et a b olit es (I T F 2 3 7 4  a n d I T F 2 3 7 5):  S u m m ar y  St atisti cs  of t h e  Uri n ar y 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  M ulti pl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1 3)
Gi vi n ost at  M et a b olit es (I T F 2 4 4 0  a n d I T F 2 5 6 3):  S u m m ar y  St atisti cs  of t h e  Uri n ar y 
P h ar m a c o ki n eti c  P ar a m et ers  F oll o wi n g  M ulti pl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1 3)
T h e f oll o wi n g Fi g ur es  will  b e  pr o d u c e d f or  dir e ct i ns erti o n i n t h e  S y n o psis  of t h e  C S R:
L e g e n d
P A R T  3
Gi vi n ost at:  G e o m etri c  M e a n ( 9 5 %  CI)  Pl as m a  C o n c e ntr ati o n  V ers us Ti m e  Pr ofil e  F oll o wi n g 
Si n gl e -D os e ( D a y  1)  a n d  M ulti pl e -D os e ( D a y  1 3)  A d mi nistr ati o n  of  Gi vi n ost at.  A  – Li n e ar 
P P D
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D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 3 0 of  1 4 3
I n -t e xt  Fi g u r es 
L e g e n d
A m o u nt  Uri n ar y  E x cr eti o n  V ers us Ti m e  Pr ofil e  F oll o wi n g  Si n gl e -D os e ( D a y 
1) a n d  M ulti pl e -D os e ( D a y  1 3)  A d mi nistr ati o n  of  Gi vi n ost at  – Li n e ar  S c al e
Fi g ur e  3.J. 1.  
Gi vi n ost at  M et a b olit e (I T F 2 5 6 3):  G e o m etri c  M e a n ( 9 5 %  CI)  of  Uri n ar y 
E x cr eti o n  V ers us Ti m e  Pr ofil e  F oll o wi n g  Si n gl e -D os e ( D a y  1)  a n d  M ulti pl e -
D os e ( D a y  1 3)  A d mi nistr ati o n  of  Gi vi n ost at  – Li n e ar  S c al e
Fi g ur e  3.J. 2.  
Gi vi n ost at  M et a b olit e (I T F 2 5 6 3):  G e o m etri c  M e a n ( 9 5 %  CI)  of  C u m ul ati v e 
A m o u nt  Uri n ar y  E x cr eti o n  V ers us Ti m e  Pr ofil e  F oll o wi n g  Si n gl e -D os e ( D a y 
1) a n d  M ulti pl e -D os e ( D a y  1 3)  A d mi nistr ati o n  of  Gi vi n ost at  – Li n e ar  S c al e
T a bl es,  Fi g u r es  a n d  G r a p hs  R ef e r r e d t o  B ut  N ot I n cl u d e d i n t h e  T e xt ( S e cti o n  1 4  of  C S R)
At l e ast t h e f oll o wi n g  T a bl es  a n d  Fi g ur es s h o ul d  b e  pr o d u c e d f or  S e cti o n  1 4  of t h e  C S R.
If  n e c ess ar y,  a d diti o n al  T a bl es  a n d  Fi g ur es s h o ul d  b e  pr e p ar e d.
T h e f oll o wi n g  T a bl es  a n d  Fi g ur es  will  b e  c o m pil e d i n  a  d o c u m e nt, t o  b e  c o nsi d er e d  as  S e cti o n  1 4 
( T a bl es,  Fi g ur es  a n d  Gr a p h  R ef err e d  T o  B ut  N ot I n cl u d e d i n t h e  T e xt)  of t h e  C S R .
E n d -of -T e xt 
T a bl es
Titl e
1 4. 3.  P A R T  3
1 4. 3. 1.  D E M O G R A P HI C  D A T A  – P A R T  3
1 4. 3. 1. 1.  
D e m o g r a p hi c  D at a  – P a rt  3  S af et y  A n al ysis  P o p ul ati o n
1 4. 3. 1. 2.  
D e m o g r a p hi c  D at a  – P a rt  3  Si n gl e -D os e  P h a r m a c o ki n eti c  A n al ysis 
P o p ul ati o n
1 4. 3. 1. 3 .  
D e m o g r a p hi c  D at a  – P a rt  3  M ulti pl e -D os e  P h a r m a c o ki n eti c  A n al ysis 
P o p ul ati o n
1 4. 3. 1. 4 .  
S u bj e cts  P r e m at u r el y  Dis c o nti n u e d  Aft e r  Fi rst  D osi n g
1 4. 3. 2.  P H A R M A C O KI N E TI C  D A T A  – P A R T  3
1 4. 3. 2. 1.  
Pl as m a  P h a r m a c o ki n eti c  D at a
1 4. 3. 2. 1. 1.  
D e vi ati o ns fr o m  Bl o o d  S a m pli n g  S c h e d ul e
1 4. 3. 2. 1. 1. 1.  
D e vi ati o ns fr o m  Bl o o d  S a m pli n g  S c h e d ul e
1 4. 3. 2. 1. 1. 2.  
Missi n g  Bl o o d  S a m pl es
1 4. 3. 2. 1. 1. 3.  
Ot h er I m p ort a nt  Pr ot o c ol  D e vi ati o ns
1 4. 3. 2. 1. 2.  
Pl as m a  C o n c e ntr ati o ns
1 4. 3. 2. 1. 2. 1.  
Gi vi n ost at: I n di vi d u al  D at a  a n d  D es cri pti v e  St atisti cs  of  Pl as m a 
C o n c e ntr ati o ns  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1)
1 4. 3. 2. 1. 2. 2. 
Gi vi n ost at: I n di vi d u al  D at a  a n d  D es cri pti v e  St atisti cs  of  Pl as m a 
C o n c e ntr ati o ns  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1) 
– M al e  S u bj e cts
1 4. 3. 2. 1. 2. 3.  
Gi vi n ost at: I n di vi d u al  D at a  a n d  D es cri pti v e  St atisti cs  of  Pl as m a 
C o n c e ntr ati o ns  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of  Gi vi n ost at ( D a y  1) 
– F e m al e  S u bj e cts
1 4. 3. 2. 1. 2. 4.  
Gi vi n ost at  M et a b olit e (I T F 2 3 7 4): I n di vi d u al  D at a  a n d  D es cri pti v e  St atisti cs 
of  Pl as m a  C o n c e ntr ati o ns  F oll o wi n g  Si n gl e -D os e  A d mi nistr ati o n  of 
Gi vi n os t at ( D a y  1)
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I T F/ 2 3 5 7/ 55
V er si o n:  1. 0
D at e:  2 4 M A R 2 0 2 2
St ati sti c al  A n al y si s  Pl a n
I T F 2 3 5 7/ Gi vi n o st at  1 0  m g/ m L  or al  s u s p e n si o n
E u dr a C T  N o:  2 0 2 1 - 00 5 7 5 6 - 11 
P a g e 4 6 of  1 4 3
List  of  S u bj e ct  D at a  Listi n gs ( S e cti o n  1 6. 2  of  C S R)
T h e f oll o wi n g  D at a  Listi n gs  will  b e  pr o d u c e d f or  S e cti o n  1 6. 2.  S u bj e ct  D at a  Listi n gs  of t h e  C S R.
If  n e c ess ar y,  a d diti o n al  D at a  Listi n gs s h o ul d  b e  pr e p ar e d.
Listi n g  N o. 
Titl e
1 6. 2.  S U BJ E C T S  D A T A  LI S TI N G
1 6. 2. 3 . P art  3
1 6. 2. 3. 1. 
S u bj e ct  Dis p ositi o n
1 6. 2. 3. 1. 1.  
S u bj e ct  Dis p ositi o n
1 6. 2. 3. 2. 
P r ot o c ol  D e vi ati o ns
1 6. 2. 3. 2. 1.  
Bl o o d  S a m pli n g  Ti m es  D e vi ati o ns
1 6. 2. 3. 2. 2.  
Ot h er  Pr ot o c ol  D e vi ati o ns
1 6. 2. 3. 3. 
E x cl u d e d  D at a f r o m t h e  P h a r m a c o ki n eti c  A n al ysis
1 6. 2. 3. 3. 1.  
Pl as m a  C o n c e ntr ati o ns
1 6. 2. 3. 3. 1. 1.  
I n di vi d u al  D at a  of  Pl as m a  C o n c e ntr ati o ns
1 6. 2. 3. 3. 2.  
Pl as m a  C o n c e ntr ati o n  V ers us  Ti m e  Pr ofil es
1 6. 2. 3. 3. 2. 1.  
I n di vi d u al  Pl as m a  C o n c e ntr ati o n  V ers us  Ti m e  Pr ofil es – Li n e ar  S c al e
1 6. 2. 3. 3. 2. 2.  
I n di vi d u al  Pl as m a  C o n c e ntr ati o n  V ers us  Ti m e  Pr ofil es – S e mi -L o g arit h mi c 
S c al e
1 6. 2. 3. 3. 3.  
Uri n e  E x cr eti o n
1 6. 2. 3. 3. 3. 1.  
I n di vi d u al  D at a  of  Pl as m a  C o n c e ntr ati o ns
1 6. 2. 3. 3. 4.  
Uri n e  E x cr eti o n  V ers us  Ti m e  Pr ofil es
1 6. 2. 3. 3. 4. 1.  
Uri n e  E x cr eti o n  V ers us  Ti m e  Pr ofil es  – Li n e ar  S c al e
1 6. 2. 3. 4. 
D e m o g r a p hi c  a n d  Ot h e r  B as eli n e  D at a
1 6. 2. 3. 4. 1.  
D e m o gr a p hi c  D at a
1 6. 2. 3. 4. 2.  
F ertilit y/ C o ntr a c e pti o n
1 6. 2. 3. 4. 2. 1.  
F e m al e  F ertilit y/ C o ntr a c e pti o n
1 6. 2. 3. 4. 2. 2.  
M al e  F ertilit y/ C o ntr a c e pti o n
1 6. 2. 3. 4. 3.  
Dr u gs  of  A b us e,  Et h a n ol  a n d  C oti ni n e
1 6. 2. 3. 4. 4.  
Vir al  S er ol o g y  at  S cr e e ni n g
1 6. 2. 3. 4. 5.  
Pr e vi o us  a n d  C o n c o mit a nt  M e di c ati o n
1 6. 2. 3. 4. 6.  
S A R S -C O V -2  T est
1 6. 2. 3. 5. 
C o m pli a n c e
1 6. 2. 3. 5. 1.  
I n v esti g ati o n al  Pr o d u ct  A d mi nistr ati o n
1 6. 2. 3. 6. 
I n di vi d u al  P h a r m a c o ki n eti c  D at a
1 6. 2. 3. 6. 1.  
Gi vi n ost at: I n di vi d u al  P h ar m a c o ki n eti c  D at a
1 6. 2. 3. 6. 1. 1.  
Gi vi n ost at: I n di vi d u al  Dr u g  Pl as m a  C o n c e ntr ati o n  D at a
1 6. 2. 3. 6. 1. 2.  
Gi vi n ost at: I n di vi d u al  Pl as m a  P h ar m a c o ki n eti c  P ar a m et ers
1 6. 2. 3. 6. 1. 3.  
Gi vi n ost at: I n di vi d u al  Pl as m a  P h ar m a c o ki n eti c  Pr ofil es
1 6. 2. 3. 6. 1. 4.  
Gi vi n ost at:  I n di vi d u al  Uri n e  E x cr eti o n  D at a
1 6. 2. 3. 6. 1. 5.  
Gi vi n ost at: I n di vi d u al  Uri n e  P h ar m a c o ki n eti c  P ar a m et ers
1 6. 2. 3. 6. 1. 6.  
Gi vi n ost at: I n di vi d u al  Uri n e  P h ar m a c o ki n eti c  Pr ofil es
1 6. 2. 3. 6. 1. 7.  
Gi vi n ost at:  D o c u m e nt ati o n  of  St atisti c al  A n al ysis
1 6. 2. 3. 6. 1. 7. 1. 
Gi vi n ost at:  Pl as m a  N o n -C o m p art m e nt al  A n al ysis  O ut p ut
1 6. 2. 3. 6. 1. 7. 2.  
Gi vi n ost at:  Pl as m a  N o n -C o m p art m e nt al  A n al ysis  Pl ots
1 6. 2. 3. 6. 1. 7. 3.  
Gi vi n ost at:  Uri n e  N o n -C o m p art m e nt al  A n al ysis  O ut p ut
P P D