Conditions: Intestinal Diseases
Keywords: Albendazole Bioequivalence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 70
Healthy volunteers: yes

Brief summary:
The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.

Detailed description:

Arms:
arm 1: Participants will be administered with test (T) intervention \[Albendazole Indian Pharmacopoeia (IP) 400 mg\] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4. arm 2: Participants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4.

Interventions: intervention 1: Albendazole IP 400 mg intervention 2: Albendazole 400 mg
Intervention descriptions: intervention 1: Albendazole IP 400 mg tablets will be administered under fed conditions intervention 2: Albendazole 400 mg tablets will be administered under fed conditions

Protocol document:
Prot_000.pdf: 
Protocol
Study ID:  221030
Official Title of Study: An Open Label, Balanced, Randomized, Two-
Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate 
Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of 
Biddle Sawyer Limited (GSK group company) with Albendazole Tablets 
400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd 
in Healthy, Adult participants under Fed Condition.
NCT ID: NCT06201559
Date of Document: 04-July-2023


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Clinical Study Protocol 
Primary Study 
Intervention(s) 
Albendazole Tablets IP 400 mg (Test) 
(Composition: Each uncoated tablet contains: Albendazole 
IP 400 mg)  
Name of Manufacturer: Biddle Sawyer Limited C/o 
GlaxoSmithKline Pharmaceuticals Limited, A-10, M.I.D.C 
Ambad-Pathardi Block, Nashik, Nashik - 422010. 
Other Study 
Intervention(s) 
Albendazole Tablets 400 mg (Reference) 
Manufacturer’s Name: Glaxo SmithKline Consumer 
Healthcare, South Africa (PTY) Ltd, Epping Industrial 1, 39 
Hawkins Avenue, CAPE TOWN South Africa. 
Study Identifier 
221030 
Lambda Project No. 
0110-23 
Approval Date 
03 Jul 2023 
Title 
An Open Label, Balanced, Randomized, Two-Treatment, 
Four-Period, Two-Sequence, Single Oral Dose, Full 
Replicate Crossover, Bioequivalence Study of Albendazole 
Tablets IP 400 mg of Biddle Sawyer Limited (GSK group 
company) with Albendazole Tablets 400 mg of Glaxo 
SmithKline Consumer Healthcare, South Africa (PTY) Ltd 
in Healthy, Adult Participants under Fed Condition. 
Compound 
Number/Name  
SKF-62979/ Albendazole  
Brief Title 
Bioequivalence study between two Albendazole 400 mg 
tablets in healthy adult participants under fed conditions. 
Sponsor 
GSK Research & Development Limited 
980 Great West Road, Brentford, Middlesex, TW8 9GS, 
UK 
Sponsor signatory 
Oscar Della Pasqua 
Exec Dir Clinical Pharmacology 
Clinical Pharmacology Modelling and Simulation (CPMS) 
Medical monitor name and contact can be found in local study contact 
information document 
©2023 GSK group of companies or its licensor. 


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Protocol 1.0 Investigator Agreement 
I agree: 
• 
To conduct the study in compliance with this protocol, any future protocol 
amendments, with the terms of the clinical trial agreement and with any other study 
conduct procedures and/or study conduct documents provided by GSK. 
• 
To assume responsibility for the proper conduct of the study at this site. 
• 
That I am aware of and will comply with Good Clinical Practice (GCP) and all 
applicable regulatory requirements.  
• 
That I will comply with the terms of the site agreement. 
• 
To comply with local bio-safety legislation. 
• 
To ensure that all persons assisting me with the study are adequately informed about 
the GSK study intervention and other study-related duties and functions as described 
in the protocol. 
• 
To supervise any individual or party to whom I have delegated study-related duties 
and functions conducted at the study site. 
• 
To ensure that any individual or party to whom I have delegated study-related duties 
and functions conducted at the study site are qualified to perform those study-related 
duties and functions. 
• 
To acquire the reference ranges for laboratory tests performed locally and, if required 
by local regulations, obtain the laboratory’s current certification or Quality Assurance 
procedure manual. 
• 
To ensure that no clinical samples (including serum samples) are retained on-site or 
elsewhere without the approval of GSK and the express physical and/or digital 
informed consent of the participant and/or the participant’s legally authorized 
representative (LAR).   
• 
To perform no biological assays on the clinical samples other than those described in 
the protocol or its amendment(s).  
• 
To co-operate with representative(s) of GSK in the monitoring and data management 
processes of the study with respect to data entry and resolution of queries about the 
data. 
• 
To have control of all essential documents and records generated under my 
responsibility before, during, and after the study. 
• 
That I have been informed that certain regulatory authorities require the sponsor to 
obtain and supply, as necessary, details about the investigator(s)’ ownership interest 
in the sponsor or the study intervention(s), and more generally about their financial 
ties with the sponsor. GSK will use and disclose the information solely for the purpose 
of complying with regulatory requirements. 
 


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Hence, I: 
• 
Agree to supply GSK with any necessary information regarding ownership interest 
and financial ties (including those of my spouse and dependent children). 
• 
Agree to promptly update this information if any relevant changes occur during the 
study and for 1 year following completion of the study. 
• 
Agree that GSK may disclose any information about such ownership interests and 
financial ties to regulatory authorities. 
• 
Agree to provide GSK with an updated Curriculum Vitae and all other documents 
required by regulatory agencies for this study. 


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Study identifier 
Lambda Project No. 
 
 
221030 
0110-23 
 
Approval date 
03 Jul 2023 
Title 
An Open Label, Balanced, Randomized, Two-
Treatment, Four-Period, Two-Sequence, Single Oral 
Dose, Full Replicate Crossover, Bioequivalence 
Study of Albendazole Tablets IP 400 mg of Biddle 
Sawyer Limited (GSK group company) with 
Albendazole Tablets 400 mg of Glaxo SmithKline 
Consumer Healthcare, South Africa (PTY) Ltd in 
Healthy, Adult Participants under Fed Condition. 
Investigator name 
Dr. Dwarkesh Oswal, MD 
Lambda Therapeutic Research Ltd., 
Lambda House, Plot No. 38, Survey No. 388, 
Near Silver Oak Club, S. G. Highway, Gota, 
Ahmedabad - 382 481, Gujarat, India.  
Email: 
  
Signature 
 
 
Date of signature 
(DD Month YYYY) 
 
 
 
 
 
PPD


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TABLE OF CONTENTS 
PAGE 
1. 
PROTOCOL SUMMARY ......................................................................................... 16 
1.1. 
Synopsis ...................................................................................................... 16 
1.2. 
Schema ........................................................................................................ 16 
1.3. 
Schedule of activities (SoA) ........................................................................... 16 
2. 
INTRODUCTION .................................................................................................... 21 
2.1. 
Study rationale .............................................................................................. 21 
2.2. 
Background .................................................................................................. 21 
2.3. 
Benefit/risk assessment .................................................................................. 21 
3. 
OBJECTIVES, ENDPOINTS AND ESTIMANDS ....................................................... 25 
4. 
STUDY DESIGN ..................................................................................................... 28 
4.1. 
Overall design ............................................................................................... 28 
4.2. 
Scientific rationale for study design ................................................................. 29 
4.2.1. 
Participant input into design ............................................................ 29 
4.3. 
Justification for dose ...................................................................................... 29 
4.4. 
End-of-study definition .................................................................................. 30 
5. 
STUDY POPULATION ............................................................................................ 30 
5.1. 
Inclusion criteria ........................................................................................... 30 
5.2. 
Exclusion criteria .......................................................................................... 30 
5.2.1. 
Medical Conditions ........................................................................ 30 
5.2.2. 
Prior/Concomitant Therapy ............................................................. 31 
5.2.3. 
Prior/Concurrent Clinical Study Experience ...................................... 31 
5.2.4. 
Diagnostic Assessments .................................................................. 31 
5.2.5. 
Other Exclusion Criteria .................................................................. 31 
5.3. 
Lifestyle considerations ................................................................................. 32 
5.3.1. 
Meals and dietary restrictions .......................................................... 32 
5.3.2. 
Caffeine, alcohol, and tobacco ......................................................... 32 
5.3.3. 
Activity ......................................................................................... 33 
5.3.4. 
Other restrictions ............................................................................ 33 
5.4. 
Screen failures .............................................................................................. 33 
5.5. 
Criteria for temporarily delaying ..................................................................... 33 
6. 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ............................... 33 
6.1. 
Study intervention(s) administered .................................................................. 33 
6.2. 
Preparation, handling, storage, and accountability ............................................. 34 
6.3. 
Assignment to study intervention .................................................................... 36 
6.4. 
Blinding, masking ......................................................................................... 36 
6.5. 
Study intervention compliance ........................................................................ 36 
6.6. 
Dose modification ......................................................................................... 36 
6.7. 
Continued access to study intervention after the end of the study......................... 36 
6.8. 
Treatment of overdose ................................................................................... 36 
6.9. 
Prior and concomitant therapy ........................................................................ 36 
6.9.1. 
Rescue medicine ............................................................................ 37 


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7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................... 37 
7.1. 
Discontinuation of study intervention .............................................................. 37 
7.1.1. 
Liver chemistry stopping criteria ...................................................... 37 
7.1.2. 
QTc Stopping criteria ..................................................................... 37 
7.1.3. 
Temporary discontinuation .............................................................. 37 
7.1.4. 
Rechallenge ................................................................................... 37 
7.2. 
Participant discontinuation/withdrawal from the study ....................................... 38 
7.3. 
Lost to follow-up........................................................................................... 39 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................... 39 
8.1. 
Administrative procedures .............................................................................. 40 
8.1.1. 
Collection of demographic data ........................................................ 40 
8.1.2. 
Medical/vaccination history ............................................................. 40 
8.2. 
Pharmacokinetic assessments .......................................................................... 41 
8.3. 
Safety assessments ........................................................................................ 41 
8.3.1. 
Physical/Clinical examination and clinical safety measures ................. 41 
8.3.2. 
Vital signs ..................................................................................... 41 
8.3.3. 
Electrocardiograms ......................................................................... 42 
8.3.4. 
Clinical safety laboratory tests ......................................................... 42 
8.3.5. 
Pregnancy testing ........................................................................... 43 
8.3.6. 
Safety Measures for Volunteers during Covid-19 pandemic ................. 43 
8.3.7. 
Study stopping rules/holding rules, safety monitoring AND/OR 
Committee ..................................................................................... 43 
8.4. 
Adverse Events (AEs) serious adverse events (SAEs), and other safety 
reporting ...................................................................................................... 43 
8.4.1. 
Time period and frequency for collecting AE, SAE, and other 
safety information .......................................................................... 44 
8.4.2. 
Method of detecting AEs and SAEs .................................................. 44 
8.4.3. 
Follow-up of AEs and SAEs ............................................................ 44 
8.4.4. 
Regulatory reporting requirements for SAEs ...................................... 45 
8.4.5. 
Pregnancy ..................................................................................... 49 
8.4.6. 
Cardiovascular (CV) and death events .............................................. 49 
8.4.7. 
Disease-related events and/or disease-related outcomes not 
qualifying as AEs or SAEs .............................................................. 49 
8.4.8. 
Contact information for reporting SAEs, Pregnancies ......................... 49 
8.5. 
Pharmacokinetics .......................................................................................... 49 
Pharmacokinetic Analysis .............................................................................. 49 
8.6. 
Pharmacodynamics ........................................................................................ 54 
8.7. 
Genetics ....................................................................................................... 54 
8.8. 
Biomarkers ................................................................................................... 54 
8.9. 
Immunogenicity assessments .......................................................................... 54 
9. 
STATISTICAL CONSIDERATIONS ......................................................................... 55 
9.1. 
Statistical Hypotheses .................................................................................... 55 
9.2. 
Multiplicity Adjustment ................................................................................. 56 
9.3. 
Analysis sets ................................................................................................. 56 
9.4. 
Statistical Analysis ........................................................................................ 56 
9.4.1. 
General considerations .................................................................... 56 
9.4.2. 
Primary Endpoint(s)/Estimand(s) Analysis ........................................ 57 
9.4.3. 
Secondary Endpoint(s)/Estimand(s) Analysis ..................................... 59 
9.4.4. 
Safety Analysis .............................................................................. 60 


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9.5. 
Interim analyses ............................................................................................ 60 
9.6. 
Sample size determination .............................................................................. 60 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................ 62 
10.1. 
Appendix 1: Regulatory, ethical, and study oversight considerations ................... 63 
10.1.1. 
Regulatory and ethical considerations ............................................... 63 
10.1.2. 
Financial disclosure ........................................................................ 64 
10.1.3. 
Informed consent process ................................................................ 64 
10.1.4. 
Recruitment strategy ....................................................................... 64 
10.1.5. 
Data protection .............................................................................. 65 
10.1.6. 
Committees structure ...................................................................... 65 
10.1.7. 
Dissemination of Clinical Study Data ............................................... 65 
10.1.8. 
Data quality assurance .................................................................... 66 
10.1.9. 
Source documents .......................................................................... 67 
10.1.10. Study and site start and closure ........................................................ 68 
10.1.11. Publication policy .......................................................................... 68 
10.2. 
Appendix 2: Clinical laboratory tests ............................................................... 69 
10.3. 
Appendix 3: AEs and SAEs: Definitions and procedures for recording, 
evaluating, follow-up, and reporting ................................................................ 71 
10.3.1. 
Definition of AE ............................................................................ 71 
10.3.2. 
Definition of SAE .......................................................................... 72 
10.3.3. 
Definition of CV events .................................................................. 73 
10.3.4. 
Definition of TEAE ........................................................................ 73 
10.3.5. 
Recording, assessment and follow-up of AE, SAE and 
pregnancies ................................................................................... 73 
10.4. 
Appendix 4: Contraceptive and barrier guidance ............................................... 79 
10.4.1. 
Definitions .................................................................................... 79 
10.5. 
Appendix 5: Liver safety: suggested actions and follow-up assessments ............... 80 
10.6. 
Appendix 6: Clinically acceptable values ......................................................... 81 
10.7. 
Appendix 7: High fat high calorie vegetarian breakfast menu ............................. 84 
11. REFERENCES ......................................................................................................... 86 
 


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LIST OF TABLES 
PAGE 
Table 1 
Schedule of Activities – Overview Across Periods ........................................ 17 
Table 2 
Schedule of Activities – Detailed View within Period ................................... 20 
Table 3 
Potential risks and risk mitigation strategies ................................................. 22 
Table 4 
Objectives and Endpoints .......................................................................... 25 
Table 5 
Study Intervention(s) Administered ............................................................ 33 
Table 6 
Differences between Test and Reference tablets ........................................... 34 
Table 7 
Timeframes for submitting SAE, pregnancy and other events 
reports to GSK, Ethics Committee and CDSCO ..................................... 46 
Table 8 
Contact information for reporting SAEs, pregnancies ............................. 49 
Table 9 
PK sampling schedule ............................................................................... 52 
Table 10 
Covariance matrix used for Cmax and AUC(0-t) in power 
calculations ............................................................................................ 61 
Table 11 
Joint power calculation results (N=1000) across various 
scenarios of missing data ....................................................................... 61 
Table 12 
Protocol-required safety laboratory tests ................................................ 69 
LIST OF FIGURES 
Figure 1 
Study design overview .............................................................................. 16 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS  
 
Abbreviation 
Definition 
AE 
Adverse event 
ADE 
Adverse device effect 
ABE 
Average bioequivalence 
ADR 
Adverse drug reaction 
AE 
Adverse event 
AESI 
Adverse event of special interest 
AUC 
Area under the plasma concentration-time curve  
AUC0-t 
Area under the plasma concentration-time curve up to the last 
measured time point 
AUC0-∞ 
Area under the plasma concentration-time curve extrapolated to 
infinite time 
AUC_%Extrap_obs Percentage of AUC that is extrapolated 
AxMP 
Auxiliary medicinal product 
BE 
Bioequivalence 
BMI 
Body mass index 
CDSCO 
Central Drugs Standard Control Organization 
CIOMS 
Council for International Organizations of Medical Sciences 
Cmax 
Maximal (peak) plasma concentration 
COA 
 Certificates of analysis 
COVID-19 
Coronavirus Disease 2019 
CPMS 
Clinical Pharmacology Modeling and Simulation 
CPSB 
Consumer Product Safety Board 
CRF/eCRF 
Case report form/electronic case report form 


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Abbreviation 
Definition 
CSI 
Core safety information 
CSR 
Clinical study report 
CV 
Cardiovascular 
CVW 
Coefficient of variation 
CV% 
Intra-subject variability 
ECG 
Electrocardiogram 
ED 
Early discontinuation 
EoS 
End-of-study 
FDA 
Food and Drug Administration, United States of America 
FSH 
Follicle stimulating hormone 
FSFV 
First subject first visit 
GAELF 
Global Alliance to Eliminate Lymphatic Filariasis 
GCP 
Good clinical practices 
GDS 
Global Data Sheet 
GLM 
General linear model 
GMO 
Genetically modified organism 
GMP 
Good manufacturing practice 
GMR 
Geometric mean ratio 
HCV 
Hepatitis C virus 
HbsAg 
Hepatitis B surface antigen 
HIPAA 
Health Insurance Portability and Accountability Act 
HRT 
Hormonal replacement therapy 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 


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Abbreviation 
Definition 
ICMJE 
International Committee of Medical Journal Editors 
ICMR 
Indian Council of Medical Research 
IDFU 
Investigational directions for use 
IEC 
Independent ethics committee 
IM 
Intramuscular 
IMP 
Investigational medicinal product 
IMPD 
Investigational medicinal product dossier 
IND 
Investigational New Drug 
IRB 
Institutional review board 
λz 
Slope of the (terminal) log-lin phase of the plasma 
concentration-time curve 
LAR 
Legally acceptable representative 
LSLV 
Last Subject Last Visit 
MDA 
Mass drug administration 
MSR 
Medical Screening Record 
NIMP 
Non-investigational medicinal product 
NQ 
Non-quantifiable 
OTC 
Over the counter 
POAP 
Pregnancy Outcome Advisory Panel 
POM 
Prescription only medicine 
PK 
Pharmacokinetic 
PP 
Per protocol 
QTL 
Quality tolerance limit 
SADE 
Serious adverse device effect 


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Abbreviation 
Definition 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SCABE 
Scaled average bioequivalence 
SoA 
Schedule of activities 
SOP 
Standard operating procedure 
SRT 
Safety Review Team 
σWR 
Within-subject standard deviation  
TEAE 
Treatment-emergent adverse event 
Tmax 
Time of peak concentration 
TOC 
Table of contents 
TOST 
Two one-sided t-test 
T1/2 
Half-life 
USA 
United States of America 
USADE 
Unanticipated serious adverse device effect 
WBC 
White blood cell 
WHO 
World Health Organization 
WOCBP 
Woman of childbearing potential 
WONCBP 
Woman of nonchildbearing potential 
 
 
 


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Term 
Definition 
Certified copy 
A copy (irrespective of the type of media used) of the 
original record that has been verified (i.e. by a dated 
signature or by generation through a validated process) to 
have the same information, including data that describe 
the context, content, and structure, as the original. 
Combination product 
Combination product comprises any combination of  
− 
drug  
− 
device  
− 
biological product  
Each drug, device and biological product included in a 
combination product is a constituent part.  
Decentralized Trial 
Platform 
A digital engagement technology allowing for the remote 
delivery and access to trials for sponsors.  
Eligible 
Qualified for enrollment into the study based upon strict 
adherence to inclusion/exclusion criteria. 
Essential documents 
Documents which individually and collectively permit 
evaluation of the conduct of a study and the quality of the 
data produced 
Intervention number 
A number identifying an intervention to a participant, 
according to intervention allocation. 
Investigational medicinal 
An IMP is a pharmaceutical form of an active substance 
or placebo being tested or used as a reference in a clinical 
study, including products already with a marketing 
authorization but used or assembled (formulated or 
packaged) in a way different from the authorized form, or 
when used for an unauthorized indication, or when used 
to gain further information about the authorized form. 
Medicinal products with a marketing authorization are 
IMPs when they are to be used as the test substance, 
reference substance, or comparator in a clinical study, 
provided the requirement(s) in the definition is/are met. 
Investigator 
A person responsible for the conduct of the clinical study 
at a study site. If a study is conducted by a team of 
individuals at a study site, the investigator is the 
responsible leader of the team and may be called the 
principal investigator.  


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Term 
Definition 
The investigator can delegate study-related duties and 
functions conducted at the study site to qualified 
individual or party to perform those study-related duties 
and functions 
Legally acceptable 
representative 
An individual, judicial or other body authorized under 
applicable law to consent on behalf of a prospective 
participant to the participant's participation in the clinical 
study. 
The terms legal representative or legally authorized 
representative are used in some settings. 
NIMP/AxMP 
A NIMP or AxMP is a medicinal product that is not 
classified as an IMP in a study, but may be taken by 
participants during the study, e.g., concomitant or 
rescue/escape medication used for preventive, diagnostic, 
or therapeutic reasons or medication given to ensure that 
adequate medical care is provided for the participant 
during a study. 
Participant number 
A unique identification number assigned to each 
participant who consents to participate in the study. 
Participant 
Term used throughout the protocol to denote an 
individual who has been contacted to participate or who 
participates in the clinical study as a recipient of the study 
intervention (vaccine(s)/product(s)/control). 
Synonym: subject 
Randomization 
Process of random attribution of intervention to 
participants to reduce selection bias. 
Self-contained study 
Study with objectives not linked to the data of another 
study. 
Source data 
All information in original records and certified copies of 
original records of clinical findings, observations, or 
other activities in a clinical study necessary for the 
reconstruction and evaluation of the study. Source data 
are contained in source documents (original records or 
certified copies). 


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Term 
Definition 
Study intervention 
Term used throughout the clinical study to denote a set of 
investigational product(s) or marketed product(s) or 
placebo intended to be administered to a participant. 
Note: “Study intervention” and “study treatment” are 
used interchangeably unless otherwise specified. 
Study completion date 
The date on which the last participant in a clinical study 
was examined or received an intervention/treatment to 
collect 
final 
data 
for 
the primary 
outcome 
measures, secondary outcome measures, and AEs (that 
is, the last participant's last visit or LSLV). 
Study monitor 
An individual assigned by the sponsor and responsible for 
assuring proper conduct of clinical studies at 1 or more 
investigational sites. 


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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol Title: An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, 
Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of 
Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK group company) with 
Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa 
(PTY) Ltd in Healthy, Adult participants under Fed Condition. 
Brief Title: Bioequivalence study between two albendazole 400 mg tablets in healthy, 
adult participants under fed conditions. 
Rationale: Refer to Section 2.1. 
Objectives, Endpoints, and Estimands: Refer to Section 3. 
Overall Design: Refer to Section 4.1. 
Number of Participants: Refer to Section 9.6. 
Data Monitoring/Other Committee: Refer to Section 10.1.6. 
1.2. 
Schema 
Based on US FDA guidance , this study will employ 2 sequences in a 4-period cross-over 
design, i.e. T-R-T-R and R-T-R-T (T=test study intervention, R=reference study 
intervention).  
Figure 1 
Study design overview 
 
 
 
1.3. 
Schedule of activities (SoA) 
 
Period 
I
Period 
II
Period 
III
Period 
IV
Subject
Randomi
zation
Seque
nce 1
Test
Refere
nce
Test
Refere
nce
End of Study 
(EOS)
Seque
nce 2
Refere
nce
Test
Refere
nce
Test
Washou
t
Washou
t
Washou
t


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Table 1 
Schedule of Activities – Overview Across Periods 
Procedure 
Screening  
(up to 28 days 
before Dosing in 
period I) 
Period I 
Period II, III and IV 
 
ED = early 
discontinuation
/ withdrawal 
Reference section  
Day 
 
-1 
1 
2 
-1 
1 
2 
 
 
Informed consent 
● 
(Consent for 
screening) 
● 
(Study 
specific 
consent) 
 
 
 
 
 
 
[See Section 10.1.3 for 
details] 
Inclusion and 
exclusion criteria 
 
● 
 
 
 
 
 
 
[ See Section 5.1 and 
Section 5.2 for Inclusion 
and Exclusion criteria] 
Demography 
● 
 
 
 
 
 
 
 
[See Section 8.1.1 for 
more information] 
Compliance 
Assessment 
 
● 
 
 
● 
 
 
 
[See Section 5.3.1, 
Section 5.3.2 for more 
information] 
Height and weight 
● 
 
 
 
 
 
 
 
[See Section 8.3.1 for 
more information] 
Physical examination/ 
clinical examination 
● 
● 
 
● 
● 
 
● 
 
[See Section 8.3.1 for 
more information] 
Medical history  
● 
 
 
 
 
 
 
 
[See Section 8.1.2 for 
more information] 
Urine Drug Screening, 
breath alcohol Test 
● 
● 
 
 
● 
 
 
 
Substances: [Drugs, 
Alcohol, tobacco and 
caffeine] 


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Procedure 
Screening  
(up to 28 days 
before Dosing in 
period I) 
Period I 
Period II, III and IV 
 
ED = early 
discontinuation
/ withdrawal 
Reference section  
Day 
 
-1 
1 
2 
-1 
1 
2 
 
 
Serum Pregnancy Test 
(for females only)  
● 
● 
 
 
● 
 
* 
● 
[See to Section 8.3.5– 
pregnancy testing for 
instruction on 
timepoints] 
Serology Tests [HIV, 
Hepatitis B and C 
screening]+ 
● 
 
 
 
 
 
 
 
[See Section 8.3.4, 
Section 10.2 for more 
information] 
Laboratory 
assessments + 
● 
 
 
 
● 
 
* 
● 
[See Section 8.3.4, 
Section 10.2 for more 
information] 
12-lead ECG 
● 
 
 
 
 
 
 
 
[See Section 8.3.3 for 
more information] 
Chest X-ray$ 
● 
 
 
 
 
 
 
 
[See Section 8.3.1 for 
more information] 
Pre dose vital signs 
 
 
● 
 
 
● 
 
 
[See Section 8.3.2 for 
more information] 
Post dose Vital signs% 
 
 
● 
 
 
● 
 
 
[See Section 8.3.2 for 
more information] 
Check-in 
 
● 
 
 
● 
 
 
 
 
Administration of 
study intervention 
 
 
● 
 
 
● 
 
 
[See Section 6.1 for 
more information] 
Blood Collection for 
PK Analysis # 
 
 
● 
● 
 
● 
● 
 
[See Section 8.5 for 
more information] 


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Procedure 
Screening  
(up to 28 days 
before Dosing in 
period I) 
Period I 
Period II, III and IV 
 
ED = early 
discontinuation
/ withdrawal 
Reference section  
Day 
 
-1 
1 
2 
-1 
1 
2 
 
 
AE review 
 
 
● 
● 
● 
● 
● 
 
[See Section 10.3.5, 
Section 8.4 for more 
information] 
SAE review 
 
● 
● 
● 
● 
● 
● 
 
[See Section 10.3.5, 
Section 8.4 for more 
information] 
Concomitant 
medication review 
 
 
● 
● 
● 
● 
● 
 
[See Section 6.9 for 
more information] 
HIV: human immunodeficiency virus, ECG: electrocardiogram, PK: pharmacokinetic, AE: adverse event, SAE: serious adverse event, (e)CRF: (electronic) case 
report form 
● Is used to indicate a study procedure that requires databasing (either in eCRF, device, laboratory or other third-party vendor). 
* End study safety assessment (i.e. at the time of check-out of period IV) 
+ Clinical Laboratory tests will be performed as per Section 10.2: Clinical laboratory tests 
(Meals will be provided to the participants as mentioned in the protocol) 
$ Chest X-ray is valid up to 6 months including the day of first dosing. 
# The venous blood samples will be drawn at 0.00 (Pre-dose) and at 0.33 (0h20min), 0.67  (0h40min), 1.00 (1h00min), 1.33 (1h20min), 1.67 (1h40min), 2.00 
(2h00min), 2.33 (2h20min), 2.67 (2h40min), 3.00 (3h00min), 3.33 (3h20min), 3.67 (3h40min), 4.00 (4h00min), 4.50 (4h30min), 5.00 (5h00min), 6.00 (6h00min), 
8.00 (8h00min), 10.00 (10h00min), 12.00 (12h00min), 14.00 (14h00min), 18.00 (18h00min), 24.00 (24h00min) post dose in each period.  
%Post-dose vitals will be recorded at 2, 4, 6, 12 and 24 hours post-dose in each period. 
- 
Check-in day (Day -1)  
- 
Dosing Day (Day 1) 
- 
Housing Day (Day -1 to 2)  
- 
Check-out Day (Day 2, morning) 
- 
End Study (i.e. at the time of check-out of period IV) 
 
 


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Table 2 
Schedule of Activities – Detailed View within Period 
Procedures 
 
Time (h) in relation to 
albendazole dose 
0 
(Pre-dose) 
0.33, 
0.67, 
1.00, 
1.33, 
1.67 
2.00 
2.33, 
2.67, 
3.00, 
3.33, 
3.67 
4.00 
4.50, 
5.00,  
6.00 
8.00, 
10.00 
12.00 
14.00 
18.00 
Next day  
24.00 
(Discharge) 
AE/SAE assessment 
 
Vital signs 
 
 
X 
 
X 
 
X 
 
X 
 
 
X 
Blood collection for PK Analysis 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discharge 
 
 
 
 
 
 
 
 
 
 
 
X 
PK: pharmacokinetic, AE: adverse event, SAE: serious adverse event 
 


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2. 
INTRODUCTION 
2.1. 
Study rationale 
This study is being conducted to address the World Health Organization (WHO) Medicines 
prequalification requirements for the registration of an albendazole formulation, to be 
provided to the WHO global health program, manufactured at a new facility. Its primary 
aim is to assess the bioequivalence between the Sponsor’s test study intervention and the 
reference study intervention after single oral dose administration in healthy adult 
participants under fed conditions. In addition, it compares the pharmacokinetic profile and 
safety between test and reference intervention. The current product being provided to WHO 
as part of the global health program was chosen as the comparator (reference) product. This 
product is comparable to the product marketed in regulated countries (Zentel, Eskazole) 
with respect to formulation, manufacturing process, site of manufacture, and methods with 
the exception of the addition of a colouring agent in the product formulation. 
2.2. 
Background 
Albendazole is a benzimidazole carbamate with antiprotozoal and anthelmintic effects 
against intestinal and tissue parasites. Albendazole exhibits larvicidal, ovicidal and 
vermicidal activity, and it is thought to exert its anthelmintic effect by inhibiting tubulin 
polymerization. This causes the disruption of the helminth metabolism, including energy 
depletion, which immobilizes and then kills the susceptible helminth. 
 
Pharmacokinetics: 
In humans, albendazole is poorly absorbed (less than 5%) following oral administration, 
but its absorption is greatly enhanced (approximately 5-fold) when taken with fat-rich food. 
After absorption, albendazole rapidly undergoes extensive first-pass metabolism in the 
liver resulting in several metabolites of which albendazole sulfoxide is its main metabolite. 
Peak concentrations are achieved for albendazole approximately 2 hours after dose, and 
for albendazole sulfoxide approximately 4 hours after dose. The T1/2 of albendazole is 
approximately 1.5 hours and for albendazole sulfoxide 8.5 hours. 
For gastro-intestinal infections, the parent compound albendazole is considered the active 
moiety, whereas for systemic infections this is albendazole sulfoxide. For the purpose of 
determining bioequivalence, however, the WHO requires this to be shown for the 
albendazole parent compound. 
 
2.3. 
Benefit/risk assessment 
Participation in bioavailability studies yields no direct benefit to the participants. However, 
a charge-free study related health assessment is provided. The risks as described below are 
reduced considering the fact only 4 doses are to be administered at an interval of at least 7 
days between dosing days of any 2 successive periods. 


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Table 3 
Potential risks and risk mitigation strategies 
The potential risks of clinical significance for albendazole tablets are derived from the 
prescribing information (Albendazole label). Most of these reported risks are uncommon, 
rare or very rare. The likelihood of these risks in a healthy population receiving a single 
dose is therefore expected to be low. For complete list of adverse reactions please refer 
the prescribing information mentioned above. 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention(s) 
Hepatotoxicity 
In 2001, GSK routine 
monitoring of spontaneous 
ADRs identified an 
increased number of 
reports of elevated liver 
enzymes in patients 
receiving low dose 
albendazole and reports of 
hepatitis and jaundice in 
patients receiving high 
dose albendazole. Higher 
doses of albendazole are 
used to treat systemic 
helminth infections for 
longer periods compared to 
the low dose, short 
treatment durations 
required for intestinal 
helminth infections in the 
OTC environment. A 
cumulative review of 
hepatic events was 
conducted to further 
evaluate the nature of these 
events and to determine 
whether GSK’s CSI 
adequately reflected these 
adverse events. Following 
the review of the available 
data, GSK concluded that 
there was sufficient 
evidence to suspect 
albendazole as causing 
hepatic events; with low 
dose albendazole causing 
This study will not include 
participants with abnormal 
liver function test results 
(transaminases). 
Discontinuation of study 
intervention in the best 
interest of the participant 
for abnormal liver tests at 
the investigator discretion, 
when liver parameter falls 
outside the pre-defined 
clinically acceptable 
values.  
If any participant has 
clinically significant 
abnormal liver function 
analysis during the study, 
in such case participant 
may be discontinued for 
specific period at the 
investigator discretion. The 
decision to 
continue/discontinue such 
participants will be based 
on investigator’s decision. 
 


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Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
elevation of liver enzymes 
and the high dose use 
causing hepatitis. The CSI 
for POM albendazole 
global data sheet (GDS) 
was therefore updated to 
include these events in the 
Adverse Reactions section 
as well as appropriate 
warnings in the Dosing and 
Administration and 
Warnings and Precautions 
sections 
Exposure during pregnancy Pre-Clinical Data in 
common with other 
benzimidazole compounds, 
administration of 
albendazole to pregnant 
animals can cause 
abnormalities of foetal 
development, including 
increased embryo 
resorption, soft tissue 
malformation and skeletal 
deformities. This 
teratogenic and 
embryotoxic activity has 
led to the recommendation 
that albendazole must not 
be prescribed to females 
who are pregnant. Post 
marketing surveillance in 
2012, the GSK POAP 
reviewed all relevant new 
data in a context specific 
manner with a view to 
providing an assessment on 
the use of albendazole (and 
mebendazole another 
benzimidazole, which is 
structurally and 
physiologically similar to 
albendazole) for the 
treatment of intestinal 
Albendazole is 
contraindicated in 
pregnancy and should not 
be administered during 
pregnancy or in women 
thought to be pregnant. 
Pregnant women will not 
be included. 
Serum Pregnancy test for 
female participants will be 
done at the time of 
screening, prior to check-in 
of each period and at the 
end of the study (at the 
time of check-out of period 
IV). Pregnancy testing 
must be done even if the 
participant is menstruating 
at the time of the study 
visit. The study 
intervention may only be 
administered if the 
pregnancy test is negative. 
For female participants 
history of menstruation and 
use of contraceptive 
methods will be evaluated 
by trained study physician 
at the time of screening. 


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Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
infections during various 
exposure scenarios in 
pregnancy. POAP 
considered the Weight-of-
Evidence of all the 
reported pregnancy 
outcomes relative to all 
trimesters of pregnancy. 
The data reviewed included 
16 publications (including 
meta-analyses) involving 
drug exposures to over 
12,000 pregnant women 
(albendazole: N=6000; 
mebendazole: N=6000). 
Subsequent to the POAP 
consultation on the use of 
albendazole during 
pregnancy, the GSK CPSB 
decided that there was 
insufficient evidence to 
remove the 
contraindication regarding 
use during pregnancy in 
the OTC setting 
Female participants who 
become pregnant after the 
first study intervention 
dose must not receive 
subsequent doses of the 
study intervention and will 
be withdrawn from the 
study. 
 
Neurological disorders 
The neurological disorders 
include headache and 
dizziness are listed in the 
adverse reaction section.  
 
Considering single oral 
dose of albendazole with 1-
week interval between the 
doses, headache and 
dizziness subsides on its 
own before the next period 
starts. 
If these symptoms continue 
during II, III and IV period 
admission, withdrawal of 
participant can be 
considered based on 
principal investigator 
decision and condition of 
participant. 
 
 


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3. 
OBJECTIVES, ENDPOINTS AND ESTIMANDS 
Table 4 
Objectives and Endpoints  
Objectives 
Endpoints 
Primary 
  
• To evaluate if Test Study Intervention 
(T): Albendazole tablets IP 400 mg, 
manufactured by Biddle Sawyer 
Limited is bioequivalent to Reference 
Study Intervention (R): Albendazole 
Tablets 400 mg, manufactured by GSK 
Consumer Healthcare, South Africa 
(PTY) 
• Albendazole Cmax and 
AUC(0-t) 
Secondary 
  
• To assess secondary pharmacokinetic 
parameters of Test Study Intervention 
(T): Albendazole tablets IP 400 mg 
relative to Reference Study 
Intervention (R): Albendazole tablets 
400 mg. 
• Albendazole AUC0-∞, Tmax, 
t1/2, lambda-z (λz) and 
AUC_%Extrap_obs. 
• Albendazole sulfoxide Cmax, 
AUC(0-t), AUC0-∞, Tmax, 
t1/2, lambda-z (λz) and 
AUC_%Extrap_obs. 
• To assess the safety and tolerability of 
a single oral dose of the test versus the 
reference study intervention. 
• Incidence of AE. 
• Absolute and change from 
baseline in vital signs 
parameters at each timepoint. 
Primary estimand/coprimary estimands 
The primary clinical question of interest is: 
To evaluate if Test Study Intervention (T): Albendazole tablets IP 400 mg is 
bioequivalent to Reference Study Intervention (R) Albendazole tablets 400 mg in 
healthy adult participants under fed conditions. 
The estimand is described by the following attributes: 
  


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• 
Population: Healthy adult participants between 18 to 45 years of age. 
• 
Treatment condition: Single dose of Albendazole tablets IP 400 or Albendazole 
tablets 400 mg, each treatment period given under fed conditions to healthy 
participants. 
• 
Variable/endpoint: Cmax and AUC(0-t) 
• 
Summary measure: 
o Treatment ratios of geometric least square means with 90% CI, and within-subject 
coefficient of variation of reference study intervention (intra-subject CV in %).  
• 
Intercurrent events: 
o Permanent Treatment discontinuation due to any reason (includes COVID-19 
positive, AE related withdrawal etc.) – While-on treatment strategy that is, all 
available data up until the withdrawal of the consent will be reported. 
o Use of prohibited or rescue medication (Section 6.9) which could affect PK 
parameters (Cmax and AUC(0-t)) during the study – Hypothetical strategy  
Experiences emesis/vomiting before 2 times of median Tmax (i.e. 2 x 2hour = 
4hour) after dose administration – Hypothetical strategy. 
• 
Rationale for estimand: 
o The rationale of the while on treatment strategy is to estimate the PK parameters 
when participants have taken the dose/treatment condition. 
o The rationale of hypothetical strategy for prohibited/rescue medication is to 
minimize the potential confounding of PK data (Cmax and AUC(0-t)). It attempts 
to estimate treatment effects had the intercurrent event not occurred. In this 
scenario, if the intercurrent event occurred before 2 times median Tmax (i.e. 2 x 
2hour = 4hour) after study drug administration, PK parameters (Cmax and AUC(0-
t)) data would be set to be missing for that period. 
o Hypothetical strategy would be considered if emesis/vomits occur before 2 times 
the median Tmax (i.e. 2 x 2hour = 4hour) after study drug administration in 
particular period, this is because the drug would not have been absorbed into the 
body. In this situation, PK parameters (Cmax and AUC(0-t)) data would set to be 
missing for that period. 
 
Secondary estimand(s) - PK endpoint 
The secondary clinical question of interest is: 
To assess secondary pharmacokinetic parameters of Test Study Investigation (T): 
Albendazole tablets IP 400 mg relative to Reference Study Investigation (R): 
Albendazole tablets 400 mg. 
  
The estimand is described by the following attributes: 
• 
Population: Healthy adult participants between 18 to 45 years of age. 


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• 
Treatment condition: Single dose of Albendazole tablets IP 400 mg or 
Albendazole tablets 400 mg, each treatment period given under fed conditions to 
healthy participants. 
• 
Variable/endpoint:  
• 
Albendazole AUC0-∞, Tmax, t1/2, λz and AUC_%Extrap_obs. 
• 
Albendazole sulfoxide Cmax, AUC(0-t), AUC0-∞, Tmax, t1/2, λz and 
AUC_%Extrap_obs. 
• 
Summary measure: 
Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, SD, 
median, minimum, maximum and geometric mean) will be presented for 
untransformed secondary PK parameters (AUC0-∞, AUC(0-t), Tmax, t1/2, λz and 
AUC_%Extrap_obs). 
• 
Intercurrent events: 
o Same as primary endpoint 
 
• 
Rationale for estimand: 
o The rationale of hypothetical strategy which is impacted to secondary PK 
parameters (AUC0-∞, AUC(0-t), Tmax, t1/2, λz and AUC_%Extrap_obs) during 
the study is same as primary estimands. 
 
Secondary estimand(s) - 2(Safety) 
The secondary clinical question of interest is: 
To assess the safety and tolerability of a single oral dose of Test Study Intervention 
(T):  
Albendazole tablets IP 400 mg relative to Reference Study Intervention (R): 
Albendazole tablets 400 mg. 
  
The estimand is described by the following attributes: 
  
• 
Population: Healthy adult participants between 18 to 45 years of age. 
• 
Treatment condition: Single dose of Albendazole tablets IP 400 mg or 
Albendazole tablets 400 mg, each treatment period given under fed conditions for 
healthy participants. 
• 
Variable/endpoint: Incidence of AE and Absolute and change from baseline in 
vital signs parameters at each timepoint. 
• 
Summary measure: 
o Number and percentage will be presented for incidence of AE. 


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o Descriptive statistics (N, n, mean, SD, median, minimum and maximum) will be 
presented for absolute and change from baseline values of vital signs parameters at 
each timepoint. 
• 
Intercurrent events: 
Permanent Treatment discontinuation due to any reason (includes COVID-19 
positive, AE related withdrawal etc.) – Treatment policy strategy. 
• 
Rationale for estimand: 
Permanent Treatment discontinuation due to any reason will be handled with a 
treatment policy strategy as occurrence of AE until participant are on study will 
be collected and reported. 
4. 
STUDY DESIGN 
4.1. 
Overall design 
Study Design: 
An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, 
Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets 
IP 400 mg of Biddle Sawyer Limited (GSK group company) with Albendazole Tablets 400 
mg of GSK Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants 
under Fed Condition. 
Housing:  
Participants will be housed in the clinical facility at least 11 hours before administration of 
the intervention and will continue to remain in the clinical facility for at least 24 hours after 
administration of the intervention in each period.  
The participants will have to stay in the facility for 2 consecutive nights in each period.  
In case of any adverse event, necessary action will be taken till the event subsides. 
Wash-out Period: 
There will be a washout period of at least 7 days between dosing days of any 2 consecutive 
periods. 
Dosing: 
Dose administration as described below will be done under the supervision of trained study 
personnel. 
After an overnight fast of at least 10 hours, participants will be served high fat high calorie 
vegetarian breakfast 30 minutes prior to dosing, which they are required to consume within 
30 minutes (Section 5.3.1). Study Intervention will be administered to the participants 
while in sitting position with 240 ± 2 mL of drinking water at the ambient temperature in 
each period. The tablets should be swallowed whole without chewing or crushing.  
This activity will be followed by a thorough mouth check with torch & disposable spatula 
by the trained study personnel immediately after study intervention administration to assess 
compliance to dosing. The time of administration of the study intervention will be the time 


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at which the participant completes drinking 240 ± 2 mL of water and that will be captured 
in the respective source data forms. 
 
4.2. 
Scientific rationale for study design 
The manufacturing of albendazole tablets is being transferred from Cape Town, South 
Africa to Nashik, India. To ensure appropriate exposure after administration of the newly 
produced tablets from India, bioequivalence is required to be proven between the tablets 
from both locations. Therefore, this study evaluates the bioequivalence between the 
Sponsor’s test study intervention (albendazole 400 mg tablets from Nashik, India) with 
respect to the reference study intervention (albendazole 400 mg tablets from Cape Town, 
South Africa) in healthy adult participants under fed condition.  
Albendazole is a molecule with high intra-subject variability supported from literature2 and 
in-house experience. Additionally, as per WHO product specific guidance (Notes on the 
Design of Bioequivalence Study: Albendazole; 29 March 2021), albendazole PK in the fed 
state is highly variable (up to 68% for Cmax and 62% for AUC). The WHO guideline for 
albendazole bioequivalence studies strongly recommends a replicate cross-over study 
design for albendazole bioequivalence studies, to estimate intra-subject PK variability 
more accurately which allows to widen the acceptance range for Cmax and AUC(0-t) 
ratios. Given the large variability in albendazole and albendazole sulfoxide PK, such 
potential larger differences in Cmax and AUC(0-t) between the proposed product and the 
comparator that might be accepted due to the widened acceptance range are expected to 
lack clinical relevance. In line with the WHO product specific guidance document, this 
study implements a fully replicate 4-period study design.  
The PK sampling and washout period of 7 days are designed to ensure that PK parameters 
will be well-estimated and pre-dose concentrations are negligible in each subsequent 
period. 
Depending on the CV% in Cmax and AUC(0-t), a joint power calculation showed that 48 
evaluable participants were required to achieve a joint power of at least 90% for the two 
primary endpoints. Taking into account an expected dropout with fully missing data in up 
to 30% of participants, a total of 70 healthy adult participants will be enrolled. In case of 
only partially missing data in those 30%, the joint power of this study may be over 90% 
(Section 9.6). 
4.2.1. 
Participant input into design 
4.3. 
Justification for dose 
The average daily dose of albendazole is 400 mg up to 2 times a day. This is taken as one 
400 mg tablet up to 2 times per day with a maximum dose of 800 mg per day. 
This study will be assessing the bioequivalence of a single dose of Albendazole Tablets IP 
400 mg or Albendazole Tablets 400 mg in each period under fed conditions, according to 
a 4-period, 2-sequence full replicate crossover design bioequivalence study with a washout 
period of 7 days. 


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4.4. 
End-of-study definition 
A participant is considered to have completed the study if the participant has completed all 
periods of the study including the last scheduled procedure shown in the SoA (i.e. at the 
time of check-out of period IV). 
Thus, the end of study will be the last scheduled procedure (blood collection for PK sample 
and safety assessment at the time of check-out of period IV) of the last participant in the 
study.  
5. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, 
also known as protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion criteria 
Participants are eligible to be included in the study only if all of the following criteria 
apply: 
a) Non-smoker, healthy, adult human participants between 18 to 45 years of age (both 
inclusive). 
b) Having a BMI between 18.5 to 30.0 (both inclusive), calculated as weight in kg / height 
in m2. 
c) Not having any significant diseases or clinically significant abnormal findings during 
screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG 
and X-ray chest (postero-anterior view) recordings. 
d) Able to understand and comply with the study procedures, in the opinion of the 
principal investigator. 
e) Able to give voluntary written informed consent for participation in the study. 
f) 
In case of female participants: 
• 
Surgically sterilized at least 6 months prior to study participation; 
Or 
If of childbearing potential is willing to use a suitable and effective double barrier 
contraceptive method or intra uterine device during the study. 
And 
• 
Serum pregnancy test must be negative. 
5.2. 
Exclusion criteria  
Participants are excluded from the study if any of the following criteria apply: 
5.2.1. 
Medical Conditions 
a) Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or 
any related drug or any substance. 
b) History or presence of any disease or condition which might compromise the 
haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, 
immunological, dermatological, gastrointestinal or any other body system. 


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c) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp 
or NSAIDs induced urticaria. 
d) History or presence of seizure or psychiatric disorders. 
5.2.2. 
Prior/Concomitant Therapy 
a) Ingestion of a medication (prescribed medication & OTC medication, herbal remedies, 
cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, 
phenobarbital) at any time in 14 days prior to dosing of period I and any vaccine 
(including COVID-19 vaccine) from 14 days prior to dosing of period I. In any such 
case participant selection will be at the discretion of the Principal Investigator. 
5.2.3. 
Prior/Concurrent Clinical Study Experience 
a) Receipt of an intervention or participation in a drug research study within a period of 
90 days prior to the first dose of study intervention **.  
** If intervention is received within 90 days where there is no blood loss except safety 
lab testing, participant can be included considering 10 half-lives duration of 
intervention received. 
5.2.4. 
Diagnostic Assessments 
a) A positive hepatitis screen including hepatitis B surface antigen and/or HCV 
antibodies. 
b) A positive test result for HIV antibody (1 and/or 2). 
c) The presence of clinically significant abnormal laboratory values during screening. 
5.2.5. 
Other Exclusion Criteria 
a) Difficulty in swallowing oral solid dosage form like tablet/capsule. 
b) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption 
of more than 14 standard drinks per week for men and more than 7 standard drinks per 
week for women (a standard drink is defined as 360 ml of beer or 150 ml of wine or 
45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of 
alcohol or alcoholic products within 48 hours prior to dosing of period I. 
c) Smokers, or who have smoked within last 6 months prior to dosing of period I. 
d) Consumption of grapefruits or grapefruit products within a period of 72 hours prior to 
dosing of period I. 
e) Use of any recreational drugs or history of drug addiction or testing positive in pre-
study drug screening. 
f) 
A history of difficulty in donating blood. 
g) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose 
of study intervention. 
h) An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to dosing of 
Period I. In any such case participant selection will be at the discretion of the Principal 
Investigator. 
i) 
Nursing mothers (females). 


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5.3. 
Lifestyle considerations 
5.3.1. 
Meals and dietary restrictions 
• 
All participants will be required to fast overnight for at least 10 hours prior to serving 
of high fat high calorie vegetarian breakfast, which they are required to consume 
completely within 30 minutes of serving the same. The kilo calories and fat content 
derived from the vegetarian meal menu used in this study is approximately 937.66 and 
540 kcal respectively, which is comparable to the non-vegetarian high fat high calorie 
meal menu as recommended by USFDA (Section 10.7). Lunch will be provided 
5 hours after dose administration in each period.  
The dietician/trained study person should weigh the leftover food and calculate the 
calories if the participant has not consumed the high fat high calorie vegetarian 
breakfast completely. 
A standardize meal will be served to the participants at appropriate times during their 
stay in the clinical facility. The contents of the meals served during each period at 
various time points will be identical. The participants will receive lunch at least 5 hours 
after dosing in each period and further meals will be served at appropriate intervals 
from then on, until checkout in each period. Information on the amount of meal 
consumed and the time taken for consuming the meal will be recorded in the source 
data forms. The actual time of meal distributions will also be recorded.  In case meals 
and blood sample collection coincide, samples will be collected at schedule time only.    
Note:  In case any participant has any adverse event and requires any change in diet, 
it will be done after consultation with the Principal Investigator. It will not be 
considered a protocol deviation. This will however be documented. 
• 
No water (except 240  2 mL given with study intervention administration) will be 
allowed from 1 hour before to 2 hour after dose administration in each period. Prior to 
and thereafter, water will be allowed at all times. 
Note: Non-compliance to above fasting/fed requirements and water restriction will be 
recorded as protocol deviation. 
• 
All participants to abstain from grapefruit, grapefruit products for 72 hours prior to 
intervention administration in period I till last PK sample collection of period IV. 
• 
All participants to abstain from an unusual diet, for whatever reason (e.g. low-sodium), 
for 4 weeks prior to dosing of period I and throughout the their participation in the 
study. 
5.3.2. 
Caffeine, alcohol, and tobacco 
• 
All participants to abstain from any Xanthine containing food or beverages (like tea, 
coffee, chocolates or cola drinks), tobacco, tobacco containing products (Gutkha, 
Pan/Pan masala or any other) for 24 hours prior to intervention administration in each 
period and throughout their stay in the clinical facility in each period. 
• 
All participants to abstain from recreational products, alcohol or alcoholic products 
for 48 hours prior to study intervention administration in period I till last PK sample 
collection of period IV. 


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• 
Smoking for 6 months prior to dosing in period I till the completion of the study is 
prohibited and the participants have to abstain from the same. 
5.3.3. 
Activity 
Postural Restriction 
• 
The study intervention will be administered to participants while in sitting posture. 
• 
Participants will be in sitting or ambulatory posture for the first 4 hours post-dose in 
each period unless medically necessary due to adverse event or procedurally required 
or natural exigency, in such cases it would not be considered as protocol deviation. In 
case of adverse event appropriate position will be given to the participants. 
• 
Thereafter, the participants will be allowed to engage only in normal activities while 
avoiding any strenuous physical activity. 
5.3.4. 
Other restrictions 
Not Applicable 
5.4. 
Screen failures 
Not Applicable 
5.5. 
Criteria for temporarily delaying  
Not Applicable 
6. 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
The definition of study intervention is provided in the table of definitions.  
6.1. 
Study intervention(s) administered 
Table 5 
Study Intervention(s) Administered 
Intervention Label 
 
Test (T) 
Reference (R) 
Intervention Name 
Albendazole tablets IP 
400 mg 
Albendazole 400 mg tablets 
Intervention 
Description 
Solid dosage form 
Solid dosage form  
Type  
Drug 
Drug 
Dose Formulation 
Tablet 
Tablet 
Unit Dose 
Strength(s) 
400 mg 
400 mg 
Dosage Level(s) 
single oral dose of 400 mg 
single oral dose of 400 mg 
Route of 
Administration 
oral 
oral 
Use 
active comparator 
active comparator 
IMP and 
NIMP/AxMP. 
Study intervention 
Study intervention 
Sourcing 
Provided by the sponsor  
Provided by the sponsor 
Packaging and 
Labeling 
Study intervention will be 
provided in container. 
Each container will be 
Study intervention will be 
provided in container. Each 
container will be labeled as 


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labeled as required per 
country requirement. 
required per country 
requirement. 
 
While great care is taken to ensure comparability between the 2 tablets, minor differences 
exist (Table 6).  
Table 6 
Differences between Test and Reference tablets 
Parameters 
Test 
Reference 
Conclusion 
Weight target 
1026 mg 
1026.20 mg  
Very Slight Difference in 
Target Weight  
Weight action 
limit 
984.96 - 1067.04 
mg (1026 mg 
±4%) 
974.89 to 1077.51 
mg ((1026 mg 
±5%) 
Action limit of Reference 
is 5% while that of Test is 
4% 
Weight 
operating limit 
995.22 – 1056.78 
mg (1026 mg 
±3%) 
1021.07 to 1031.33 
mg (1026 mg 
±0.5%) 
Operating limit of 
Reference is 0.5% while 
that of Test is 3 % 
Hardness 
108 N - 210 N 
(11.0 to 21.4 
Kg/cm2) 
≥ 110 N 
Target 140 N 
(131-153 N) 
Lower Hardness Limit of 
Test is 108 N while for 
Reference is 110 N. 
Thickness 
6.70 to 7.30 mm 
6.65 to 7.10 mm 
Thickness Limits of Test 
is wider than that of 
Reference 
 
It is the expectation that these differences will not affect absorption kinetics or bioavailability to 
any significant degree. 
6.2. 
Preparation, handling, storage, and accountability 
• 
The sponsor shall supply adequate number of dosage units of study intervention for 
dose administration and for retention purpose. The received study interventions will 
be verified for the sealed condition of packs and adequacy of label (i.e. product name, 
strength, number of dosage units, manufacturer, manufactured date (if available), lot 
number or batch number, expiry date/retest date, study number, investigator and 
storage condition). 
• 
The investigator or designee must confirm appropriate conditions (e.g., temperature) 
have been maintained during transit for all study intervention received, and any 
discrepancies are reported and resolved before use of the study intervention. 


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• 
Only participants enrolled in the study may receive study intervention, and only 
authorized clinical site staff i.e. The Pharmacy custodian or their designated study 
personnel will receive the study interventions with COA. The study interventions will 
be transferred to the pharmacy, after labelling it for project number (as applicable), 
product type, quantity and date of receipt, batch number or lot number, manufacturing 
date, expiry date/retest date, for clinical study use only & storage conditions. 
• 
All study intervention must be stored in a secure, environmentally controlled, and 
monitored (manual or automated) area in accordance with the labeled storage 
conditions with access limited to the authorized site staff. 
• 
Note: Information related to manufactured by/for, marketed/distributed by, marketing 
authorization holder etc. are based on details provided by the sponsor and/or available 
literature at the time of protocol development. Exact details will be captured in the 
study interventions receipt and accountability form by the pharmacy while receiving 
the study interventions. The same details can be used in the clinical study report for 
accuracy and compliance purpose. 
• 
The Pharmacy Custodian and Project Coordinator or their designated study personnel 
will dispense the required units of study interventions prior to each period. Two units 
of study interventions (One test study intervention and one reference study 
intervention) will be dispensed in addition to the required number and labelled 
accordingly in each period. These will be used in any situation such as dropping the 
study intervention’s etc. The remaining units of study interventions will be kept in 
their original containers. 
• 
The doses intended for administration to the participants will be transferred to the 
drug-dispensing containers as per randomization schedule and properly labelled for 
the intervention with strength, dose, product type, project number, participant number, 
period, ‘For Clinical Trial Use Only’, Lambda Therapeutic Research Ltd.   
• 
The personnel involved in dispensing and verification of dispensed study interventions 
will be accountable for ensuring compliance to randomization schedule.  
• 
The investigator, the pharmacy custodian/designate is responsible for study 
intervention accountability, reconciliation, and record maintenance (i.e., receipt, 
reconciliation, and final disposition records). 
• 
Unused study interventions that have not been dispensed will be retained in their 
original containers. Any product that had been dispensed but not used (e.g. due to the 
participant being unwell or dropping out from the trial etc.) will be labelled as ‘Not 
For Use’ and returned to the pharmacy and will be retained along with the other study 
interventions of its type. 
• 
Retention samples: Samples of the study intervention in the original container should 
be retained for possible confirmatory testing in the future in compliance with the 
applicable national requirements or international recommendations, as appropriate. 
Dispensed study intervention that were not administered should also be retained. All 
the study interventions not used during the study will be accounted for and all unused 
supplies will be retained for 5 years after study completion. Once the above-mentioned 
time period is over, samples will be returned to the sponsor or as per sponsor’s request 
necessary action will be taken. 


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6.3. 
Assignment to study intervention 
Randomization 
The order of receiving test (T) and reference (R) intervention for each participant during 
all the periods of the study will be determined according to a randomization schedule by 
Lambda. The randomization schedule will be generated using SAS® Version 9.4 or higher 
(SAS Institute Inc., USA) by a biostatistician.  
The sequence of administration of intervention i.e. “TRTR” or “RTRT” to the participants 
will be determined according to the randomization schedule. (Note: T = Test study 
intervention and R = Reference study intervention). Equal allocation of participants in each 
sequence is planned. 
The personnel involved in dispensing of study intervention and verification of dispensed 
study interventions will be accountable for ensuring compliance to randomization 
schedule. 
6.4. 
Blinding, masking 
Not Applicable 
6.5. 
Study intervention compliance 
Dosing activity will be followed by thorough mouth check with torch & disposable spatula 
by the trained study personnel immediately after study intervention administration to 
access compliance to dosing. The time of administration of the study intervention will be 
the time at which the participant completes drinking 240 ± 2 mL of water and that will be 
captured in the respective source data forms. 
6.6. 
Dose modification 
Not Applicable 
6.7. 
Continued access to study intervention after the end of the study 
There is no intervention following the end of the study.  
6.8. 
Treatment of overdose 
Not Applicable.  
6.9. 
Prior and concomitant therapy 
No drug (prescribed & OTC medication including herbal remedies, cimetidine, 
praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) other 
than the intervention shall be consumed by the participants from 14 days prior to dosing of 
period I till completion of study and any vaccine (including COVID-19 vaccine) within 14 
days prior to dosing of each period. If drug therapy other than that specified in the protocol 
is required prior to dosing or during the study or in the wash-out period, decisions shall be 
taken by the Principal Investigator to continue or discontinue the Participants based on the 


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following: 
a) 
The pharmacology and pharmacokinetic of the non-study medicine. 
b) 
The likelihood of a drug–drug interaction, thereby affecting the pharmacokinetic 
comparison of study intervention. 
c) 
The time and duration of administration of the non-study medicine. 
All such instances will be recorded and reported in the final report. 
Note: Any concomitant medication administered during the course of the trial will be 
documented appropriately in the source data forms. 
6.9.1. 
Rescue medicine 
Not Applicable. 
7. 
DISCONTINUATION 
OF 
STUDY 
INTERVENTION 
AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of study intervention 
Not Applicable 
7.1.1. 
Liver chemistry stopping criteria 
Discontinuation of study intervention in the best interest of the participant for abnormal 
liver tests at the investigator discretion, when liver parameter falls outside the pre-defined 
clinically acceptable values. Acceptable limits are defined in Section 10.6. 
If any participant has clinically significant abnormal liver function analysis, in such case 
participant may be discontinued for specific period at the investigator discretion. The 
decision to continue/discontinue such participants will be based on investigator’s decision 
and it will be appropriately documented in the eCRF.  
7.1.2. 
QTc Stopping criteria 
Not Applicable 
7.1.3. 
Temporary discontinuation 
Not Applicable 
7.1.4. 
Rechallenge 
Not Applicable 


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7.1.4.1. 
Study Intervention Restart or Rechallenge After Liver Stopping Criteria 
Are Met 
Study intervention restart or rechallenge after liver chemistry stopping criteria are met by 
any participant in this study are not allowed. 
7.2. 
Participant discontinuation/withdrawal from the study 
The Principal Investigator may withdraw a participant from a period or from the study for 
any of the following reasons:  
A participant may withdraw from the study at any time at the participant’s own request for 
any reason (or without providing any reason). (Note: If the participant does not wish to be 
withdrawn from particular period only or from the study permanently then participant can 
be allowed to continue their participation in subsequent periods as per investigator’s 
discretion). 
A participant may be withdrawn at any time at the discretion of the investigator for safety 
reasons, any participant found to hide important medical history, violation of this protocol 
(this would include pre-study directions regarding alcohol and drug use, fasting/fed or if 
the participant is non-compliant during the study or uncooperative with study procedures). 
If it is felt in Principal Investigator’s opinion that it is not in the participant’s best interest 
to continue. 
The participant suffers from significant inter-current illness or undergoes surgery during 
the course of the study, or the participant has any significant symptoms or signs during the 
course of the study. 
Note: For any participant who is withdrawn from any period due to emesis (within 4 hours 
post-dose) or any adverse events the decision regarding participant’s continuation for 
subsequent periods will be based on investigator’s discretion. 
Any participant who requires the use of an unacceptable concomitant medication 
(prescribed & OTC medication including herbal remedies, cimetidine, praziquantel, 
dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital). 
Any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of each period. 
In any such case decisions shall be taken by the Principal Investigator to continue or 
discontinue the participant. 
If any participant cross-participates in other drug trial or trial screening. 
Found positive in serum pregnancy test (for female participants). 
Any participant experiences emesis before reported 2 times median Tmax (i.e. 2 x 2hour = 
4hour) after dosing of the study intervention for a particular period, then participant will 
be withdrawn for that period only or from study as per investigator’s discretion. 


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If any participant does not report to facility in any period due to own accord, then they can 
be allowed to continue their participation in subsequent periods as per investigator’s 
discretion. 
Any participant has consumed the high fat high calorie vegetarian breakfast less than 
800 kcal, then participant will be withdrawn from a particular period or from the study as 
per investigator’s discretion. 
Any other justifiable reason, which should be adequately documented. 
All instances of participant who withdraw from the study, including the date and reason 
for withdrawal will be documented and shall be handled as per the in-house procedure. 
Any untoward effect reported by the participant who is withdrawn will be incorporated into 
the final study report. These participants will be followed up for their safety as per in-house 
SOP. 
All data and samples collected up to and including the date of withdrawal of/last contact 
with the participant will be included in the study analyses. If the participant withdraws 
consent for disclosure of future information, the sponsor may retain and continue to use 
any data collected before such a withdrawal of consent. 
7.3. 
Lost to follow-up 
The participant is expected to visit the facility immediately for repeat evaluation/ follow 
up in case of:  
• Any ongoing adverse event or abnormal laboratory parameter identified during End 
of Study visit. 
• 
Any adverse event that may occur after the last intervention administration and 
within the duration of 10 half-lives (t1/2 of the IMP) or duration equivalent to the 
defined wash out period (7 days), whichever is shorter. 
In either of the above 2 scenarios, the participant would be followed up till resolution/ 
stabilization of AE. Participant will be considered lost to follow-up if the participant 
repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. 
In case the participant does not respond even after repeated communications or is not 
accessible, the participant should be considered as lost to follow-up and such cases will be 
handled as per standard operating procedures. The participant is considered to have 
completed the study after the last intervention administration, once the duration of 10 half-
lives (t1/2 of the IMP) or duration equivalent to the defined wash out period, whichever is 
shorter. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
• All participants will undergo physical and clinical screening procedure within 28 days 
prior to the first dose administration. The participant will be selected on the inclusion 
and exclusion criteria mentioned in Section 5.1 and Section 5.2. 


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• 
Study procedures and their timing are summarized in the SoA in Section 1.3 Schedule 
of activities (SoA). Protocol waivers or exemptions are not allowed. 
• 
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
• 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria.  
• 
Laboratory parameters obtained during the process of screening will be evaluated as 
follows:  
i. Out of range values of other hematology and biochemistry parameters and urine 
parameters will be individually evaluated and / or repeated for their clinical 
significance. A participant will be enrolled into the study only if the medically 
qualified reviewer deems the values clinically insignificant or acceptable. 
ii. All immunology parameters are required to be negative. 
iii. Serum Pregnancy test for females will be negative 
(Note: In case if any extra tests are analyzed, it will not have any impact on the trial 
if the parameters and the values are clinically insignificant.) 
• 
Include the maximum amount of blood collected from each participant over the 
duration of the study and if any repeat or unscheduled samples may be taken, as 
appropriate. 
• Single oral dose of 1 tablet of either Test study intervention or Reference study 
intervention (each containing 400 mg of albendazole) will be administered to each 
participant in each period. 
8.1. 
Administrative procedures 
8.1.1. 
Collection of demographic data 
Record demographic data such as date of birth, sex, race, age, height, weight, BMI and 
ethnicity in the MSR.  
Collection of sex, race and ethnicity data is necessary to assess and monitor the diversity 
of the trial participants, and to determine if the trial participants are truly representative of 
the impacted population. 
8.1.2. 
Medical/vaccination history 
Current medication (prescribed medication & OTC medication, herbal remedies, 
cimetidine, 
praziquantel, 
dexamethasone, 
ritonavir, 
phenytoin, 
carbamazepine, 
phenobarbital) and usage of any concomitant therapy or any ingestion of medicine in the 
previous 14 days prior to dosing of period I and any vaccine (including COVID-19 vaccine) 
from 14 days prior to dosing of period I. 


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8.2. 
Pharmacokinetic assessments 
Planned timepoints for PK assessments: 
A total of 22 blood samples, each of 3 mL will be collected from each participant in each 
period. 
The venous blood samples for determination of albendazole and albendazole sulfoxide will 
be drawn at pre-dose and at 20 min, 40 min, 60 min, 80 min,  100 min, 120 min (2h00min), 
2.33 (2h20min), 2.67 (2h40min), 3.00 (3h00min), 3.33 (3h20min), 3.67 (3h40min), 4.00 
(4h00min), 4.50 (4h30min), 5.00 (5h00min), 6.00 (6h00min), 8.00 (8h00min), 10.00 
(10h00min), 12.00 (12h00min), 14.00 (14h00min), 18.00 (18h00min) and 24.00 hours 
(24h00min) post dose in each period. 
8.3. 
Safety assessments 
Planned timepoints for all safety assessments are provided in the SoA. 
8.3.1. 
Physical/Clinical examination and clinical safety measures 
• 
A physician will be available within the clinical facility whenever the participants are 
housed (from check in to checkout in each period). A consultant physician will be 
always available on call during the study period. 
• 
Clinical examination of the participants including recording of vital signs (blood 
pressure, respiratory rate and radial pulse) and body temperature will be done at 
screening, after check-in, before check-out in each period.  
Note: Clinical examination before checkout may be started 120 minutes prior to the 
schedule time of checkout of each participant. 
• 
Participants should meet the criteria for enrolment in the study. 
• 
Participants will be questioned for well-being at the time of clinical examinations and 
during recording of vital signs examination in each period. 
• 
Participants will be instructed not to participate in other clinical trial or donate blood 
anywhere else during the study. 
• 
Drug of abuse in urine and Breath alcohol test will be performed on check-in of each 
period. 
• 
Chest X-ray (within the last 6 months) (postero-anterior view) will be carried out at 
the time of screening. 
• 
Participants will be instructed not to drive or operate machines during the entire study 
as the study drug may cause dizziness. 
8.3.2. 
Vital signs 
• 
Vitals (sitting blood pressure and radial pulse) will be recorded at pre-dose (within 60 
minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period. 


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Note: All post-dose vitals will be performed within ± 40 minutes of the scheduled 
time. 
8.3.3. 
Electrocardiograms 
• 
12-lead ECG will be carried out at the time of screening as outlined in the SoA (see 
Section 1.3).  
8.3.4. 
Clinical safety laboratory tests 
• 
See Section 10.2 for the list of clinical laboratory tests to be performed and the SoA 
(Section 1.3). 
• 
Serology tests (HIV AB (1 & 2), Anti HCV and HBsAg) will be performed at the time 
of screening. 
• 
Urine parameters will be performed at the time of screening. 
• 
Laboratory assessment for hematology and biochemistry will be performed at the time 
of screening. 
• 
Laboratory assessment for hematology and biochemistry (except random glucose, 
sodium, potassium, chloride, alkaline phosphatase) will be performed at the end of the 
study (at the time of check-out of period IV). 
• 
Laboratory assessment for liver function test (SGPT, SGOP and total bilirubin) will 
be performed prior to check-in of period II, III and IV. 
• 
The investigator must review the laboratory results, document this review, and record 
any clinically significant changes occurring during the study as an AE. The laboratory 
results must be retained with source documents.  
• 
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study should be repeated until the values return to normal or 
baseline or are no longer considered clinically significant by the investigator or 
medical monitor. 
o 
In the absence of a diagnosis, abnormal laboratory findings assessments  or 
other abnormal results the investigator considers clinically significant will be 
recorded as an AE or SAE, if they meet the definition of an AE or SAE (refer 
to Section 10.3.1 and Section 10.3.2).  
o 
If clinically significant values do not return to normal/baseline within a 
period of time judged reasonable by the investigator, the etiology should be 
identified, and the sponsor notified. 
o 
If laboratory values from non-protocol-specified laboratory tests performed 
at the institution’s local laboratory require a change in participant 
management or are considered clinically significant by the investigator (e.g, 
SAE or AE), then the results must be recorded. 


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8.3.5. 
Pregnancy testing 
• 
Serum Pregnancy test for female participants will be done at the time of screening, 
prior to check-in of each period and at the end of the study (at the time of check-out 
of period IV). Pregnancy testing must be done even if the participant is menstruating 
at the time of the study visit. The study intervention may only be administered if the 
pregnancy test is negative. 
• 
For female participants history of menstruation and use of contraceptive methods will 
be evaluated by trained study physician at the time of screening.  
• 
Refer to Section 8.4.5 for the information on study continuation for participants who 
become pregnant during the study. 
8.3.6. 
Safety Measures for Volunteers during Covid-19 pandemic 
Regulatory authorities have recognized that COVID-19 pandemic may impact the conduct 
of clinical trials of medical products. Thus, in order to assure safety of trial participants, 
and to ensure compliance with protocol and regulatory guidance and to minimize risk to 
trial integrity during COVID-19 pandemic, certain additional safety measures shall be 
taken into consideration. These safety measures are described in the Safety Policy for 
COVID-19 Pandemic situation (Document Number: SP/IND/001 or as applicable). The 
participants will be informed about additional safety measures through respective 
Annexure of Safety Policy and consenting for the same will be taken. 
8.3.7. 
Study stopping rules/holding rules, safety monitoring AND/OR 
Committee 
Not Applicable 
8.4. 
Adverse Events (AEs) serious adverse events (SAEs), and other safety 
reporting 
For definitions relating to safety information see Section 10.3 
The investigator and any qualified designees are responsible for detecting, documenting, 
and recording events that meet the definition of an AE or SAE and other safety information 
and remain responsible for following up all AEs that are serious, considered related to the 
study intervention or study procedures, or that caused the participant to discontinue the 
study (see Section 7). This includes events reported by the participant (or, when appropriate, 
or the participant’s legally authorized representative). 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.3. 


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8.4.1. 
Time period and frequency for collecting AE, SAE, and other safety 
information 
All AEs and SAEs will be collected from the signing of the informed consent form (ICF) 
until the end of period IV at the time points specified in the SoA.  
SAEs assessed as related to study participation (e.g., study intervention, protocol-
mandated procedures, invasive tests, or change in existing therapy) will be recorded from 
the time a participant consents to participate in the study. 
All adverse events, including both observed or voluntarily reported problems; complaints, 
signs or symptoms occurring after the first dose administration shall be recorded on the 
relevant page "Adverse Event/Medical Event Record Form" of eCRF irrespective of its 
association with the ongoing study medication. Prior to first dose administration in each 
participant, the event will be considered as a medical event and the aforementioned form 
will be completed by encircling “Medical Event” in the title. 
All SAEs will be recorded and reported to the sponsor or designee immediately and under 
no circumstance should this exceed 24 hours of occurrence as indicated in Section 10.3. 
The investigator will submit any updated SAE data to the sponsor as Follow up report 
within 24 hours of awareness.  
A poststudy AE/SAE is defined as any event that occurs outside of the AE/SAE reporting 
period defined in Section [8.4.1]. 
Investigators are not obligated to actively seek information on AEs or SAEs after 
conclusion of the study participation. However, if the investigator learns of any SAE, 
including a death, after a participant has been discharged from the study, the investigator 
must record it in the medical records. If the investigator considers the event to be 
reasonably related to the study intervention or study participation, the investigator must 
promptly notify the sponsor. 
8.4.2. 
Method of detecting AEs and SAEs  
Care will be taken not to introduce bias when detecting AEs and SAEs. Open-ended and 
nonleading verbal questioning of the participant/LAR(s) is the preferred method to inquire 
about AE occurrences. 
8.4.3. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow up with 
each participant at subsequent visits/contacts. All SAEs will be followed up until resolution, 
stabilization, the event is otherwise explained, or the participant is lost to follow-up (as 
defined in Section 7.3).  


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8.4.4. 
Regulatory reporting requirements for SAEs  
• 
Prompt notification by the investigator to the sponsor of an SAE is essential so that 
legal obligations and ethical responsibilities toward the safety of participants and the 
safety of a study intervention under clinical investigation are met. See [Section 8.4.1] 
for reporting timeframes. 
• 
For SAEs, the investigator must always provide an assessment of causality at the time 
of the initial report, as defined in the Section 8.4. 
• 
An investigator who receives an safety report describing an SAE or other specific 
safety information (e.g., summary or listing of SAEs) from the sponsor will review 
and then file it along with the package insert and will notify the Institutional Review 
Board (IRB) / Institutional Ethics Committee (IEC), if appropriate according to local 
requirements. 


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Table 7 
Timeframes for submitting SAE, pregnancy and other events reports to GSK, Ethics Committee and CDSCO   
Type of 
event 
Responsible 
Initial reports 
Follow-up of relevant information on a previous report 
Time 
frame 
Documents 
Time 
frame 
Documents 
SAEs 
Investigato
r 
24 hours of 
SAE 
Occurence* 
‡ 
Completed Table 5 format of the New 
Drugs & Clinical Trial Rules, 2019 to 
be sent to CDSCO via SUGAM portal 
and to GSK PV mailbox: 
india.pharmacovigilance@gsk.com and 
to the Chairman of the respective Ethics 
Committee 
24 hours of 
awareness 
of follow 
up 
informatio
n * 
Upload the Follow up Table 5 in 
SUGAM (via eVartalap) and send to the 
Sponsor (GSK PV mailbox) and EC 


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Type of 
event 
Responsible 
Initial reports 
Follow-up of relevant information on a previous report 
Time 
frame 
Documents 
Time 
frame 
Documents 
SAEs 
Investigato
r 
Within 14 
calendar 
days of 
SAE 
occurrenc
e 
Due Analysis Report (Investigator 
Causality Assessment) to be submitted 
to CDSCO via SUGAM and notify 
Head of Institution (HOI) and EC via 
email/letter and notify GSK via 
sending email to PV mailbox 
mentioned above. 
In case of any delay, the reason for 
delay will need to be provided in 
SUGAM and the Sponsor. 
Note: In case of technical issue of 
SUGAM portal, notify to CDSCO via 
email dci@nic.in 
Within 14 
calendar 
days of 
SAE 
awareness 
Update the Due Analysis report via 
SUGAM and notify HOI and EC via 
email/letter and notify GSK via 
sending email to PV mailbox 
mentioned above. 
Note: In case of technical issue of 
SUGAM portal, notify to CDSCO via 
email dci@nic.in 
 
Pregnancie
s  
Investigato
r 
Within 24 
hours of 
learning 
Pregnancy Notification Form to be sent 
to 
WW.GSKAEReportingAPAC@gsk.co
Within 24 
hours of 
awareness 
 Pregnancy Follow up Notification 
Form to be sent to 
WW.GSKAEReportingAPAC@gsk.co


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Type of 
event 
Responsible 
Initial reports 
Follow-up of relevant information on a previous report 
Time 
frame 
Documents 
Time 
frame 
Documents 
of 
pregnancy 
m with a copy to 
india.pharmacovigilance@gsk.com 
* 
m with a copy to 
india.pharmacovigilance@gsk.com 
* Timeframe allowed after receipt or awareness of the information by the investigator/site staff. 
‡AEs Report will be dated and signed by the investigator (or designee).  For each SAE, the investigator(s) must document in the medical notes that they have reviewed 
the SAE and have provided an assessment of causality. 
CDSCO=Central Drugs Standard Control Organization, , EC= Ethics Committee, PV= pharmacovigilance, SAE= serious adverse event. 


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8.4.5. 
Pregnancy 
Female participants who become pregnant after the first study intervention dose must not 
receive subsequent doses of the study intervention and will be withdrawn from the study 
but may continue other study procedures at the discretion of the investigator. 
Handling and reporting of pregnancy during the clinical study will be done as per in-house 
SOP. 
8.4.6. 
Cardiovascular (CV) and death events 
CV and death events will be handled as per Section 8.4 and Section 10.3. 
8.4.7. 
Disease-related events and/or disease-related outcomes not qualifying as 
AEs or SAEs 
Not Applicable 
8.4.8. 
Contact information for reporting SAEs, Pregnancies 
Table 8 
Contact information for reporting SAEs, pregnancies  
Study contact for questions regarding 
SAEs and pregnancies, Contact 
CRO/GSK’s local and/or medical contacts 
Sponsor SAE/Pregnancy reporting 
Contact Information: Email: 
india.pharmacovigilance@gsk.com 
Phone: +91-8657549542 
 
 
8.5. 
Pharmacokinetics 
Assessment of Pharmacokinetic Parameters: 
Pharmacokinetic Analysis 
Pharmacokinetic analysis will be performed on the available concentration data of all the 
participants. 
Criteria for exclusion of pharmacokinetic parameters of particular participants from 
statistical analysis will be as below: 
Participants who were discontinued/withdrawn and do not have evaluable data for at least 
1 treatment and 1 reference drug period will be excluded. 
Three consecutive missing (M) / Non-Reportable (NR) samples in elimination phase may 
significantly influence the AUC0-t and elimination phase dependent parameters (AUC0-∞, 
AUC0-t, t1/2, λz, AUC_%Extrap_obs). Inclusion of such parameters in the statistical 
analysis may mislead the final outcome. Hence, AUC(0-t) and elimination phase dependent 
parameters (AUC0-∞, AUC(0-t), t1/2, λz, AUC_%Extrap_obs) will be excluded. 


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The concentration–time profiles of subjects who exhibit pre-dose concentrations higher 
than 5% of the corresponding Cmax of that period will be excluded from the statistical 
analysis [Note: a statistical sensitivity analysis including the same will be provided for 
information purpose]. 
Participants without measurable concentrations or who have only very low plasma 
concentrations relative to that of the product in question, will be excluded from the 
pharmacokinetic and statistical analyses. A participant is considered to have very low 
plasma concentrations if their AUC is less than 5% of the geometric mean AUC of the 
product in question, calculated without inclusion of data from the outlying participant 
[Note: statistical analysis with including the same will be provided for information 
purpose]. 
Pharmacokinetic Parameters 
The following pharmacokinetic parameters will be computed for albendazole and 
albendazole sulfoxide using non-compartmental model of Phoenix® WinNonlin® Version 
8.3 or higher (Certara L.P.) for each period: 
Primary PK Parameters: 
Cmax 
: Maximum measured plasma concentration. 
AUC(0-t) 
: Area under the plasma concentration versus time curve from time 
zero to the last measurable concentration as calculated by linear 
trapezoidal method. 
Secondary PK Parameters 
AUC0- 
: Area under the plasma concentration versus time curve from 
time zero to time infinity. Where AUC0- = AUC(0-t) + Ct/z, 
Ct is the last measurable concentration and z is the terminal 
rate constant. 
Tmax 
: Time of the maximum measured plasma concentration.  
z 
: First order rate constant associated with the terminal (log-linear) 
portion of the curve. This is estimated via linear regression of 
time vs. log concentration. 
This parameter will be calculated by linear least squares 
regression analysis using at least last 3 non-zero plasma 
concentration values. 
t1/2 
: The terminal half-life will be calculated as 0.693/z. 
AUC_%Extrap_obs : The residual area in percentage will be determined by the 
formula, [(AUC0- - AUC0-t)/AUC0-] x 100. 
For all the above computations, actual time points of the sample collection will be used. 
Non-quantifiable (NQ) data, such as concentrations below the quantification limit may be 
excluded or omitted, depending on where they are located in time, see Section 9.4.2.5. 
No value of λz, AUC0-, AUC_%Extrap_obs and t1/2 will be reported for cases that do 
not exhibit a terminal log-linear phase in the concentration versus time profile. 
 


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Procedure of blood sampling and its collection 
Blood samples will be collected through an indwelling intravenous cannula (Venflon) 
placed in a forearm vein of the participants. The pre-dose blood sample will be collected 
within a period of 60 minutes before dosing. Post dose in-house blood samples will be 
collected within ± 2 minutes from scheduled time. The actual time of collection of each 
blood sample will be recorded immediately after blood collection. For precaution purpose, 
the blood samples will be kept in an ice-cold water bath during collection. 
Cannula will be removed after collection of 24.000 hours blood sample.  
All Blood samples not collected within this time frame from scheduled time will be 
documented as sampling deviations. 
Intravenous indwelling cannula will be kept in situ as long as possible by injecting 0.5 mL 
of normal saline solution to maintain the cannula patent (to prevent cannula from clogging) 
for collection of all the blood samples up to 24.000 hours post dose in each period. In such 
cases blood samples will be collected after discarding the first 0.5 mL of normal saline 
containing blood from the tubing. The blood samples will be collected and transferred into 
pre-labelled (mentioning Project number, Participant number, Period, Sample ID No./ Bar 
code ID and Sampling time point) sample collection tube containing K2EDTA as an 
anticoagulant. Immediately after each tube of blood is drawn, it should be inverted gently 
several times to ensure the mixing of tube contents (i.e., anticoagulant). The sample 
collection tubes will be placed in an ice-cold water bath until centrifugation for precaution 
purpose. 
Alternatively, if the cannula is blocked or there is difficulty in withdrawing blood through 
the cannula, blood samples may be withdrawn by a fresh vein puncture using a disposable 
sterile syringe and a needle at each time of collection. Blood sample for serum pregnancy 
test for females prior to check in of each period and blood sample for laboratory assessment 
of liver function test prior to check-in of period II, III, IV will be collected through a fresh 
vein puncture.  
For each participant, the total volume of blood loss should not be exceeding 334 mL for 
male participants and 342 mL for female participants calculated as follows: 
 
 
 
Male 
Participants 
Female 
Participants 
+ Blood volume for the samples for 4 periods (84 post-
dose samples of 3 mL each and 4 pre-dose samples 
of 3 mL each). 
: 
264 mL 
264 mL 
+ Discarded normal saline blood for 4 periods (88 
samples of 0.5 ml each) 
: 
44 mL 
44 mL 
+ Blood withdrawn for screening prior to study 
: 
Up to 11 
mL 
Up to 11 
mL 


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Male 
Participants 
Female 
Participants 
+ Serum β-HCG tests (On check-in day of each period 
for female participants 
: 
--- 
8 mL 
+ Laboratory assessment for liver function test prior to 
check-in of period II, III and IV 
: 
6 mL 
6 mL 
+ Blood withdrawn for post-study safety assessment 
: 
Up to 9 mL 
Up to 9 mL 
Total Blood Loss for each participant 
: 
334 mL 
342 mL 
Note: In addition to above up to additional of 20.0 mL blood sample will be collected if 
required, for hemolyzed sample, clotted sample, sample loss, any safety assessment 
deemed necessary at screening, prior to check-in of any period & during the study, required 
as per method requirement or any other reason. 
Sampling Schedule 
A total of 22 blood samples each of 3 mL, will be collected from each participant in each 
period. 
The venous blood samples will be withdrawn at the following times. All actual sample 
times will be recorded in addition to their planned time. 
 
Table 9 
PK sampling schedule 
Day 
Time points 
(Hours) 
Proposed clock 
time  
 
Blood 
volume 
(mL) 
Analytes to measure 
Albendazole Albendazole 
Sulfoxide  
1 
 
Pre-dose 
(0.00) 
Within 60 minutes 
prior to dosing 
3.0 mL 
√ 
√ 
0.33 
0h20min 
3.0 mL 
√ 
√ 
0.67 
0h40min 
3.0 mL 
√ 
√ 
1.00 
1h00min 
3.0 mL 
√ 
√ 
1.33 
1h20min 
3.0 mL 
√ 
√ 
1.67 
1h40min 
3.0 mL 
√ 
√ 
2.00 
2h00min 
3.0 mL 
√ 
√ 
2.33 
2h20min 
3.0 mL 
√ 
√ 
2.67 
2h40min 
3.0 mL 
√ 
√ 


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Day 
Time points 
(Hours) 
Proposed clock 
time  
 
Blood 
volume 
(mL) 
Analytes to measure 
Albendazole Albendazole 
Sulfoxide  
3.00 
3h00min 
3.0 mL 
√ 
√ 
3.33 
3h20min 
3.0 mL 
√ 
√ 
3.67 
3h40min 
3.0 mL 
√ 
√ 
4.00 
4h00min 
3.0 mL 
√ 
√ 
4.50 
4h30min 
3.0 mL 
√ 
√ 
5.00 
5h00min 
3.0 mL 
√ 
√ 
6.00 
6h00min 
3.0 mL 
√ 
√ 
8.00 
8h00min 
3.0 mL 
√ 
√ 
10.00 
10h00min 
3.0 mL 
√ 
√ 
12.00 
12h00min 
3.0 mL 
√ 
√ 
14.00 
14h00min 
3.0 mL 
√ 
√ 
2 
18.00 
18h00min 
3.0 mL 
√ 
√ 
24.00 
24h00min 
3.0 mL 
√ 
√ 
Day 1: Day of study intervention administration in each period.  
Day 2: Subsequent day after study intervention administration in each period. 
Sample Analysis for Pharmacokinetic / Safety analysis 
Plasma Separation 
The blood samples will be centrifuged at 3000  100 rcf for 5 minutes below 10 °C to 
separate plasma. For precaution purpose the blood samples will be kept in an ice-cold water 
bath before centrifugation and during separation.  
The separated plasma will be transferred to pre-labelled polypropylene tube in 2 aliquots 
(around 0.5 mL in first aliquot and rest of the volume in second aliquot). 
All the samples will be stored upright in a box containing adequate amount of dry ice or in 
a freezer at a temperature -55 °C or below at clinical site until transferred to bio-analytical 
site. 
The samples will be transferred from clinical site to bio-analytical site by keeping them in 
a box containing adequate amount of dry ice and stored in a bio-analytical freezer at -55  °C 
or below until completion of analysis at Lambda Therapeutic Research Ltd., Ahmedabad.  
Initially first aliquot samples will be transferred to bio-analytical site and once the samples 
received at bio-analytical site, the second aliquot will be transferred from clinical site 
separately. 
 
Bioanalytical Procedures 
Plasma samples of participants will be assayed for albendazole and albendazole sulfoxide 


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using single liquid-chromatography with tandem mass spectrometry (LC-MS/MS) method, 
which is validated according to the international guidelines. 
Bioanalytical study plan will be prepared before study sample analysis. 
The analysis of participant samples will be done using a calibration curve with quality 
control samples. The details for the preparation of the calibration curve and quality control 
samples, analytical run organization and the analytical run acceptance criteria as discussed 
in the respective in-house SOP will be followed during analysis. 
The analysts will not have access to the randomization schedule.  
All the collected samples will be analyzed except if any participant dropped out after 
dosing and no post dose samples are collected then pre-dose sample of that period of such 
participant would not be analyzed. 
The criteria for repeat analysis, as defined in the respective in-house SOP, will be followed. 
Incurred sample reproducibility will be performed to confirm the reliability of the study 
data. Sample selection will be based on the below table and the procedure and acceptance 
of the results will be as per the in-house SOP. The results will be presented in the 
bioanalytical report. 
Sample Size 
No. of ISR samples 
Total sample size up to 
1000 sample 
: 10 % of total samples 
Total 
sample 
size 
>1000 sample 
: 100 samples (10 % of 1000 samples) + 5 % of (Total samples 
– 1000 samples)  
Any missing samples will be reported as `M’ and any non-reportable concentration values 
which may arise due to insufficient quantity for repeat analysis or due to any other reason 
as per in-house SOP will be reported as ‘NR’.   
Primary (first) aliquot used for study sample analysis will be discarded after completion of 
analysis. 
8.6. 
Pharmacodynamics 
Not Applicable 
8.7. 
Genetics 
Not Applicable  
8.8. 
Biomarkers 
Not Applicable 
8.9. 
Immunogenicity assessments 
Not Applicable 


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9. 
STATISTICAL CONSIDERATIONS 
A SAP will be prepared which will include a more technical and detailed description of 
the statistical analyses described in this section. This section is a summary of the planned 
statistical analyses of the most important endpoints including primary and key secondary 
endpoints. 
9.1. 
Statistical Hypotheses  
According to WHO product specific guidance (Notes on the Design of Bioequivalence 
Study: Albendazole; 29 March 2021), albendazole pharmacokinetics in the fed state is 
highly variable (up to 68% for Cmax and 62% for AUC). Therefore, this study was 
designed as a replicate cross-over study, to estimate variability more accurately and, if 
indicated, to widen the acceptance range for Cmax and AUC(0-t) (World Health 
Organisation, 2021). Considering the same, full replicate study has been planned in line 
with WHO product specific guidance document and reference-scaled average 
bioequivalence approach will be used for hypothesis testing.  
 
 
The null hypothesis to be tested is: 
 
𝐻0:
(μ𝑇−𝜇𝑅)
2
𝜎𝑊𝑅
2
≥ 𝜃  
 
Versus alternative hypothesis 
 
𝐻1:
(μ𝑇−𝜇𝑅)
2
𝜎𝑊𝑅
2
<  𝜃  
 
Where: μ𝑇 and 𝜇𝑅 are the means of ln-transformed PK parameters (Cmax and/or AUC) 
obtained from the BE study for the test and reference products, respectively.  
𝜎𝑊𝑅 is the within-subject standard deviation of the log-transformed values of PK 
parameter of the reference study intervention. 
Testing will be performed at a level of 0.05 and 𝜃 is the scaled average BE limit. 
The test drug must pass for primary endpoint PK parameters (Cmax and AUC(0-t)) to 
demonstrate BE to the reference drug. Let σW 0 be the regulatory constant (based on 0.80-
1.25 geometric mean ratio restriction criteria) and assumed to be 0.294.  
a. The 90% confidence interval of GMR of T/R must be contained within [U, L] = exp 
[±k·sWR], which is scale acceptance limit based on k(θS),  
Where k = ln(1.25)/σW 0 which is approx. 0.760 
U is the upper limit of the acceptance range, L is the lower limit of the acceptance 
range, 


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sWR is the within-subject standard deviation of the log-transformed values of PK 
parameter of the reference study intervention  
b. Point estimate of GMR of T/R should be between 80.00 –125.00%. 
For the parameters Cmax and AUC(0-t), if the intra-subject CVW of for the reference study 
intervention is less than or equal to 0.30 upon trial completion for any of these treatment 
group, conventional average BE approach with TOST procedure with α=0.05 for each one-
sided test will be used to test 0.8 ≤ GMR ≤ 1.25. This is equivalent to requiring that a 90% 
interval for the true ratio of test to reference geometric means falls entirely within the range 
of 80.00 to 125.00%. If the intra-subject coefficient of variation (CVW) of for the reference 
study intervention is greater than 0.30 upon trial completion, a reference-scaled average 
bioequivalence approach will be used5.  
If the intra-subject variability for Cmax and AUC(0-t) following replicate administrations 
of the comparator product is > 30%. If this is the case the acceptance criteria for Cmax and 
AUC(0-t) will be widened to a maximum of 69.84–143.19%. 
9.2. 
Multiplicity Adjustment 
No multiplicity adjustment is required for this bioequivalence study. 
9.3. 
Analysis sets 
 
Analysis Sets  
Description  
Randomized  
All participants assigned to study treatment  
Safety set  
The safety set will include all randomized participants who receive at 
least 1 dose of study medication. The safety population will be used for 
all analyses of safety data.  
PK set  
All participants in the Safety set who had at least 1 measurable PK 
assessment (for the purpose of the PK analysis, only those 
participants in this dataset who have evaluable data for one test and 
one reference period will be used). 
9.4. 
Statistical Analysis 
9.4.1. 
General considerations 
The pharmacokinetic parameters will be analyzed to evaluate the differences between the 
test and reference study interventions by applying referenced scaled average 
bioequivalence approach.  
 
All the statistical analysis will be performed using SAS® Version 9.4 or higher (SAS 
Institute Inc., USA). 
The participants having pharmacokinetic parameters available for 2 reference treatments 
will be included for calculation of intra-subject variability of reference study intervention. 
Descriptive statistics & average bioequivalence analysis will be performed on the 


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participants having pharmacokinetic parameters available for at least on test and 1 
reference arm. 
 
9.4.2. 
Primary Endpoint(s)/Estimand(s) Analysis 
9.4.2.1. 
Descriptive statistics 
Statistical analysis for primary endpoints will include descriptive statistics for the 
following pharmacokinetic parameters:  
 
Cmax and AUC(0-t) 
 
Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, geometric mean, 
95% CI of geometric mean, SD, median, minimum and maximum) will be presented for 
primary PK parameters. 
Average values of Test Study Intervention-T and Reference Study Intervention-R for PK 
parameters for each participant will be calculated and reported. Descriptive statistics will 
be calculated and reported for the same data.  
Individual values of PK parameters for Test Study Intervention-T (first administration), 
Test Study Intervention-T (second administration), Reference Study Intervention-R (first 
administration) and Reference Study Intervention-R (second administration) for each 
participant will be calculated and reported. Descriptive statistics will be calculated and 
reported for the same data. 
PK parameters will be analyzed to evaluate the differences between the test and reference 
products by applying SCABE following EMA guidelines in investigation of 
bioequivalence regarding highly variable drug product (% of CVw >30), otherwise ABE 
will be applied. 
 
Analysis of Variance (ANOVA) will be used on ln-transformed pharmacokinetic 
parameters Cmax and AUC(0-t) for albendazole or albendazole sulfoxide. The ANOVA 
model will include participants, period and formulation as fixed effects.  
Each analysis of variance will include calculation of ratio of geometric least-squares 
means and the standard error associated with these ratios. The above statistical analyses 
will be done using PROC GLM of SAS® procedure. Significance level of 5% (alpha 
=0.05) will be used for the model. 
More technical and detailed description of the statistical analyses will be described in 
SAP of this study. This section is a summary of the planned statistical analyses of the 
most important endpoints including primary endpoints. 


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9.4.2.2. 
90% Confidence Interval 
90% confidence intervals for the ratio of geometric least squares means between drug 
formulations will be calculated for ln-transformed data of Cmax and AUC(0-t) for 
albendazole and albendazole sulfoxide. 
9.4.2.3. 
Ratio analysis 
Ratio of geometric least squares means of test and reference formulations will 
be computed and reported for ln-transformed pharmacokinetic parameters Cmax and 
AUC(0-t) for albendazole and albendazole sulfoxide. 
9.4.2.4. 
Intra-subject variability 
Intra-subject variability of reference study intervention-R will be computed and reported 
for ln-transformed pharmacokinetic parameters Cmax and AUC(0-t) for albendazole and 
albendazole sulfoxide. 
The existence of outlier subjects that inflate the intra-subject variability will be assessed. 
In case of such outliers, results will be reported with and without those outliers 
9.4.2.5. 
Missing and non-reportable values 
If 1 or more NQ values occur in a profile before the first measurable concentration, they 
will be assigned a value of zero concentration.  
 
If a single NQ value occurs between measurable concentrations in a profile, the NQ 
should be omitted (set to missing) in the derivation of pharmacokinetic parameters and 
statistical analysis.  
  
If 2 or more NQ values occur in succession between measurable concentrations, the 
values in question will be set to missing. For the derivation of pharmacokinetic 
parameters, these NQs will be omitted. The NQ values will be set to 0 and the trapezoidal 
rule will be applied to all the observed data. 
  
NQs which occur after the last measurable concentration will be omitted (set to missing) 
in the derivation of pharmacokinetic parameters and statistical analysis. 
Any missing samples (M) concentration value will be disregarded in pharmacokinetic 
and statistical analysis. 
9.4.2.6. 
Intercurrent event and handling of missing data 
The data will be affected by occurrence of the intercurrent event and only data available 
while the patient is receiving the treatment will be used under while-on treatment policy 
strategy. Participant level missing data will not be imputed, and available data will be 
used in the analysis. 


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In the case of emesis/vomiting or use of  prohibited/rescue medication, the data for that 
period will not be used for the analysis of PK parameters relating to the primary endpoint 
using hypothetical strategy. 
 
9.4.2.7. 
Bioequivalence Criteria 
Based on the statistical results of 90% confidence interval for the ratio of the geometric 
least square means for both ln-transformed pharmacokinetic parameters Cmax and AUC(0-
t), conclusion will be drawn for Test Study Intervention-T vs. Reference Study 
Intervention-R for albendazole with following considerations. 
For Cmax and AUC(0-t):  
1. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) ≤ 30% 
then bioequivalence of the test study intervention with that of the reference study 
intervention will be concluded, if the 90% confidence interval falls within the 
acceptance range of 80.00–125.00% for ln-transformed pharmacokinetic parameter 
Cmax and AUC(0-t). 
2. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) > 30% 
then Cmax and/or AUC(0-t) limit will be widened using scaled-average-bioequivalence. 
Under scaled-average-bioequivalence, [U,L]  = exp [±k·sWR] where U is the upper limit 
of the acceptance range, L is the lower limit of the acceptance range,  k is the regulatory 
constant set to 0.760 and SWR is the within-subject standard deviation of the ln 
transformed values of Cmax and/or AUC(0-t) of the reference study intervention. 
3. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) ≥ 50% 
then Cmax and/or AUC(0-t) bioequivalence limits will be widened to a maximum of 
69.84 – 143.19%.  
Bioequivalence of the test study intervention with that of the reference study 
intervention will be concluded for Cmax and/or AUC(0-t), if both of the following 
conditions are satisfied: 
• 
The 90% confidence interval for ln-transformed data of Cmax and/or 
AUC(0-t) falls within the newly widen range [U, L] = exp [±k·sWR], which 
is based upon the within-subject variability observed for Cmax. 
• 
The geometric least square mean ratio (GMR) of test to reference for 
Cmax and/or AUC(0-t) falls within the acceptance range of 80.00–
125.00%. 
Data of metabolite albendazole sulfoxide will be provided as supportive information 
only. 
9.4.3. 
Secondary Endpoint(s)/Estimand(s) Analysis 
Statistical analysis for secondary endpoints will include descriptive statistics for the 
following pharmacokinetic parameters:  


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Albendazole: AUC0-∞, Tmax, t1/2, λz and AUC_%Extrap_obs 
Albendazole sulfoxide: AUC0-∞, AUC0-t, Cmax, Tmax, t1/2, λz and 
AUC_%Extrap_obs. 
Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, SD, median, 
minimum, maximum and geometric mean with 95% CI) will be presented for 
untransformed secondary PK parameters. 
Average values of Test Study Intervention-T and Reference Study Intervention-R for PK 
parameters for each participant will be calculated and reported. Descriptive statistics will 
be calculated and reported for the same data.  
Individual values of PK parameters for Test Study Intervention-T (first administration), 
Test Study Intervention-T (second administration), Reference Study Intervention-R (first 
administration) and Reference Study Intervention-R (second administration) for each 
participant will be calculated and reported. Descriptive statistics will be calculated and 
reported for the same data. 
In case of treatment discontinuation due to any reason, only the data available before the 
occurrence of intercurrent event will be used to estimate secondary PK parameters using 
while-on-treatment policy strategy. 
If any participant experience emesis/vomiting or if a prohibited/rescue medication is used 
by any participant, the participant’s data for that period will not be used for the analysis of 
secondary endpoints related to PK using hypothetical strategy. 
Treatment policy strategy will be used to analyze the secondary endpoints related to safety 
to make use of all available data for a participant. 
9.4.4. 
Safety Analysis 
Safety data will be presented in tabular and/or listing format and summarized descriptively.  
Number and percentage will be presented for incidence of AE. 
Descriptive statistics (N, n, mean, SD, median, minimum and maximum) will be presented 
for absolute and change from baseline values of vital signs parameters at each timepoint. 
Comprehensive description for statistical analyses of safety endpoints will be described 
in the SAP. 
9.5. 
Interim analyses 
Not Applicable 
9.6. 
Sample size determination 
Based on the WHO guideline for albendazole, the maximum intra-subject variability 
observed for primary pharmacokinetic parameters Cmax and AUC(0-t) could be up to ~ 


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68% and 62% respectively. For this sample size calculation, a product difference of up to 
10% (i.e. T/R ratio as 90.0-111.1%) has been assumed. 
 
The sample size was determined using R software considering the following assumptions: 
a. T/R ratio = 90.0-111.1%  
b. Intra-Subject CV (%) ~ 68% (Cmax) and 62% (AUC(0-t)), or 48% (both)  
c. Significance Level = 5% 
 
Correlation between Cmax and AUC(0-t) was calculated to be very high, based on an in-
house albendazole study (GSK study O7921353). The exact Cmax and AUC(0-t) 
covariance matrix was calculated from this historical study (Table 10) and used to simulate 
realistic Cmax and AUC(0-t) values based on multivariate normal distributions. These 
values were then used to perform joint power calculation on the basis of inclusion of 70 
participants with varying levels of missing data. To determine the power, success rates 
were based on 1000 replicates of the study design. 
Table 10 
Covariance matrix used for Cmax and AUC(0-t) in power calculations 
 
AUC(0-t) 
Cmax 
AUC0-t 
0.814 
0.685 
Cmax 
0.685 
0.747 
 
Table 11 
Joint power calculation results (N=1000) across various scenarios of 
missing data 
Scenario 
Joint Power (CV% = 
48% for both Cmax and 
AUC(0-t))  
Joint Power (CV% = 
68% 
and 
62% 
for 
AUC(0-t) and Cmax 
respectively) 
48 participants have complete data 
for Cmax and AUC(0-t) for all 4 
periods and 22 Participants data is 
completely missing 
90.3% 
93.7% 
48 participants have complete data 
for Cmax and AUC(0-t) for all 4 
periods, 10 participants have 2 
period data and 12 participants data 
is completely missing  
93.4% 
95.8% 
48 participants have complete data 
for Cmax and AUC(0-t) for all 4 
91.5% 
94.9% 


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periods, 6 participants have data 
for 2 periods and 16 remaining 
participants have no data at all 
 
 
Based on these results, and the aforementioned covariance matrix, at least 48 participants 
would be required to power a study to 90% to establish bioequivalence under the 
assumptions highlighted above. Based on experience, ~30% dropouts and/or withdrawals 
(due to unavoidable reasons like medical ground, adverse events, own accord, etc.) should 
be considered, requiring a target inclusion of 70 participants for this study. In-house data 
showed the variance of Cmax and AUC to be closer to 48%, implying that the above sample 
size calculation takes into account the worst-case scenario, and may in fact provide a power 
of >95%. 
Sufficient number of volunteers will be asked to report on the day of check-in of period I 
in order to ensure that at least 70 participants will be enrolled in the beginning of the 
study. Subsequent dropouts after dosing in period I will not be replaced. 
 
Note: Additional participants if available, may be checked-in on the day of check in of 
period I to compensate for any dropout prior to dosing of period I. These participants will 
be dosed if there are dropouts prior to dosing in period I. If there are no dropouts, these 
participants will be checked-out without being dosed after completion of dosing in period 
I. 
10. 
SUPPORTING 
DOCUMENTATION 
AND 
OPERATIONAL 
CONSIDERATIONS 
Clinical facility, Bioanalytical, Pharmacokinetic, Biostatistics and programming, Quality 
Assurance and Clinical laboratory Services: 
Lambda Therapeutic Research Ltd., 
Lambda House, Plot No. 38, Survey No. 388, 
Near Silver Oak Club, S. G. Highway, Gota, 
Ahmedabad - 382481, Gujarat, India. 
Tel. No.: +91-79-40202020 
Fax No. : +91-79-40202021 


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10.1. 
Appendix 1: Regulatory, ethical, and study oversight considerations 
10.1.1. 
Regulatory and ethical considerations 
• This study will be conducted in accordance with the protocol and with the following: 
o 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki (Brazil, October 2013) and CIOMS international ethical 
guidelines 
o 
Applicable ICH GCP guidelines: [ICH E6(R2) ‘Guideline for Good Clinical 
Practice’ (2016)] 
o 
Applicable laws and regulations including current version of the [New Drugs & 
Clinical Trial Rules, 2019 of CDSCO, Ministry of health and family welfare, 
Government of India], [Ethical guidelines for biomedical research on human 
participants, ICMR ((2017)] 
• Any significant change in the study procedure or study design will only be effected 
upon mutual agreement between the Sponsor and Lambda, and after obtaining a 
favorable opinion from the Ethics Committee. 
• All such changes will be documented in the amended version of the protocol and a 
summary of changes with reference to the previous version will be generated. The 
protocol amendments, ICF and other relevant documents must be submitted to an 
IRB/IEC as soon as possible by the investigator and reviewed and approved by the 
IRB/IEC before the study is initiated.  
• In cases where there is an immediate safety hazard to the participants, the amended 
protocol will be effective immediately and approval of the IEC/IRB will be obtained 
as soon as possible. 
• Protocols and amendments to the protocol will require health authority approval prior 
to initiation except for changes necessary to eliminate an immediate hazard to study 
participants. 
• This Protocol and the corresponding ICF used to obtain consent of study participants 
will be reviewed by the IEC/ IRB and the study will commence only after a written 
approval is obtained from the IEC/ IRB. 
• The investigator will be responsible for the following, as applicable: 
o 
Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 
o 
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
o 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
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10.1.2. 
Financial disclosure 
Not Applicable. 
10.1.3. 
Informed consent process 
• The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits and information regarding the study intervention to the 
participants/ LAR(s) and answer all questions regarding the study at the time of ICF 
presentation. This will be done through an oral presentation regarding the purpose, 
procedures to be carried out, potential hazards and rights of the participants, in their 
local language.  Participants will be encouraged to ask questions and clarify their 
doubts regarding any aspect of the study. 
• Potential participants/ LAR(s) must be informed that their participation is voluntary. 
They or their LARs will be required to physically sign/ put a thumb impression on a 
statement of informed consent that meets the requirements of 21 CFR 50, local 
regulations, ICH guidelines, HIPAA requirements, privacy and data protection 
requirements, where applicable, and the IRB/IEC or study center. 
• Participants will be required to sign / put a thumb impression on the informed consent 
form summarizing the discussion prior to check-in for the study.  Signature of the 
LAR/Impartial witness (if applicable) will be taken on the informed consent form in 
case the Participant is not able to sign on the informed consent form. Participants who 
fail to understand the informed consent procedure and/or are unable to communicate 
with the study personnel will not be enrolled. 
• The physical informed consent will be obtained before the participant gets enrolled in 
the study and the date of the physical consent was obtained. The authorized person 
obtaining the informed consent must also sign the ICF. 
• Participants must be reconsented to the most current version of the ICF(s) during their 
participation in the study. 
• The Participants will give their consent for participation in the trial by signing /putting 
a thumb impression on ICF, which will also be signed by the LAR/Impartial witness 
(if applicable) and Lambda’s person conducting the ICF presentation, principal 
investigator or designate. 
• A photocopy of ICF with the signature or thumb impression must be provided to the 
participant or their LAR, while the original will be retained at Lambda Therapeutic 
Research Ltd. 
10.1.4. 
Recruitment strategy 
Upon receiving of regulatory approval, ethics committee approval, study intervention 
availability at clinical site and tentative dates of clinical planning, our participant 
recruitment team will initiate calling the participants telephonically for screening to enroll 
enough participants in the study as per sample size defined in protocol. 


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10.1.5. 
Data protection 
• Participants will be assigned a unique identifier by study personnel. Any participant 
records or datasets that are transferred to the sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred. 
• GSK will ensure protection of the personal data of the investigator and site staff which 
is collected within the framework of and for the purpose of the study. 
• The participant/LAR must be informed that their personal study-related data will be 
used by the sponsor in accordance with local data protection law. The level of 
disclosure must also be explained to the participant /LAR that their data will be used 
as described in the informed consent. 
• The participant/LAR must be informed that their medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The contract between sponsor and study sites specifies responsibilities of the parties 
related data protection, including handling of data security breaches and respective 
communication and cooperation of the parties. 
• Information technology systems used to collect, process, and store study-related data 
are secured by technical and organizational security measures designed to protect such 
data against accidental or unlawful loss, alteration, or unauthorized disclosure or 
access. GSK and/or trusted third parties working on behalf of GSK and/or institutions 
working with GSK for the purposes of this study are contractually bound to protect 
participant coded data. GSK will protect participant coded data and will only share it 
as described in the ICF. 
10.1.6. 
Committees structure 
A SRT is in place for each GSK product. It comprises of a global cross-functional team 
responsible for the ongoing assessment of benefit-risk for a product. The SRT contribute 
to the continual assessment of incoming new efficacy and safety information.  
10.1.7. 
Dissemination of Clinical Study Data 
• The key design elements of this protocol and results summaries will be posted on 
www.ClinicalTrials.gov and/or GSK Clinical Study Register in compliance with 
applicable regulations/GSK policy. GSK will aim to register protocols summaries prior 
to study start and target results summaries submission within 12 months of primary/ 
study completion date. Where external regulations require earlier disclosure, GSK will 
follow those timelines.  
• Where required by regulation, summaries will also be posted on applicable national or 
regional clinical study registers. 
• Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the study report, and provided reasonable access to 


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statistical tables, figures, and relevant reports. GSK will also provide the investigator 
with the full summary of the study results, including a summary of trial results 
understandable to laypersons. The investigator is encouraged to share the plain 
language summary with the study participants, as appropriate. The full study report will 
be made available upon request, after decision on marketing authorization by 
regulatory authorities.   
• GSK will provide the investigator with the randomization codes and participant-level 
line listings for their site only after completion of the full statistical analysis. 
• GSK intends to make anonymized participant-level data from this study available to 
external researchers for scientific analyses or to conduct further research that can help 
advance medical science or improve patient care. This helps ensure the data provided 
by study participants are used to maximum effect in the creation of knowledge and 
understanding. 
10.1.8. 
Data quality assurance 
• All participant data relating to the study will be recorded on printed or electronic CRFs 
unless transmitted to the sponsor or designee electronically (e.g., laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF. 
• eCRF will be designed as per Lambda in-house SOP IND/CDM/0001-X (Clinical Data 
Management involvement for in-house studies). 
• The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source documents. 
• QTLs will be predefined in the [state location(s)] to identify systematic issues that can 
impact participant right, safety and/or reliability of study results. These predefined 
parameters will be monitored during the study, and important deviations from the QTLs 
and remedial actions taken will be summarized in the CSR. 
• Monitoring details describing strategy, including definition of study critical data items 
and processes (e.g., risk-based initiatives in operations and quality such as risk 
management and mitigation strategies and analytical risk-based monitoring, 
involvement of central reading mechanism) methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, remote, or on-site monitoring) are provided in the [monitoring plan] 
[contracts]. 
• The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
• The sponsor assumes accountability for actions delegated to other individuals (e.g., 
contract research organizations). 
• Records and documents, including signed ICF, pertaining to the conduct of this study 
must be retained by the investigator for 25 years from the issue of the final CSR/ 
equivalent summary unless local regulations or institutional policies require a different 
retention period. No records may be destroyed during the retention period without the 


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written approval of the sponsor. No records may be transferred to another location or 
party without written notification to the sponsor.  
 
10.1.9. 
Source documents 
• All clinical raw data generated during conduct of the study will be directly entered in 
the respective electronic source forms / eCRF. Electronic software (BizNET, IMPTrack 
etc.) will be used for capturing the data generated during conduct of the study as per 
in-house SOPs. The study specific activity such as study intervention administration, 
sample collection, meal distributions, vitals and clinical examination etc. will be 
directly entered into electronic source forms/eCRF. However, the activity like such as 
participant’s consent, duty delegations records etc. will be available in paper copy (wet 
ink signature).  
• All source data and transcribed data forms will be compiled by the study personnel 
assisting in the study and will be checked wherever applicable for completeness. 
Further, information of Type and location of data generated for study will be traceable 
from Trial Master File. 
• All bio-analytical raw data of sample processing and associated data such as solution 
preparation, role allocation etc. will be directly entered in the respective source data 
forms. The data acquisition system software will be used for the quantitative 
determination and Biolyte software will be used for review of generated data as per in-
house SOPs. All data related to the project will be in the custody of the designated 
study personnel until transferred to archives. 
• Once the concentration data is received from bio-analytical department through Biolyte 
software, data will be combined with randomization schedule and actual sampling time 
point, as applicable. Handling of the concentration data and pharmacokinetic and 
statistical analysis will be done as per in-house SOPs. All pharmacokinetic and 
statistical analysis will be performed on network drive. Archival of the 
pharmacokinetic and statistical data will be done as per defined archival procedure.  
• A paper source/forms (if required to be used due to temporary non-functioning of 
software or no provision to document in software) will be maintained and filed with 
project specific binders as per in-house SOPs. 
• The sponsor or designee will perform monitoring to confirm that data entered into the 
eCRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the 
study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements. 
• Copies of documents are shared with external third parties contracted by GSK for 
review by a central reader mechanism (e.g. endpoint adjudication committee; expert 
reader). The non-exhaustive list of documents shared to inform the central reader may 
include, discharge summaries, imaging reports, ECG reports etc. Participant names or 
any information which would make the participant identifiable or is not essential for 
the central reader mechanism will be redacted by the investigator sites prior to 
transfer.  Details of the list of documents and the redaction procedure are provided in 


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the site manual or equivalent. These documents will be used by the third party solely 
for the purpose indicated within this protocol.  
10.1.10. 
Study and site start and closure 
Start of study and first act of recruitment 
The start of study and the first act of recruitment are defined as FSFV (first ICF signature 
date) at a country-level. 
Study/Site Termination 
The Lambda Therapeutic Research Ltd. for safety reasons and the sponsor reserves the 
right to discontinue the study at any time. The sponsor and the IEC/ IRB will be 
immediately informed in case the study is terminated by Lambda. Reasons for this 
termination will be provided to the participants. The study may be terminated by the 
IEC\IRB if there are major violations of ethical considerations or due to any serious adverse 
event. 
10.1.11. 
Publication policy 
The results of this study may be published in peer reviewed scientific literature and/or 
presented at scientific meetings. The sponsor will comply with the requirements for 
publication of study results in accordance with standard editorial and ethical practice and 
as per the sponsor’s internal policy. Authorship will be determined by mutual agreement 
and in line with ICMJE authorship requirements. 


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10.2. 
Appendix 2: Clinical laboratory tests 
Table 12 
Protocol-required safety laboratory tests  
 
PARAMETERS 
Visits* 
Hematology 
1 
2 
3 
4 
1 
Hemoglobin [Hb] 
X 
 
 
X 
2 
RBC count 
X 
 
 
X 
3 
HCT 
X 
 
 
X 
4 
MCV 
X 
 
 
X 
5 
MCH 
X 
 
 
X 
6 
MCHC 
X 
 
 
X 
7 
RDW CV 
X 
 
 
X 
8 
Platelet count 
X 
 
 
X 
9 
WBC (total) 
X 
 
 
X 
10 Neutrophils % 
X 
 
 
X 
11 Lymphocytes % 
X 
 
 
X 
12 Eosinophils % 
X 
 
 
X 
13 Monocytes % 
X 
 
 
X 
14 Basophils % 
X 
 
 
X 
15 Neutrophils abs 
X 
 
 
X 
16 Eosinophils abs 
X 
 
 
X 
 
Urine Parameters 
1 
2 
3 
4 
1 
Specific 
Gravity 
6 
pH 
X 
 
 
 
2 
Leucocytes 
7 
Protein 
X 
 
 
 
 
PARAMETERS 
Visits* 
Biochemistry 
1 
2 
3 
4 
1 
Random Glucose 
X  
 
 
2 
Bilirubin Total 
X  
X 
X 
3 
Total Protein 
X  
 
X 
4 
Albumin 
X  
 
X 
5 
Serum Globulin 
X  
 
X 
6 
A/G ratio 
X  
 
X 
7 
SGOT (AST) 
X  
X 
X 
8 
SGPT (ALT) 
X  
X 
X 
9 
Creatinine 
X  
 
X 
10 Blood Urea Nitrogen 
X  
 
X 
11 Sodium 
X  
 
 
12 Potassium 
X  
 
 
13 Chloride 
X  
 
 
14 Alkaline phosphatase 
X  
 
 
 
Microbiology & Serology 
1 
2 
3 
4 
1 HIV AB (1 & 2) 
X 
 
 
 
2 Anti HCV 
X 
 
 
 
3 HBsAg 
X 
 
 
 
 


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3 
Bilirubin 
8 
Ketones X 
 
 
 
4 
Urobilinogen 9 
Glucose X 
 
 
 
5 
Erythrocytes 10 
Nitrite 
X 
 
 
 
11 Microscopic examination# 
X 
 
 
 
 
Drug of abuse/alcohol test 
1 
2 
3 
4 
1 Drugs of abuse in urine+ 
X X 
 
 
2 Breath alcohol test 
X X 
 
 
 
 
Hormonal Assay 
1 
2 
3 
4 
1 β-HCG (For females) 
X X 
 
X 
 
 
*Visits: 1) Screening | 2) Prior to check-in of each period | 3) Prior to check-in period II, III and IV | 4) End Study (at the 
time of check-out of period IV). 
# As applicable 
+ Morphine, Cannabinoids, Amphetamines, Barbiturates, Benzodiazepines, Cocaine 


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10.3. 
Appendix 3: AEs and SAEs: Definitions and procedures for recording, 
evaluating, follow-up, and reporting 
10.3.1. 
Definition of AE 
AE definition 
• An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of a study intervention, whether or not considered related to 
the study intervention. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of a study intervention. 
 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator (i.e., not related to progression of 
underlying disease). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New condition detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected intervention- intervention 
interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae. 
•  Significant failure of an expected pharmacologic or biological action. 
• 
Events that occur as a result of protocol-mandated procedures (i.e. invasive 
procedures, modification of participant’s previous therapeutic regimen). 
Events NOT Meeting the AE Definition  
• 
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 


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• 
The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition. 
• 
Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital, admission for routine examination.). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen. Pre-existing diseases 
will be recorded in the medical history section of the eCRF. 
• 
Hospitalization for elective treatment of a pre-existing condition (known or 
diagnosed before signing the informed consent) that did not worsen from baseline. 
10.3.2. 
Definition of SAE 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or 
more of the criteria listed: 
a. Results in death 
b. Is life threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or outpatient setting. Complications that occur during hospitalization are AE. 
If a complication prolongs hospitalization or fulfills any other serious criteria, the 
event is serious. When in doubt as to whether “hospitalization” occurred or was 
necessary, the AE should be considered serious. 
• 
Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• 
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (e.g., sprained ankle) that may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption. 


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e. 
Is a congenital anomaly/birth defect in the offspring of a study participant 
 
f. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, 
stillbirth, ectopic pregnancy) 
10.3.3. 
Definition of CV events   
Not Applicable 
10.3.4. 
Definition of TEAE 
Not Applicable 
10.3.5. 
Recording, assessment and follow-up of AE, SAE and pregnancies  
10.3.5.1. 
AE and SAE recording 
The following will be recorded during the conduct of the study: 
a) 
Clinical Examination and recording of vital signs at regular intervals. 
b) 
Concomitant therapy. 
c) 
Adverse event monitoring and reporting. 
Handling of adverse events: 
Participants will be monitored throughout the study period for adverse events. Participants 
will be instructed to bring to the notice of the nurse or the doctor or study personnel (e.g. 
Custodian), any adverse event that may occur during their stay at the clinical facility. 
Participants will also be specifically asked about any adverse events throughout the study 
period during the recording of vital signs. A physician will be available round the clock 
during the time of Participants stay/housing at the clinical facility. All adverse events will 
be treated by the attending physician at the clinical facility, or in a nearby reputed hospital. 
All adverse events will be followed up wherever possible until resolution or until the 
investigator believes there will be no further change. This may involve additional visits.  
All adverse events, including both observed or voluntarily reported problems; complaints, 
signs or symptoms occurring after the first dose administration shall be recorded on the 
relevant page "Adverse Event/Medical Event Record Form" of eCRF irrespective of its 
association with the ongoing study medication. Prior to first dose administration in each 
participant, the event will be considered as a medical event and the aforementioned form 
will be completed by encircling “Medical Event” in the title. 
Each adverse event shall be evaluated for duration, severity, seriousness and 
unexpectedness, action taken, date and time of resolution and association with the study 
treatment. The study may be suspended or terminated depending on the seriousness of the 
adverse events. 


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The IEC/IRB, regulatory bodies and the Sponsor shall be informed regarding the same as 
per local regulatory requirements.  
Handling of Serious Adverse Event:   
In case of Serious Adverse Events, the Sponsor or Sponsor’s representative, licensing 
authority and IEC/IRB will be informed by any available mode of communication within 
24 hours of their occurrence or as soon as the initial treatment is provided. In case, the 
Investigator fails to report any serious adverse event within the stipulated period, they shall 
have to furnish the reason for the delay to the satisfaction of the Licensing Authority along 
with the report of the serious adverse event. The report of serious adverse event, after due 
analysis shall be forwarded by principal investigator to sponsor, Licensing Authority, as 
referred in as referred in clause (ix)-Section 35 of Part-B of Chapter-V of New Drugs & 
Clinical Trial Rules, 2019, Chairman of IEC/IRB (and the Head of the institution where 
the trial has been conducted, if applicable) within fourteen days of the occurrence of the 
serious adverse event.  
10.3.5.2. 
Assessment of intensity 
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to one of the following categories:  
• 
Mild: 
A type of AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual activities 
of daily living. 
• 
Moderate:  
A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the research 
participant. 
• 
Severe:  
A type of AE that interrupts usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention.   
10.3.5.3. 
Assessment of causality 
Causality term 
Assessment criteria 
Certain 
• Event or laboratory test abnormality, with plausible time 
relationship to drug intake 
• Cannot be explained by disease or other drugs 
• Response 
to 
withdrawal 
plausible 
(pharmacologically, 
pathologically) 
• Event definitive pharmacologically or phenomenologically (i.e. 


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• 
The investigator is obligated to assess the relationship between study intervention and 
each occurrence of each AE/SAE. The investigator will use clinical judgment to 
determine the relationship. 
10.3.5.4. 
Assessment of outcomes 
The investigator will assess the outcome of all serious and nonserious AEs recorded during 
the study as: 
• 
Recovered/resolved 
an objective and specific medical disorder or a recognized 
pharmacological phenomenon) 
• Rechallenge satisfactory, if necessary 
Probable/Likely 
• Event or laboratory test abnormality, with reasonable time 
relationship to drug intake 
• Unlikely to be attributed to disease or other drugs 
• Response to withdrawal clinically reasonable 
• Rechallenge not required 
Possible 
• Event or laboratory test abnormality, with reasonable time 
relationship to drug intake 
• Could also be explained by disease or other drugs 
• Information on drug withdrawal may be lacking or unclear 
Unlikely 
• Event or laboratory test abnormality, with a time to drug intake 
that makes a relationship improbable (but not impossible) 
• Disease or other drugs provide plausible explanations 
Conditional/ 
Unclassified 
• Event or laboratory test abnormality 
• More data for proper assessment needed, or 
• Additional data under examination 
Unassessable/ 
Unclassifiable 
• Report suggesting an adverse reaction 
• Cannot be judged because information is insufficient or 
contradictory 
• Data cannot be supplemented or verified 
Unrelated 
• The adverse event is clearly NOT related to the investigational 
medicinal product 
• A clinical event with an incompatible time relationship and which 
could be explained by underlying disease or other drugs or 
chemicals 


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• 
Recovering/resolving 
• 
Not recovered/not resolved 
• 
Recovered with sequelae/resolved with sequelae 
• 
Fatal (SAEs only). 
10.3.5.5. 
Follow-up of AEs, SAEs, pregnancies or any other events of interest 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by Sponsor 
to elucidate the nature and/or causality of the AE or SAE as fully as possible. This 
may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
• 
If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Sponsor with a copy of any postmortem 
findings including histopathology. 
• 
New or updated information will be recorded in the originally submitted documents. 
• 
The investigator will submit any updated SAE data to Sponsor within 24 hours of 
receipt of the information. 
After the initial AE/SAE /pregnancy] or any other event of interest, the investigator is 
required to proactively follow each participant at subsequent visits/contacts. All SAEs, 
(as defined in the Section 8.4.4), will be followed until the event is resolved, stabilized, 
otherwise explained, or the participant is lost to follow-up. 
Other nonserious AEs must be followed until 12 months after end of the studyor until the 
participant is lost to follow-up. 
Follow-up during the study 
AEs documented at a previous visit/contact and defined as not recovered/not resolved or 
recovering/resolving will be reviewed at subsequent visits/contacts until 12 months after 
the end of the study or until the participant is lost to follow-up. 
If a participant dies during their participation in the study or during a recognized follow-
up period, GSK will be provided with any available postmortem findings, including 
histopathology. 
Follow-up of pregnancies 
Pregnant participants will be followed to determine the outcome of the pregnancy. At the 
end of the pregnancy, whether full-term or premature, information on the status of the 
mother and child will be forwarded to GSK using the pregnancy follow-up report and the 
AE Report if applicable. Generally, the follow-up period does not need to be longer than 
6 to 8 weeks after the estimated date of delivery. 


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Regardless of the reporting period for SAEs in this study, if the pregnancy outcome is an 
SAE, it should always be reported as such. 
Furthermore, the investigator must report any SAE occurring as a result of a poststudy 
pregnancy that is considered by the investigator to be reasonably related to the study 
intervention, to GSK as described in the Section 10.3.5.7. 
10.3.5.6. 
Updating of SAE and pregnancy information after removal of write 
access to the participant’s eCRF 
When additional SAE or pregnancy information is received after write access to the 
participant’s eCRF is removed, new or updated information should be recorded on the 
appropriate paper report, with all changes signed and dated by the investigator. The 
updated report should be sent to the Study contact for reporting SAEs (refer to Section 
8.4.3). 
10.3.5.7. 
Reporting of SAEs and pregnancies 
SAE Reporting to Sponsor via an Electronic Data Collection Tool 
• 
The primary mechanism for reporting an SAE to Sponsor will be the electronic data 
collection tool. 
• 
If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to report the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as it becomes 
available. 
• 
After the study is completed at a given site, the electronic data collection tool will be 
taken offline to prevent the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken offline, then the site can report this information on a paper SAE form (see next 
section) or to the Sponsor by telephone. 
• 
If the site during the course of the study or poststudy becomes aware of any serious, 
nonserious AEs, pregnancy exposure, related to any GSK non-IMP they will report 
these events to GSK or to the concerned competent authority via the national 
spontaneous reporting system.  These will be classified as spontaneous ICSRs. 
• 
Contacts for SAE reporting can be found in Section 8.4.8. 
SAE Reporting to Sponsor via Paper Data Collection Tool 
• 
Email/facsimile transmission of the SAE paper data collection tool is the preferred 
method to transmit this information to the Sponsor. 
• 
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE data collection tool within the designated reporting 
timeframes. 


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• 
Contacts for SAE reporting can be found in Section 8.4.8. 


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10.4. 
Appendix 4: Contraceptive and barrier guidance 
10.4.1. 
Definitions 
10.4.1.1. 
Woman of Childbearing Potential (WOCBP) 
Women in the following categories are considered WOCBP (fertile): 
Adolescents of childbearing potential: Tanner stage ≥2 (post-thelarche) irrespective of the 
occurrence of menarche or following menarche. 
From the time of menarche until becoming postmenopausal unless permanently sterile (see 
below) 
Note: Menarche is the first onset of menses in a young female. Menarche is normally 
preceded by several changes associated with puberty including breast development and 
pubic hair growth.  
10.4.1.2. 
Woman of Nonchildbearing Potential (WONCBP) 
Women in the following categories are considered WONCBP: 
• Premenarchal: Tanner stage 1 (prepubertal) 
Permanently sterile due to one of the following procedures: 
a. Documented hysterectomy 
b. Documented bilateral salpingectomy 
c. 
Documented bilateral oophorectomy 
For permanently sterile individuals due to an alternate medical cause other than the 
above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), 
investigator discretion should be applied to determining study entry. If reproductive 
status is questionable, additional evaluation should be considered. 
Note: Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview. 
Postmenopausal female 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
• 
A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or HRT. However, 
in the absence of 12 months of amenorrhea, confirmation with more than one FSH 
measurement is required. 
• 
Females on HRT and whose menopausal status is in doubt must discontinue HRT to 
allow confirmation of postmenopausal status before study enrollment. 
Not Applicable 


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10.5. 
Appendix 5: Liver safety: suggested actions and follow-up assessments  
Laboratory assessment for liver function test will be performed at the time of screening 
and prior to check-in of period II, III and IV. 


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10.6. 
Appendix 6: Clinically acceptable values 
Parameters 
Male 
Female 
Unit 
HEMATOLOGY 
Hemoglobin 
(Hb) 
≥ 12.5 to   ≤16.5 
≥ 11.5 to ≤14.7 
g/dL 
RBC Count 
≥ 4.1 X 10^6 to   ≤ 6.3 X 
10^6   
≥ 3.6X 10^6 to ≤ 5.5 X 
10^6   
/ µL 
HCT 
≥ 37 to ≤ 52 
≥ 32 to ≤ 48 
% 
MCV 
68 - 111 
61 - 115 
fL 
MCH 
20 - 40 
19 - 40 
pg 
MCHC 
27 - 40 
27 - 40 
g/dL 
RDW CV 
09 - 22 
09 - 23 
% 
Platelet Count 
≥ 150 X 10^3 
≥ 150 X 10^3 
/ µL 
WBC (Total) 
4.2 - 11.5 X 10^3 
4.2 - 11.5 X 10^3 
/ µL 
Neutrophils% 
30 - 90 
30 - 90 
% 
Neutrophils (abs) 
1.5 - 9 
1.5 - 9 
10^3 / 
µL 
Lymphocytes% 
12 - 50 
12 - 50 
% 
Eosinophils% 
0 - 18 
0 - 18 
% 
Eosinophils (abs) 
0.015 – 1.8 
0.015 – 1.8 
10^3 / 
µL 
Monocytes % 
01 - 13 
01 - 13 
% 
Basophils % 
0 - 03 
0 - 03 
% 


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Parameters 
Male 
Female 
Unit 
BIOCHEMISTRY 
Random Glucose 
≤ 200 
≤200 
mg/dL 
Bilirubin Total 
≤ 1.5 mg/dL 
≤ 1.5 mg/dL 
mg/dL 
Total Protein 
6.2 - 9.5 
6.2 - 9.5 
g/dL 
Albumin 
3.4 - 5.8 
3.4 - 5.8 
g/dL 
Globulin 
2.2 - 4.8 
2.2 - 4.8 
g/dL 
A/G ratio 
1.0 - 2.5 
1.0 - 2.5 
 
SGOT (AST) 
≤ 73.0 
≤ 46.0 
U/L 
SGPT (ALT) 
≤ 82.0 
≤ 56.0   
U/L 
Creatinine 
≤ 1.1 mg/dL  
≤ 0.9 mg/dL  
mg/dL 
Blood Urea 
≤ 40 
≤ 40 
mg/dL 
Sodium 
129 - 150 
129 - 150 
mmol/L 
Potassium 
3.5 - 5.7 
3.5 - 5.7 
mmol/L 
Chloride 
92 - 113 
92 - 113 
mmol/L 
Alkaline 
Phosphatase 
< 1.5 times upper limit of 
normal 
< 1.5 times upper limit of 
normal 
U/L 
Blood Urea 
Nitrogen 
≤ 22 
≤ 22 
mg/dL 
URINE ANALYSIS 
Specific Gravity 
01 - 1.03 
01 - 1.03 
 


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Parameters 
Male 
Female 
Unit 
PH 
4.5 - 08 
4.5 - 08 
 
Glucose 
Absent 
Absent 
 
Protein 
Absent 
Absent 
 
Bilirubin 
Absent 
Absent 
 
Ketones 
Absent 
Absent 
 
Urobilinogen 
Absent 
Absent 
 
Erythrocytes 
Up to 2+ 
Up to 3+ 
 
Leucocytes 
Up to 2+ 
Up to 3+ 
 
Nitrite 
Absent 
Absent 
 
Epithelial 
Occasional 
Occasional 
/ HPF 
Pus Cells 
Up to 8 
Up to 10 
/ HPF 
Red Cells 
Up to 8 
Up to 10 
/ HPF 
Cast 
Absent 
Absent 
 
Crystal 
Absent 
Absent 
 
Trichomonas 
Absent 
Absent 
 
Yeast 
Absent 
Absent 
 
Bacteria 
Absent 
Absent 
 
Amorphous 
Absent 
Absent 
 
 
 


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10.7. 
Appendix 7: High fat high calorie vegetarian breakfast menu 
Food 
Items 
Serving
s 
Ingredient
s 
Qty. Of 
Ingredient
s 
Calori
e 
(Kcal) 
CHO 
(gms) 
Fats 
(gms) 
Protein
s (gms) 
Toast 
1 no 
Bread 
1 Slice 
61.25 
12.98 
0.18 
1.95 
Butter 
10 gms 
72.90 
0.00 
8.10 
0.00 
*Chana   
Chat 
60 gms 
Chana 
20 gms 
72.00 
12.18 
1.06 
3.42 
Onions 
5 gms 
2.95 
0.63 
0.01 
0.09 
Peanuts 
10 gms 
56.7 
2.61 
4.01 
2.53 
Oil 
2 ml 
18.00 
0.00 
2.00 
0.00 
Vegetabl
e Cutlets 
(Approx 
130 gms) 
1 
serving 
/ 2 nos 
Potatoes 
50 gms 
48.50 
11.30 
0.05 
0.80 
Cheese 
40 gms 
139.20 
2.52 
10.04 
9.64 
Onions 
5 gms 
2.95 
0.63 
0.01 
0.09 
Bread 
¼ Slice 
15.31 
3.24 
0.04 
0.49 
Oil 
10 ml 
90.00 
0.00 
10.00 
0.00 
Paneer 
50 gms 
146.00 
3.95 
11.50 
6.70 
Milk 
1 
serving 
Milk 
200 ml 
192.00 
10.00 
13.00 
8.60 
Sugar 
5 gms 
19.90 
4.97 
0.00 
0.01 
TOTAL 
937.66 
65.01 
60.00 
34.32 
NUTRIENT CALORIES 
260.04 
540.00 
137.28 
NUTRIENT CALORIES AS % TOTAL 
27.73
% 
57.59
% 
14.64% 


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*Soaked and boiled Chana will be 40 gms, Soaked and boiled Peanuts will be 15 
gms. 
Salt, Black pepper, Chat Masala, Green Chillies, Coriander and Tomato Ketchup 
may be as taste enhancers 


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11. 
REFERENCES 
1. Albendazole local prescribing information, India.  
2. Application of reference-scaled criteria for AUC in bioequivalence studies 
conducted for submission to PQT/MED. World Health Organisation. 02 July 2021 
3. Public Assessment Report, Albendazole, DE/H/5407/001/DC, Date: 02.04.2019 
4. US FDA guidance Statistical Approaches to Establishing Bioequivalence 
Guidance for Industry. 
5. WHO Expert Committee on Specifications for Pharmaceutical Preparations. 
Fifty-fifth report (TR1033), annex 6: Multisource (generic) pharmaceutical 
products: guidelines on registration requirements to establish interchangeability. 
World Health Organisation. 25 March 2021 
 


Signature Page for  221030 TMF-16298784 v1.0
Signature Page for TMF-16298784 v1.0
Reason for signing: Approved
Name
Role: Approver
Date of signature: 04-Jul-2023 12:01:13 GMT+0000
PPD

SAP_001.pdf: 
PPD
PPD
PPD
PPD
PPD
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SPONSOR’s SIGNATURE: 
 
 
Approved by 
Name 
 
Designation 
 
Organization Name 
 
Signature & Date 
 
 


 
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INDEX 
ABBREVIATIONS AND DEFINITIONS ................................................................................ 4 
1 Introduction ........................................................................................................................... 6 
2 Objective, Endpoints and Estimands .................................................................................... 6 
3 Overall Study Design ............................................................................................................ 9 
3.1 Study Design ........................................................................................................................ 9 
3.2 Study Intervention(s) Administered ...................................................................................... 9 
3.3 Sample Size ........................................................................................................................... 9 
3.4 Randomization .................................................................................................................... 11 
3.5 PK Sampling Schedule ....................................................................................................... 11 
4 Analysis sets........................................................................................................................ 12 
5 Assessment of Pharmacokinetic Parameters ....................................................................... 12 
5.1 Pharmacokinetic analysis ................................................................................................... 12 
5.2 Pharmacokinetic Parameters ............................................................................................... 13 
6 Statistical Considerations .................................................................................................... 14 
6.1 Statistical Hypotheses ......................................................................................................... 14 
6.2 Multiplicity Adjustment ...................................................................................................... 15 
6.3 Statistical Analysis .............................................................................................................. 15 
6.3.1 General considerations ............................................................................................ 15 
6.3.2 Primary Endpoint(s)/Estimand(s) Analysis ............................................................ 15 
6.3.2.1 Descriptive statistics ........................................................................................... 15 
6.3.2.2 Analysis of Variance (ANOVA) ......................................................................... 16 
6.3.2.3 90% Confidence Interval .................................................................................... 16 
6.3.2.4  Ratio analysis ...................................................................................................... 16 
6.3.2.5 Intra-subject variability ....................................................................................... 16 
6.3.2.6 Missing and non-reportable values ..................................................................... 16 
6.3.2.7  Intercurrent event and handling of missing data ................................................. 16 
6.3.2.8 Bioequivalence criteria ....................................................................................... 17 
6.3.3 Secondary Endpoint(s)/Estimand(s) Analysis ........................................................ 17 
7 Safety Assessment and Analysis ......................................................................................... 18 
7.1 Safety Assessment .............................................................................................................. 18 
7.2 Safety Analysis ................................................................................................................... 19 
8 Change from the protocol ................................................................................................... 20 
9 Interim analysis ................................................................................................................... 20 
10 Software Information for Analysis ..................................................................................... 20 
11 Format Specifications for outputs ....................................................................................... 20 
12 List of Tables ...................................................................................................................... 22 
13 List of Listings .................................................................................................................... 23 
14 List of Figures ..................................................................................................................... 24 
15 List of In-text Tables ........................................................................................................... 25 
16 Statistical Outputs ............................................................................................................... 25 
17 References ........................................................................................................................... 26 
18 Tables and Listings shells ................................................................................................... 27 
 
 
 


 
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ABBREVIATIONS AND DEFINITIONS 
 
λz 
: 
First order rate constant associated with the terminal (log-linear) 
portion of the curve 
Abs 
: 
Absolute 
ACE 
: 
Angiotensin converting enzyme 
AE 
: 
Adverse event 
ALT 
: 
Alanine aminotransferase 
ANC 
: 
Absolute neutrophil count 
ANOVA 
: 
Analysis of variance 
AST 
: 
Aspartate aminotransferase 
AUC 
: 
Area under the curve 
AUC_%Extrap_obs 
: 
% Residual area 
AUC0-∞ 
: 
Area under the plasma concentration versus time curve from time 
zero to infinity 
AUC(0-t) 
: 
Area under the plasma concentration-time curve up to the last 
measured time point 
BE 
: 
Bioequivalence 
BMI 
: 
Body mass index 
BSA 
: 
Body surface area 
Cmax 
: 
Maximal (peak) plasma concentration 
cm 
: 
Centimeter 
CFB 
: 
Change from baseline 
CI 
: 
Confidence interval 
COVID  
: 
Corona virus disease 
CV 
: 
Coefficient of variation  
CRO 
: 
Contract research organization 
ECG 
: 
Electrocardiogram 
GMR 
: 
Geometric mean ratio 
Hb 
: 
Hemoglobin 
HBsAg 
: 
Hepatitis B surface antigen 
HCV 
: 
Hepatitis C virus 
HCT 
: 
Hematocrit 
HIV 
: 
Human immunodeficiency virus 
h/hr/hrs 
: 
Hours 
ICH 
: 
The 
international 
council 
for 
harmonisation 
of 
technical 
requirements for pharmaceuticals for human use 


 
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IP 
: 
Investigational product 
kg 
: 
Kilograms 
ln 
: 
Logarithmic value to the base ‘e’ 
m2 
: 
Meter square 
MCH 
: 
Mean cell hemoglobin 
MCHC 
: 
Mean corpuscular hemoglobin concentration 
MCV 
: 
Mean corpuscular volume 
MedDRA 
: 
Medical dictionary for regulatory activities 
mg 
: 
Milligram 
min 
: 
Minimum 
mL 
: 
Milliliter 
NQ 
: 
Non-quantifiable 
OTC 
: 
Over the counter medicine 
PK 
: 
Pharmacokinetic(s) 
PT 
: 
Preferred term 
RBC 
: 
Red blood cell 
RDW-CV 
: 
Red cell distribution width - coefficient of variation 
R2 
: 
Goodness of fit statistic for the terminal phase, adjusted for the 
number of points used in the estimation of λz 
SAE 
: 
Serious adverse event 
SAP 
: 
Statistical analysis plan 
SAS 
: 
Statistical analysis system 
SD 
: 
Standard deviation 
SGOT 
: 
Serum glutamic-oxaloacetic transaminase 
SGPT 
: 
Serum glutamic pyruvic transaminase 
SCABE 
: 
Scaled average bioequivalence 
SOC 
: 
System organ class 
SWR 
: 
Within-subject standard deviation of the reference study intervention  
t1/2 
: 
Terminal half-life 
TOST 
: 
Two one-sided t-test 
Tmax 
: 
Time of the maximum measured plasma concentration  
WBC 
: 
White blood cell 
WHO 
: 
World health organization 


 
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1 Introduction 
This statistical analysis plan provides the framework for the analysis and summarization of the 
data generated from the study conducted to assess the bioequivalence Albendazole Tablets IP 400 
mg (Test) of Biddle Sawyer Limited (GSK group company) compared with Albendazole Tablets 
400 mg (Reference) of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in 
Healthy, Adult Participants under Fed Condition. 
2 Objective, Endpoints and Estimands 
 
Objectives 
Endpoints 
Primary 
  
• To evaluate if Test Study Intervention 
(T): Albendazole tablets IP 400 mg, 
manufactured by Biddle Sawyer 
Limited is bioequivalent to Reference 
Study Intervention (R): Albendazole 
Tablets 400 mg, manufactured by GSK 
Consumer Healthcare, South Africa 
(PTY) 
• Albendazole Cmax and AUC(0-t) 
Secondary 
  
• To assess secondary pharmacokinetic 
parameters of Test Study Intervention 
(T): Albendazole tablets IP 400 mg 
relative to Reference Study 
Intervention (R): Albendazole tablets 
400 mg. 
• Albendazole AUC0-∞, Tmax, t1/2, 
lambda-z (λz) and 
AUC_%Extrap_obs. 
• Albendazole sulfoxide Cmax, 
AUC(0-t), AUC0-∞, Tmax, t1/2, 
lambda-z (λz) and 
AUC_%Extrap_obs. 
• To assess the safety and tolerability of 
a single oral dose of the test versus the 
reference study intervention. 
• Incidence of AE. 
• Absolute and change from baseline 
in vital signs parameters at each 
timepoint. 
 
 Primary estimand/coprimary estimands: 
 
The primary clinical question of interest is: 
To evaluate if Test Study Intervention (T): Albendazole tablets IP 400 mg is bioequivalent to   
Reference Study Intervention (R) Albendazole tablets 400 mg in healthy adult participants under 
fed conditions. 
The estimand is described by the following attributes: 


 
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   •  Population: Healthy adult participants between 18 to 45 years of age. 
  • Treatment condition: Single dose of Albendazole tablets IP 400 or Albendazole tablets 400 
mg, each treatment period given under fed conditions to healthy participants. 
          • Variable/endpoint: Cmax and AUC(0-t) 
          • Summary measure: 
      o Treatment ratios of geometric least square means with 90% CI, and within-subject 
              coefficient of variation of reference study intervention (intra-subject CV in %). 
       • Intercurrent events: 
o Permanent Treatment discontinuation due to any reason (includes COVID-19 positive, AE     
related withdrawal etc.) – While-on treatment strategy that is, all available data up until the 
withdrawal of the consent will be reported. 
o Use of prohibited or rescue medication which could affect PK parameters (Cmax and 
AUC(0-t)) during the study – Hypothetical strategy  
o Experiences emesis/vomiting before 2 times of median Tmax (i.e. 2 x 2hour = 4hour) after   
    dose administration – Hypothetical strategy. 
           • Rationale for estimand: 
o The rationale of the while on treatment strategy is to estimate the PK parameters 
                when participants have taken the dose/treatment condition. 
o The rationale of hypothetical strategy for prohibited/rescue medication is to minimize the 
potential confounding of PK data (Cmax and AUC(0-t)). It attempts to estimate treatment 
effects had the intercurrent event not occurred. In this scenario, if the intercurrent event 
occurred before 2 times median Tmax (i.e. 2 x 2hour = 4hour) after study drug 
administration, PK parameters (Cmax and AUC (0- t)) data would be set to be missing for 
that period. 
o Hypothetical strategy would be considered if emesis/vomits occur before 2 times the median      
Tmax (i.e., 2 x 2hour = 4hour) after study drug administration in particular period, this is 
because the drug would not have been absorbed into the body. In this situation, PK 
parameters (Cmax and AUC(0-t)) data would set to be missing for that period. 
 
Secondary estimand(s) - PK endpoint 
 
       The secondary clinical question of interest is: 
       To assess secondary pharmacokinetic parameters of Test Study Investigation (T): Albendazole 
tablets IP 400 mg relative to Reference Study Investigation (R): Albendazole tablets 400 mg. 
 
     The estimand is described by the following attributes: 
 
   • Population: Healthy adult participants between 18 to 45 years of age. 
 
  •Treatment condition: Single dose of Albendazole tablets IP 400 mg or Albendazole tablets 
400 mg, each treatment period given under fed conditions to healthy participants. 
 
   Variable/endpoint: 
 
           • Albendazole AUC0-∞, Tmax, t1/2, λz and AUC_%Extrap_obs. 
 
           • Albendazole sulfoxide Cmax, AUC(0-t), AUC0-∞, Tmax, t1/2, λz and AUC_%Extrap_obs. 


 
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     Summary measure: 
 
       Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, SD, median, minimum, 
maximum, and geometric mean) will be presented for untransformed secondary PK parameters 
(AUC0-∞, AUC(0-t), Tmax, t1/2, λz and AUC_%Extrap_obs). 
 
          • Intercurrent events: 
 
      o Same as primary endpoint 
 
          • Rationale for estimand: 
      o The rationale of hypothetical strategy which is impacted to secondary PK parameters 
(AUC0-∞, AUC(0-t), Tmax, t1/2, λz and AUC_%Extrap_obs) during the study is same as 
primary estimands. 
 
  Secondary estimand(s) - 2(Safety) 
 
  The secondary clinical question of interest is: 
To assess the safety and tolerability of a single oral dose of Test Study Intervention (T): 
Albendazole tablets IP 400 mg relative to Reference Study Intervention (R): Albendazole tablets 
400 mg. 
 
    The estimand is described by the following attributes: 
 
         • Population: Healthy adult participants between 18 to 45 years of age. 
 
           • Treatment condition: Single dose of Albendazole tablets IP 400 mg or Albendazole tablets 
400 mg, each treatment period given under fed conditions for healthy participants. 
 
           • Variable/endpoint: Incidence of AE and Absolute and change from baseline in vital signs 
parameters at each timepoint. 
 
           • Summary measure: 
   o Number and percentage will be presented for incidence of AE. 
 
      o Descriptive statistics (N, n, mean, SD, median, minimum, and maximum) will be presented 
for absolute and change from baseline values of vital signs parameters at each timepoint. 
 
         • Intercurrent events: 
Permanent Treatment discontinuation due to any reason (includes COVID-19 positive, AE   
related withdrawal etc.) – Treatment policy strategy. 
 
        • Rationale for estimand: 
         Permanent Treatment discontinuation due to any reason will be handled with a treatment  
policy strategy as occurrence of AE until participant are on study will be collected and 
reported. 
 


 
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3 Overall Study Design 
3.1 Study Design 
An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single 
Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of 
Biddle Sawyer Limited (GSK group company) with Albendazole Tablets 400 mg of GSK 
Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants under Fed 
Condition. 
Based on Error! Reference source not found., this study will employ 2 sequences in a 4-period 
cross-over design, i.e. T-R-T-R and R-T-R-T (T=test study intervention, R=reference study 
intervention).  
 
Study design overview 
 
3.2 Study Intervention(s) Administered 
 
Intervention Label 
Test (T) 
Reference (R) 
Intervention Name 
Albendazole tablets IP 
400 mg 
Albendazole 400 mg tablets 
Intervention Description 
Solid dosage form 
Solid dosage form  
Type  
Drug 
Drug 
Dose Formulation 
Tablet 
Tablet 
Unit Dose Strength(s) 
400 mg 
400 mg 
Dosage Level(s) 
single oral dose of 400 mg 
single oral dose of 400 mg 
Route of Administration 
oral 
oral 
Use 
active comparator 
active comparator 
IMP and NIMP/AxMP. 
Study intervention 
Study intervention 
Sourcing 
Provided by the sponsor  
Provided by the sponsor 
Packaging and Labeling 
Study intervention will be 
provided in container. Each 
container will be labeled as 
required 
per 
country 
requirement. 
Study intervention will be 
provided in container. Each 
container will be labeled as 
required 
per 
country 
requirement. 
Period 
I
Period 
II
Period 
III
Period 
IV
Subject
Randomiz
ation
Sequen
ce 1
Test
Refere
nce
Test
Refere
nce
End of Study 
(EOS)
Sequen
ce 2
Refere
nce
Test
Refere
nce
Test
Washout
Washout
Washout


 
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3.3 Sample Size 
Based on the WHO guideline for albendazole, the maximum intra-subject variability observed 
for primary pharmacokinetic parameters Cmax and AUC(0-t) could be up to ~ 68% and 62% 
respectively. For this sample size calculation, a product difference of up to 10% (i.e. T/R ratio as 
90.0-111.1%) has been assumed. 
 
The sample size was determined using R software considering the following assumptions: 
a. T/R ratio = 90.0-111.1%  
b. Intra-Subject CV (%) ~ 68% (Cmax) and 62% (AUC(0-t)), or 48% (both)  
c. Significance Level = 5% 
 
Correlation between Cmax and AUC(0-t) was calculated to be very high, based on an in-house 
albendazole study (GSK study O7921353). The exact Cmax and AUC(0-t) covariance matrix was 
calculated from this historical study as per below table and used to simulate realistic Cmax and 
AUC(0-t) values based on multivariate normal distributions. These values were then used to 
perform joint power calculation on the basis of inclusion of 70 participants with varying levels of 
missing data. To determine the power, success rates were based on 1000 replicates of the study 
design. 
Table 1 Covariance matrix used for Cmax and AUC(0-t) in power calculations 
 
AUC(0-t) 
Cmax 
AUC0-t 
0.814 
0.685 
Cmax 
0.685 
0.747 
 
Table 2 Joint power calculation results (N=1000) across various scenarios of missing data 
Scenario 
Joint Power (CV% = 48% 
for 
both 
Cmax 
and 
AUC(0-t))  
Joint Power (CV% = 68% 
and 62% for AUC(0-t) and 
Cmax respectively) 
48 participants have complete 
data for Cmax and AUC(0-t) for 
all 4 periods and 22 Participants 
data is completely missing 
90.3% 
93.7% 
48 participants have complete 
data for Cmax and AUC(0-t) for 
all 4 periods, 10 participants 
have 2 period data and 12 
participants data is completely 
missing  
93.4% 
95.8% 
48 participants have complete 
data for Cmax and AUC(0-t) 
for all 4 periods, 6 participants 
have data for 2 periods and 16 
remaining participants have no 
data at all 
91.5% 
94.9% 
 
Based on these results, and the aforementioned covariance matrix, at least 48 participants would 
be required to power a study to 90% to establish bioequivalence under the assumptions 


 
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highlighted above. Based on experience, ~30% dropouts and/or withdrawals (due to unavoidable 
reasons like medical ground, adverse events, own accord, etc.) should be considered, requiring a 
target inclusion of 70 participants for this study. In-house data showed the variance of Cmax and 
AUC to be closer to 48%, implying that the above sample size calculation takes into account the 
worst-case scenario, and may in fact provide a power of > 95%. 
Sufficient number of volunteers will be asked to report on the day of check-in of period I in order 
to ensure that at least 70 participants will be enrolled in the beginning of the study. Subsequent 
dropouts after dosing in period I will not be replaced. 
Note: Additional participants if available, may be checked-in on the day of check in of period I 
to compensate for any dropout prior to dosing of period I. These participants will be dosed if there 
are dropouts prior to dosing in period I. If there are no dropouts, these participants will be 
checked-out without being dosed after completion of dosing in period I. 
3.4 Randomization  
Participants will be assigned either of the two sequence 'TRTR' or 'RTRT' based on the 
randomization schedule by Lambda generated using SAS® Version 9.4 or higher (SAS Institute 
Inc., USA). Equal allocation of participants in each sequence is planned. 
The personnel involved in dispensing of study intervention and verification of dispensed study 
interventions will be accountable for ensuring compliance to randomization schedule. 
3.5 PK Sampling Schedule  
A total of 22 blood samples each of 3 mL, will be collected from each participant in each period. 
The venous blood samples will be withdrawn at the following times. All actual sample times will 
be recorded in addition to their planned time. 
Day 
Time points 
(Hours) 
Proposed clock time  
 
Analytes to measure 
Albendazole 
Albendazole 
Sulfoxide  
1 
 
Pre-dose 
(0.00) 
Within 60 minutes 
prior to dosing 
√ 
√ 
0.33 
0h20min 
√ 
√ 
0.67 
0h40min 
√ 
√ 
1.00 
1h00min 
√ 
√ 
1.33 
1h20min 
√ 
√ 
1.67 
1h40min 
√ 
√ 
2.00 
2h00min 
√ 
√ 
2.33 
2h20min 
√ 
√ 
2.67 
2h40min 
√ 
√ 
3.00 
3h00min 
√ 
√ 
3.33 
3h20min 
√ 
√ 
3.67 
3h40min 
√ 
√ 
4.00 
4h00min 
√ 
√ 


 
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Day 
Time points 
(Hours) 
Proposed clock time  
 
Analytes to measure 
Albendazole 
Albendazole 
Sulfoxide  
4.50 
4h30min 
√ 
√ 
5.00 
5h00min 
√ 
√ 
6.00 
6h00min 
√ 
√ 
8.00 
8h00min 
√ 
√ 
10.00 
10h00min 
√ 
√ 
12.00 
12h00min 
√ 
√ 
14.00 
14h00min 
√ 
√ 
2 
18.00 
18h00min 
√ 
√ 
24.00 
24h00min 
√ 
√ 
Day 1: Day of study intervention administration in each period.  
Day 2: Subsequent day after study intervention administration in each period. 
 
4 Analysis sets 
The analysis set will be defined as follows: 
Analysis 
Sets  
Description  
Analysis Evaluate 
Randomized  All participants assigned to study treatment  
Study Population 
Safety set  
The safety set will include all randomized participants 
who receive at least 1 dose of study medication. The 
safety population will be used for all analyses of 
safety data.  
Safety 
PK set  
All participants in the Safety set who had at least 1 
measurable PK assessment (for the purpose of the PK 
analysis, only those participants in this dataset who 
have evaluable data for one test and one reference 
period will be used). 
PK 
 
5 Assessment of Pharmacokinetic Parameters 
5.1 Pharmacokinetic analysis  
Pharmacokinetic analysis will be performed on the available concentration data of all the 
participants.  
 
Criteria for exclusion of pharmacokinetic parameters of particular participants from statistical 
analysis will be as below:  
 
Participants who were discontinued/withdrawn and do not have evaluable data for at least 1 
treatment and 1 reference drug period will be excluded.  


 
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Three consecutive missing (M) / Non-Reportable (NR) samples in elimination phase may 
significantly influence the AUC(0-t) and elimination phase dependent parameters (AUC0-∞, 
AUC0-t, t1/2, λz, AUC_%Extrap_obs). Inclusion of such parameters in the statistical analysis may 
mislead the final outcome. Hence, AUC(0-t) and elimination phase dependent parameters   
(AUC0-∞, AUC(0-t), t1/2, λz, AUC_%Extrap_obs) will be excluded. 
 
The concentration–time profiles of subjects who exhibit pre-dose concentrations higher than 5% 
of the corresponding Cmax of that period will be excluded from the statistical analysis [Note: a 
statistical sensitivity analysis including the same will be provided for information purpose]. 
 
Participants without measurable concentrations or who have only very low plasma concentrations 
relative to that of the product in question, will be excluded from the pharmacokinetic and statistical 
analyses. A participant is considered to have very low plasma concentrations if their AUC is less 
than 5% of the geometric mean AUC of the product in question, calculated without inclusion of 
data from the outlying participant [Note: statistical analysis with including the same will be 
provided for information purpose]. 
 
Note: This exclusion will be period specific. 
5.2 Pharmacokinetic Parameters 
The following pharmacokinetic parameters will be computed for albendazole and albendazole 
sulfoxide using non-compartmental model of Phoenix® WinNonlin® Version 8.3 or higher 
(Certara L.P.) for each period: 
• Primary Pharmacokinetic Parameters: Cmax, AUC0-t  
• Secondary Pharmacokinetic Parameters: AUC0-, Tmax, z, t1/2, AUC_%Extrap_obs 
Primary PK Parameters: 
Cmax 
: Maximum measured plasma concentration. 
AUC(0-t) 
: Area under the plasma concentration versus time curve from time zero 
to the last measurable concentration as calculated by linear trapezoidal 
method. 
Secondary PK Parameters 
AUC0- 
: Area under the plasma concentration versus time curve from time 
zero to time infinity. Where AUC0- = AUC(0-t) + Ct/z, Ct is the 
last measurable concentration and z is the terminal rate constant. 
Tmax 
: Time of the maximum measured plasma concentration.  
z 
: First order rate constant associated with the terminal (log-linear) 
portion of the curve. This is estimated via linear regression of time 
vs. log concentration. 
This parameter will be calculated by linear least squares regression 
analysis using at least last 3 non-zero plasma concentration values. 
t1/2 
: The terminal half-life will be calculated as 0.693/z. 
AUC_%Extrap_obs : The residual area in percentage will be determined by the formula, 
[(AUC0- - AUC0-t)/AUC0-] x 100. 
For all the above computations, actual time points of the sample collection will be used. 


 
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Non-quantifiable (NQ) data, such as concentrations below the quantification limit may be 
excluded or omitted, depending on where they are located in time, see Section 6.3.2.6. 
No value of λz, AUC0-, AUC_%Extrap_obs and t1/2 will be reported for cases that do not exhibit 
a terminal log-linear phase in the concentration versus time profile. 
6 Statistical Considerations  
6.1 
Statistical Hypotheses  
According to WHO product specific guidance (Notes on the Design of Bioequivalence Study: 
Albendazole; 29 March 2021), albendazole pharmacokinetics in the fed state is highly variable 
(up to 68% for Cmax and 62% for AUC). Therefore, this study was designed as a replicate cross-
over study, to estimate variability more accurately and, if indicated, to widen the acceptance range 
for Cmax and AUC(0-t) (Error! Reference source not found., 2021). Considering the same, full 
replicate study has been planned in line with WHO product specific guidance document and 
reference-scaled average bioequivalence approach will be used for hypothesis testing.  
 
The null hypothesis to be tested is: 
 
𝐻0:
(μ𝑇−𝜇𝑅)
2
𝜎𝑊𝑅
2
≥ 𝜃  
 
Versus alternative hypothesis 
 
𝐻1:
(μ𝑇−𝜇𝑅)
2
𝜎𝑊𝑅
2
<  𝜃  
 
Where: μ𝑇 and 𝜇𝑅 are the means of ln-transformed PK parameters (Cmax and/or AUC) obtained 
from the BE study for the test and reference products, respectively.  
𝜎𝑊𝑅 is the within-subject standard deviation of the ln-transformed values of PK parameter of 
the reference study intervention. 
Testing will be performed at a level of 0.05 and 𝜃 is the scaled average BE limit. 
The test drug must pass for primary endpoint PK parameters (Cmax and AUC(0-t)) to 
demonstrate BE to the reference drug. Let σW 0 be the regulatory constant (based on 0.80-1.25 
geometric mean ratio restriction criteria) and assumed to be 0.294.  
a. The 90% confidence interval of GMR of T/R must be contained within [U, L] = exp [±k·sWR], 
which is scale acceptance limit based on k(θS),  
Where k = ln(1.25)/σW 0 which is approx. 0.760 
U is the upper limit of the acceptance range, L is the lower limit of the acceptance range, 
sWR is the within-subject standard deviation of the ln-transformed values of PK parameter 
of the reference study intervention.  
b. Point estimate of GMR of T/R should be between 80.00 –125.00%. 
For the parameters Cmax and AUC(0-t), if the intra-subject CVW of for the reference study 
intervention is less than or equal to 0.30 upon trial completion for any of these treatment group, 
conventional average BE approach with TOST procedure with α=0.05 for each one-sided test will 


 
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be used to test 0.8 ≤ GMR ≤ 1.25. This is equivalent to requiring that a 90% interval for the true 
ratio of test to reference geometric means falls entirely within the range of 80.00 to 125.00%. If 
the intra-subject coefficient of variation (CVW) of for the reference study intervention is greater 
than 0.30 upon trial completion, a reference-scaled average bioequivalence approach will be 
used3.  
If the intra-subject variability for Cmax and AUC(0-t) following replicate administrations of the 
comparator product is > 30%, the acceptance criteria for Cmax and AUC(0-t) will be widened to 
a maximum of 69.84–143.19%. 
6.2 
Multiplicity Adjustment 
No multiplicity adjustment is required for this bioequivalence study. 
6.3 
Statistical Analysis 
6.3.1 
General considerations 
 
The pharmacokinetic parameters will be analyzed to evaluate the differences between the test and 
reference study interventions by applying referenced scaled average bioequivalence approach. 
This approach will be assessed based on GMR and 90% confidence interval for ln-transformed 
PK parameters Cmax and AUCt using RSABE. 
 
All the statistical analysis will be performed using SAS® Version 9.4 or higher (SAS Institute Inc., 
USA). 
The participants having pharmacokinetic parameters available for 2 reference treatments will be 
included for calculation of intra-subject variability of reference study intervention. 
 
Descriptive statistics & average bioequivalence analysis will be performed on the participants 
having pharmacokinetic parameters available for at least 1 test and 1 reference arm. 
6.3.2 
Primary Endpoint(s)/Estimand(s) Analysis 
6.3.2.1 
Descriptive statistics 
 
Statistical analysis for primary endpoints will include descriptive statistics for the following 
pharmacokinetic parameters:  
 
Cmax and AUC(0-t) 
 
Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, geometric mean, 95% 
CI of geometric mean, SD, median, minimum and maximum) will be presented for primary PK 
parameters. 
 
Average values of Test Study Intervention-T and Reference Study Intervention-R for PK 
parameters for each participant will be calculated and reported. Descriptive statistics will be 
calculated and reported for the same data.  
 
Individual values of PK parameters for Test Study Intervention-T (first administration), Test Study 
Intervention-T (second administration), Reference Study Intervention-R (first administration) and 
Reference Study Intervention-R (second administration) for each participant will be calculated 
and reported. Descriptive statistics will be calculated and reported for the same data. 
 


 
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PK parameters will be analyzed to evaluate the differences between the test and reference products 
by applying SCABE following EMA guidelines in investigation of bioequivalence regarding 
highly variable drug product (% of CVw >30), otherwise ABE will be applied. 
6.3.2.2 
Analysis of Variance (ANOVA) 
Analysis of Variance (ANOVA) will be used on ln-transformed pharmacokinetic parameters Cmax 
and AUC(0-t) for albendazole or albendazole sulfoxide. The ANOVA model will include sequence, 
participant(sequence), period and formulation as fixed effects.  
Each analysis of variance will include calculation of ratio of geometric least-squares means and the 
standard error associated with these ratios.  
The above statistical analyses will be done using PROC GLM of SAS® procedure. A significance 
level of 5% (alpha =0.05) will be used for the model. 
6.3.2.3 
90% Confidence Interval 
90% confidence intervals for the ratio of geometric least squares means between drug formulations 
will be calculated for ln-transformed data of Cmax and AUC(0-t) for albendazole and albendazole 
sulfoxide. 
6.3.2.4  
Ratio analysis 
Ratio of geometric least squares means of test and reference formulations will be computed and 
reported for ln-transformed pharmacokinetic parameters Cmax and AUC(0-t) for albendazole and 
albendazole sulfoxide. 
6.3.2.5 
Intra-subject variability 
Intra-subject variability of reference study intervention-R will be computed and reported for ln-
transformed pharmacokinetic parameters Cmax and AUC(0-t) for albendazole and albendazole 
sulfoxide. 
The existence of outlier subjects that inflate the intra-subject variability will be assessed. In case of 
such outliers, results will be reported with and without those outliers. 
6.3.2.6 
Missing and non-reportable values 
If 1 or more NQ values occur in a profile before the first measurable concentration, they will be 
assigned a value of zero concentration. 
If a single NQ value occurs between measurable concentrations in a profile, the NQ should be 
omitted (set to missing) in the derivation of pharmacokinetic parameters and statistical analysis. 
If 2 or more NQ values occur in succession between measurable concentrations, the values in 
question will be set to missing. For the derivation of pharmacokinetic parameters, these NQs will 
be omitted. The NQ values will be set to 0 and the trapezoidal rule will be applied to all the observed 
data.  
NQs which occur after the last measurable concentration will be omitted (set to missing) in the 
derivation of pharmacokinetic parameters and statistical analysis. Any missing samples (M) 
concentration value will be disregarded in pharmacokinetic and statistical analysis. 
6.3.2.7  
Intercurrent event and handling of missing data 
The data will be affected by occurrence of the intercurrent event and only data available while the 
participant is receiving the treatment will be used under while-on treatment policy strategy. 
Participant level missing data will not be imputed, and available data will be used in the analysis. 


 
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In the case of emesis/vomiting or use of prohibited/rescue medication, the data for that period will 
not be used for the analysis of PK parameters relating to the primary endpoint using hypothetical 
strategy. 
6.3.2.8 
Bioequivalence criteria 
Based on the statistical results of 90% confidence interval for the ratio of the geometric least square 
means for both ln-transformed pharmacokinetic parameters Cmax and AUC(0-t), conclusion will 
be drawn for Test Study Intervention-T vs. Reference Study Intervention-R for albendazole with 
following considerations. 
For Cmax and AUC(0-t):  
1. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) ≤ 30% then 
bioequivalence of the test study intervention with that of the reference study intervention will be 
concluded, if the 90% confidence interval falls within the acceptance range of 80.00–125.00% for 
ln-transformed pharmacokinetic parameter Cmax and AUC(0-t). 
2. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) > 30% then Cmax 
and/or AUC(0-t) limit will be widened using scaled-average-bioequivalence. Under scaled-
average-bioequivalence, [U,L] = exp [±k· SWR] where U is the upper limit of the acceptance range, 
L is the lower limit of the acceptance range, k is the regulatory constant set to 0.760 and SWR is the 
within-subject standard deviation of the ln transformed values of Cmax and/or AUC(0-t) of the 
reference study intervention. 
3. If within-reference intra-subject CV of ln-transformed Cmax and/or AUC(0-t) ≥ 50% then Cmax 
and/or AUC(0-t) bioequivalence limits will be widened to a maximum of 69.84 – 143.19%.  
Bioequivalence of the test study intervention with that of the reference study intervention will 
be concluded for Cmax and AUC(0-t), if both of the following conditions are satisfied: 
• The 90% confidence interval for ln-transformed data of Cmax and AUC(0-t) falls within 
the respective newly widen range [U, L] = exp [±k· SWR], which is based upon the within-
subject variability observed for respective pharmacokinetic parameter.  
• The geometric least square mean ratio (GMR) of test to reference for Cmax and AUC(0-t) 
falls within the acceptance range of 80.00– 125.00%. 
Data of metabolite albendazole sulfoxide will be provided as supportive information only. 
6.3.3 
Secondary Endpoint(s)/Estimand(s) Analysis 
Statistical analysis for secondary endpoints will include descriptive statistics for the following 
pharmacokinetic parameters: 
  Albendazole: AUC0-∞, Tmax, t1/2, λz and AUC_%Extrap_obs 
  Albendazole sulfoxide: AUC0-∞, AUC0-t, Cmax, Tmax, t1/2, λz and AUC_%Extrap_obs. 
Descriptive statistics (N, n, arithmetic mean, 95% CI of arithmetic mean, SD, median, minimum, 
maximum and geometric mean with 95% CI) will be presented for untransformed secondary PK 
parameters. 
Average values of Test Study Intervention-T and Reference Study Intervention-R for PK   
parameters for each participant will be calculated and reported. Descriptive statistics will be 
calculated and reported for the same data.  


 
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Individual values of PK parameters for Test Study Intervention-T (first administration), Test   Study 
Intervention-T (second administration), Reference Study Intervention-R (first administration) and 
Reference Study Intervention-R (second administration) for each participant will be calculated and 
reported. Descriptive statistics will be calculated and reported for the same data. 
In case of treatment discontinuation due to any reason, only the data available before the       
occurrence of intercurrent event will be used to estimate secondary PK parameters using while-on-
treatment policy strategy. 
If any participant experience emesis/vomiting or if a prohibited/rescue medication is used by any 
participant, the participant’s data for that period will not be used for the analysis of secondary 
endpoints related to PK using hypothetical strategy. 
Treatment policy strategy will be used to analyze the secondary endpoints related to safety to make 
use of all available data for a participant.  
7 Safety Assessment and Analysis  
7.1 Safety Assessment 
 
Demographic data  
Demographic data such as date of birth, sex, race, age, and ethnicity will be assessed on screening 
visit. 
 
Body Measurement 
Body measurement data such as height, weight and BMI will be assessed on screening visit. 
 
Medication history  
Current medication (prescribed medication & OTC medication, herbal remedies, cimetidine, 
praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) and usage of 
any concomitant therapy or any ingestion of medicine in the previous 14 days prior to dosing of 
period I and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing of period I.  
Medication history will be recorded on PERIOD 1 (Day 1) 
 
Physical examination  
Physical examination will be assessed on screening visit, check in (Day 1) and check-out (Day 2) 
of each period.  
 
Urine drug scan and breath alcohol test 
Drug abuse in urine and Breath alcohol test will be performed on check-in of each period.  
 
Chest X-ray  
Chest X-ray (within the last 6 months) (postero-anterior view) will be carried out at the time of 
screening.  
 
Vital signs  
Vitals (sitting blood pressure and radial pulse) will be recorded at pre-dose (within 60 minutes 
before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period.  
Note: All post-dose vitals will be performed within ± 40 minutes of the scheduled time.  
 
Recording of vital signs (blood pressure, respiratory rate and radial pulse and body temperature) 
will be done at screening, after check-in, before check-out in each period. 


 
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Note: Vital signs before checkout may be started 120 minutes prior to the scheduled time of check-
out of each participant.  
 
 
12-lead ECG  
12-lead ECG will be carried out at the time of screening (up to 28 days before Dosing in period I). 
 
Clinical safety laboratory tests  
Serology tests (HIV AB (1 & 2), Anti HCV and HBsAg) will be performed at the time of screening.  
Urine parameters will be performed at the time of screening. 
Urine parameters: Specific Gravity, Leucocytes, Bilirubin, Urobilinogen, Erythrocytes, pH, 
Protein, Ketones, Glucose, Nitrite, Microscopic examination (As applicable). 
 
Laboratory assessment for hematology and biochemistry will be performed at the time of 
screening. Laboratory assessment for hematology and biochemistry (except random glucose, 
sodium, potassium, chloride, alkaline phosphatase) will be performed at the end of the study (at 
the time of check-out of period IV).  
Laboratory assessment for liver function test (SGPT, SGOP and total bilirubin) will be performed 
prior to check-in of period II, III and IV.  
Hematology: Hemoglobin [Hb], RBC count, HCT, MCV, MCH, MCHC, RDW CV, Platelet count, 
WBC (total), Neutrophils %, Lymphocytes %, Eosinophils %, Monocytes %, Basophils %, 
Neutrophils abs, Eosinophils abs 
Biochemistry: Random Glucose, Bilirubin Total, Total Protein, Albumin, Serum Globulin, A/G 
ratio, SGOT (AST), SGPT (ALT), Creatinine, Blood Urea Nitrogen, Sodium, Potassium, Chloride, 
Alkaline phosphatase. 
 
Pregnancy testing  
Serum Pregnancy test for female participants will be done at the time of screening, prior to check-
in of each period and at the end of the study (at the time of check-out of period IV). Pregnancy 
testing must be done even if the participant is menstruating at the time of the study visit. The study 
intervention may only be administered if the pregnancy test is negative.  
7.2 
Safety Analysis 
Safety analysis will be done on the safety set. Safety variables include AEs, clinical laboratory 
parameters, vital signs, physical examinations. Safety variables will be listed and summarized with 
descriptive statistics as appropriate. 
 Continuous variables will be Summarized by treatment/sequence group using summary statistics 
(number of observations, mean, standard deviation, median, minimum and maximum etc.) as 
applicable. Categorical values will be summarized by the treatment group using frequencies and 
percentages.  
Result obtained when evaluating safety (adverse events, vital signs, clinical laboratory tests etc.) 
will be listed and evaluated descriptively. 
Adverse events  
All AEs reported during the study must be included in the safety analysis. AEs will be classified 
by system organ class, by preferred term from the MedDRA version 25.0 or higher. They will be 
presented in individual listings and summary tables, and evaluated descriptively and in terms of 


 
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frequencies, by treatment. As will be summarized for all subjects in Safety set across two treatment 
groups by System Organ Class (SOC) and Preferred Term (PT). p-value using chi-square test or 
fisher exact test will be provided for the AE data. 
Intensity refers to the severity of the AE.: Mild, Moderate, Severe. 
Clinical laboratory values  
Clinical laboratory values will be compared to their reference ranges. Values outside the normal 
ranges will be highlighted. The Investigator has to comment, whether the abnormality is clinically 
relevant.  
Other safety parameters  
All results of vital sign measurements will be presented in individual listings. Where appropriate, 
results and possible changes in parameters will be evaluated descriptively or by descriptive 
statistics (mean, SD, median, range). Descriptive statistics (N, n, mean, SD, median, minimum and 
maximum) will be presented for absolute and change from baseline values of vital signs parameters 
at each timepoint. 
Demographic data will be shown in tables as mean values, SD and ranges (min, max). 
Clinical laboratory data will be shown in tables as mean values, SD and ranges (min, max) as 
applicable. 
Physical examination, 12 lead ECG, Chest X-Ray performance and concomitant medication will 
be presented in data listings. 
Protocol deviations 
A list of all protocol deviations and an assessment of their impact will be included in listing. The 
deviations will include dosing related, IMP related, lab related, early, late or missed safety 
assessments, etc. 
A number of participants with minor and major deviations will be provided. 
 
8 Change from the protocol 
“The ANOVA model will include sequence, participant(sequence), period and formulation as fixed 
effects” as per the WHO requirements.  
 
9 Interim analysis 
No interim analysis has been planned in this study.  
10 Software Information for Analysis 
SAS® Version 9.4 or higher (SAS Institute Inc., USA) will be used for statistical and safety 
analysis. 
Phoenix® WinNonlin® Version 8.3 or higher (Certara L.P.) will be used for pharmacokinetic 
analysis. 
 
11 Format Specifications for outputs 
1. Output files of SAS procedures/Phoenix WinNonlin (statistical analyses, summary tables, 
individual data listings, etc.) will be produced as PDF files. 


 
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2. Each individual PDF file will contain the statistical analysis output, i.e. a summary table, or data 
listing grouped by treatment or/and visit, for one analysis population, and for a single type of 
analysis. 
3. The rules for grouping may vary according to the type of data (study outcome, safety), individual 
data listings, listings of derived variables, etc. and the type of output file which is produced 
(statistical analyses, summary tables, graphs). 
4. Page format will be “A4”. 
5. Each listing will be numbered in the format Page X of Y (where Y denotes total number of pages 
in that particular listing). Page number will appear in the bottom right part of the listing. 
6. For each output, ‘Lambda Therapeutic Research Ltd.’ Will appear in the Top left corner of the 
Header, ‘Confidential’ and ‘Title’ of the output will appear in the Centre of the Header and 
towards the Top right corner the ‘project number’ will be presented.  
7. The font and font size for header/footer and body of the output will be Courier New size 9 pt 
which will be generated from SAS. The font and font size for header/footer and body of the output 
will be Times New Roman 12 pt which will be generated from Phoenix WinNonlin. 
 
 


 
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12 List of Tables 
 
14.1 
Demographic data 
  14.1.1 
Demographic data and baseline characteristics (Randomized set) 
  14.1.2 
Demographic data and baseline characteristics (Safety set)  
  14.1.3 
Demographic data and baseline characteristics (PK set) 
  14.1.4 
Visit wise distribution of subjects (Randomized set) 
  14.1.5 
Visit wise distribution of subjects (Safety set) 
  14.1.6 
Visit wise distribution of subjects (PK set) 
  14.1.7 
Summary of protocol deviations 
14.2 
Pharmacokinetic data 
  14.2.1 
Plasma albendazole data  
14.2.1.1 
Summary statistics of pharmacokinetic parameters for albendazole 
14.2.1.2 
Pharmacokinetic parameters (untransformed) of albendazole for Test Product-
T and Reference Product-R 
14.2.1.3 
Individual pharmacokinetic parameters (untransformed) of albendazole for 
Test 
Product-T1 
(first 
administration), 
Test 
Product-T2 
(second 
administration), Reference Product-R1 (first administration) and Reference 
Product-R2 (second administration) 
14.2.1.4 
Pharmacokinetic parameters (untransformed) of data excluded from statistical 
analysis for albendazole (if applicable)  
14.2.1.5 
Pharmacokinetic parameters (ln-transformed) of albendazole for Test Product-
T and Reference Product-R 
14.2.1.6 
Individual pharmacokinetic parameters (ln-transformed) of albendazole for 
Test 
Product-T1 
(first 
administration), 
Test 
Product-T2 
(second 
administration), Reference Product-R1 (first administration) and Reference 
Product-R2 (second administration) 
14.2.1.7 
Plasma concentration of albendazole for Test Product-T1 (first administration) 
14.2.1.8 
Plasma concentration of albendazole for Test Product-T2 (second 
administration) 
14.2.1.9 
Plasma concentration of albendazole for Reference Product-R1 (first 
administration) 
14.2.1.10 
Plasma concentration of albendazole for Reference Product-R2 (second 
administration) 
14.2.1.11 
Plasma concentration of data excluded from statistical analysis for albendazole 
(if applicable) 
  14.2.2 
Plasma albendazole sulfoxide data  
14.2.2.1 
Summary statistics of pharmacokinetic parameters for albendazole sulfoxide 
14.2.2.2 
Pharmacokinetic parameters (untransformed) of albendazole sulfoxide for Test 
Product-T and Reference Product-R  
14.2.2.3 
Individual pharmacokinetic parameters (untransformed) of albendazole 
sulfoxide for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference 
Product-R2 (second administration) 


 
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14.2.2.4 
Pharmacokinetic parameters (untransformed) of data excluded from statistical 
analysis for albendazole sulfoxide (if applicable)  
14.2.2.5 
Pharmacokinetic parameters (ln-transformed) of albendazole sulfoxide for Test 
Product-T and Reference Product-R  
14.2.2.6 
Individual pharmacokinetic parameters (ln-transformed) of albendazole 
sulfoxide for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference 
Product-R2 (second administration) 
14.2.2.7 
Plasma concentration of albendazole sulfoxide for Test Product-T1 (first 
administration) 
14.2.2.8 
Plasma concentration of albendazole sulfoxide for Test Product-T2 (second 
administration) 
14.2.2.9 
Plasma concentration of albendazole sulfoxide for Reference Product-R1 (first 
administration) 
14.2.2.10 
Plasma concentration of albendazole sulfoxide for Reference Product-R2 
(second administration) 
14.2.2.11 
Plasma concentration of data excluded from statistical analysis for albendazole 
sulfoxide (if applicable) 
  14.2.3 
Actual time points used for pharmacokinetic evaluation  
14.3 
Safety data  
  14.3.1 
Overall summary of treatment emergent adverse events (Safety set) 
  14.3.2 
Summary of treatment emergent adverse events by system organ class and 
preferred term (Safety set) 
  14.3.3 
Summary of treatment emergent adverse events by relationship to study drug 
and system organ class and preferred term (Safety set) 
  14.3.4 
Summary of treatment emergent adverse events by severity grade and system 
organ class and preferred term (Safety set) 
  14.3.5 
Summary of subject disposition  
  14.3.6 
Summary of vital signs (Safety set) 
  14.3.7 
Summary of change from baseline for vital signs (Safety set) 
  14.3.8 
Summary of quantitative safety laboratory variables (Safety set) 
  14.3.9 
Summary of qualitative safety laboratory variables (Safety set) 
  14.3.10 
Summary of concomitant medication (Safety set) 
 
13 List of Listings 
16.2.1  
Subject disposition 
16.2.1.1 
Screen failure subjects 
16.2.1.2 
Study completion status 
16.2.1.3 
Subject distribution in analysis population 
16.2.1.4 
Inclusion - Exclusion criteria 


 
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16.2.1.5 
Inclusion criteria description 
16.2.1.6 
Exclusion criteria description 
16.2.2 
Protocol deviations  
16.2.3 
Subjects excluded from the analysis 
16.2.3.1 
Subjects excluded from the analysis (PK set) 
16.2.4 
Demographic data 
16.2.4.1 
Demographic data and baseline characteristics 
16.2.4.2 
Personal history  
16.2.4.3 
Medical and surgical history details 
16.2.4.4 
Physical examination 
16.2.4.5 
Medication history  
16.2.5 
Compliance and/or drug concentration data  
16.2.5.1 
Study drug administration  
16.2.5.2 
Compliance assessment 
16.2.5.3 
PK Sample collection  
16.2.5.4 
Concentration-time data for albendazole 
16.2.5.5 
Pharmacokinetic data for albendazole 
16.2.5.6 
Concentration-time data for albendazole sulfoxide 
16.2.5.7 
Pharmacokinetic data for albendazole sulfoxide 
16.2.7 
Adverse events (each subject) 
16.2.7.1 
Adverse events by severity, relationship to the study drug and by MedDRA term 
16.2.7.2 
Serious adverse events (if applicable)  
16.2.8 
Listing of individual laboratory measurements (by Subject) 
16.2.8.1 
Central laboratory tests 
16.2.8.2 
Safety laboratory analysis 
16.2.9 
Individual subject data listings 
16.2.9.1 
12 Lead electrocardiogram  
16.2.9.2 
Chest x-ray  
16.2.9.3 
Body measurements 
16.2.9.4 
Vital signs  
16.2.9.5 
Urine drug scan and breath alcohol test 
16.2.9.6 
Lifestyle compliance assessment 
16.2.9.7 
Subjects date of visit 
16.2.9.8 
Unscheduled visit (if applicable) 
16.2.10 
Prior - concomitant medication 
14 List of Figures 
  14.2.4 
Figures of pharmacokinetic data  


 
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14.2.4.1 
Mean plasma concentration vs. time curve for albendazole (Linear and Semi-
log Plot) 
14.2.4.2 
Combined mean plasma concentration vs. time curve for albendazole (Linear 
and Semi-log Plot) 
14.2.4.3 
Mean (± SD) plasma concentration vs. time curve for albendazole (Linear and 
Semi-log Plot) 
14.2.4.4 
Median plasma concentration vs. time curve for albendazole (Linear and 
Semi-log Plot) 
14.2.4.5 
Median (range) plasma concentration vs. time curve for albendazole (Linear 
and Semi-log Plot) 
14.2.4.6 
Summary plot of individual plasma concentration vs time for albendazole 
(Linear and Semi-log Plot) 
14.2.4.7 
Mean plasma concentration vs. time curve for albendazole sulfoxide (Linear 
and Semi-log Plot) 
14.2.4.8 
Combined mean plasma concentration vs. time curve for albendazole sulfoxide 
(Linear and Semi-log Plot) 
14.2.4.9 
Mean (± SD) plasma concentration vs. time curve for albendazole sulfoxide 
(Linear and Semi-log Plot) 
14.2.4.10 
Median plasma concentration vs. time curve for albendazole sulfoxide (Linear 
and Semi-log Plot) 
14.2.4.11 
Median (range) plasma concentration vs. time curve for albendazole sulfoxide 
(Linear and Semi-log Plot) 
14.2.4.12 
Summary plot of individual plasma concentration vs time for albendazole 
sulfoxide (Linear and Semi-log Plot) 
16.2.6 
Individual pharmacokinetic response data 
16.2.6.1 
Individual plasma concentration vs. time curve for albendazole (Linear and Semi-
log Plot) 
16.2.6.2 
Individual plasma concentration vs. time curve for albendazole sulfoxide (Linear 
and Semi-log Plot) 
 
15 List of In-text Tables 
1 
Summary of Adverse Events 
2 
Summary of Adverse Events with System Organ Class 
 
16 Statistical Outputs 
16.1.9  
Documentation of statistical methods 
16.1.9.1 
Raw SAS output of intra-subject variability and SWR of Reference formulation 
for albendazole  
16.1.9.2 
Raw SAS output of ANOVA and BE for albendazole  
16.1.9.3 
Raw SAS output of intra-subject variability and SWR of Reference formulation 
for albendazole sulfoxide 
16.1.9.4 
Raw SAS output of ANOVA and BE for albendazole sulfoxide 
16.1.9.5 
Statistical Analysis Plan 
 
Note: Numbering in outputs may change depending on the inclusion/exclusion of the subjects considered for statistical 
analysis.  


 
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17 References 
1. ICH Harmonized Tripartite Guideline – Statistical Principles for Clinical Trials (E9). Step 5 
September 1998. 
2. ICH Harmonized Tripartite Guideline – Structure and Content of Clinical Study Reports (E3). 
Step 5 July 1996. 
3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fifth report 
(TR1033), annex 6: Multisource (generic) pharmaceutical products: guidelines on 
registeration requirements to establish interchangeability. World Health Organisation. 25 
March 2021 


 
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18 Tables and Listings shells 
14.1 Demographic Data 
14.1.1 Demographic data and baseline characteristics (Randomized set) 
 
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Table No. 14.1.1 
 
Demographic data and baseline characteristics (Randomized set) 
 
Statistics 
TRTR 
(N=xx) 
RTRT 
(N=xx) 
Total 
(N=xx) 
p-value 
Age (years) 
n 
xx 
xx 
xx 
x.xxxx 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Gender 
 
 
 
 
- 
  Male 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Female 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
Race 
 
 
 
 
 
  Asian 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
  American Indian or Alaska Native 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  … 
 
 
 
 
 
  Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
Ethnicity 
 
 
 
 
 
  Not Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
  Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Not Reported 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Unknown 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
Height (cm) 
n 
xx 
xx 
xx 
x.xxxx 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Lambda Therapeutic Research Ltd. 
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Table No. 14.1.1 
 
Demographic data and baseline characteristics (Randomized set) 
 
Statistics 
TRTR 
(N=xx) 
RTRT 
(N=xx) 
Total 
(N=xx) 
p-value 
Weight (kg) 
n 
xx 
xx 
xx 
x.xxxx 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
BMI (kg/m²) 
n 
xx 
xx 
xx 
x.xxxx 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Note: Percentages are calculated based on the total number of subjects in each category. 
Treatment specification -> T = Test Product and R = Reference Product. 
p-value is calculated using an independent t-test. 
Reference Listings: 16.2.1.3, 16.2.4.1, 16.2.9.3 
 
Output Generated on: DDMMMYYYY hh:mm 
 
<Note: Repeat the same table as 14.1.2 for Safety set and 14.1.3 for PK set > 
 
 


 
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14.1.4 Visit wise distribution of subjects (Randomized set) 
 
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Table 14.1.4 
 
Visit wise distribution of subjects (Randomized set) 
Visits 
TRTR 
(N=xx) 
RTRT 
(N=xx) 
Total 
(N=xx) 
n (%) 
n (%) 
n (%) 
 
 
 
 
PERIOD 1 (Day-1) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
PERIOD 2 (Day-1) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
PERIOD 3 (Day-1) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
PERIOD 4 (Day-1) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Note: Percentages are calculated based on the total number of subjects in each category. 
Treatment specification -> T = Test Product and R = Reference Product. 
Reference Listing: 16.2.1.3, 16.2.9.7 
 
Output Generated on: DDMMMYYYY hh:mm 
 
<Note: Repeat the same table as 14.1.5 for Safety set and 14.1.6 for PK set.> 
 
 
 


 
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14.1.7 Summary of protocol deviations 
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Table No. 14.1.7 
 
Summary of protocol deviations 
Protocol deviation 
Type of Protocol Deviation 
Total 
Major 
Minor 
Subjects with protocol deviations 
xx 
xx 
xx 
 
 
 
 
At least one protocol deviation 
xx 
xx 
xx 
   Dosing Related 
xx 
xx 
xx 
   IMP Related 
xx 
xx 
xx 
   Lab Related 
xx 
xx 
xx 
   Others 
xx 
xx 
xx 
   . 
 
 
 
   . 
 
 
 
   . 
 
 
 
Reference Listing: 16.2.2 
Output Generated on: DDMMMYYYY hh:mm 
 
 


 
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14.2 Pharmacokinetic Data  
14.2.1 Plasma Albendazole Data 
14.2.1.1 Summary statistics of pharmacokinetic parameters for albendazole 
Lambda Therapeutic Research Ltd. 
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The SAS System Version 9.4 
Table No. 14.2.1.1 
Sponsor: GSK Research & Development 
Summary statistics of pharmacokinetic parameters for albendazole 
Albendazole Tablets IP 400 mg 
Dosing: Single Oral Dose; Condition: Fed; Population: Healthy, Adult Participants  
Measures                                 Tmax           Cmax           AUC0-t                   
  (unit)         (unit)           (unit)                     
Test Treatment-T                                                                                  
__________________                                                                                
N                                        xx             xx               xx                      
Mean                                  xx.xx         xx.xxx           xx.xxx                      
SD                                   xx.xxx        xx.xxxx          xx.xxxx                     
CV(%)                                  xx.x           xx.x             xx.x                      
Geometric Mean                        xx.xx         xx.xxx           xx.xxx                     
 
Reference Treatment-R                                                                             
_______________________                                                                           
N                                        xx             xx               xx                      
Mean                                  xx.xx         xx.xxx           xx.xxx                     
SD                                   xx.xxx        xx.xxxx          xx.xxxx                    
CV(%)                                  xx.x           xx.x             xx.x                      
Geometric Mean                        xx.xx         xx.xxx           xx.xxx                     
 
ANOVA p-value                                                                                     
______________                                                                                    
ln-transformed Sequence                   -          x.xxxx           x.xxxx                     
 Period                     -          x.xxxx           x.xxxx                      
 Formulation                -          x.xxxx           x.xxxx                      
 Participant(Sequence)      -          x.xxxx           x.xxxx                      
                       
Geometric Least Squares Means                                                                     
_______________________                                                                           
ln-transformed Test-T                     -        xxxx.xxx         xxxx.xxx                     
 Reference-R                     -        xxxx.xxx         xxxx.xxx                     
 
Ratio of Geometric Least Squares Means(%)(T/R)                                                    
______________________________________________                                                    
ln-transformed                            -           xxx.x            xxx.x                      
 
Intra subject Variability of Reference Formulation-R(%)                                           
_____________________________                                                                     
   ln-transformed                           -            xx.x             xx.x                       
  Within subject standard deviation of Reference Formulation-R (SWR)                                 
  _____________________________                                                                      
   ln-transformed                           -            xx.x             xx.x            
 
90% Confidence Interval (T Vs. R)           
_______________________________                                                              
ln-transformed Lower                     -          xxx.xx           xxx.xx                     
 Upper                     -          xxx.xx           xxx.xx                      
 Power(%)                    -           xxx.x            xxx.x           
Bioequivalence               -           YES/NO           YES/NO 
Output Generated on: DDMMMYYYY hh:mm 
<Note: Repeat the same table as 14.2.2.1 for albendazole sulfoxide >  
 


 
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14.2.1.2 Pharmacokinetic parameters (untransformed) of albendazole for Test Product-T and Reference Product-R 
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Table No. 14.2.1.2 
Pharmacokinetic parameters (untransformed) of albendazole for Test Product-T and Reference Product-R 
 
Participants 
Sequence 
Tmax (unit) 
Cmax (unit) 
AUC0-t (unit) 
AUC0-inf (unit) 
Formulation 
Formulation 
Formulation 
Formulation 
T 
R 
T 
R 
(T/R)% 
T 
R 
(T/R)% 
T 
R 
(T/R)% 
1001 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
1002 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
xx.xxx 
xx.xxx 
xx.x 
N 
xx 
xx 
xx 
xx 
- 
xx 
xx 
- 
xx 
xx 
- 
Mean 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
95% CI of arithmetic 
mean 
x.xx-
x.xx 
x.xx-
x.xx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
SD 
xx.xxx 
xx.xxx 
xx.xxxx 
xx.xxxx 
- 
xx.xxxx 
xx.xxxx 
- 
xx.xxxx 
xx.xxxx 
- 
Min 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
Median 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
Max 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
- 
xx.x 
xx.x 
- 
xx.x 
xx.x 
- 
Geometric Mean 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
xx.xxx 
xx.xxx 
- 
95% CI of geometric mean 
x.xx-
x.xx 
x.xx-
x.xx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
- 
<Note: Repeat the same table as 14.2.2.2 for albendazole sulfoxide.> 
 
 
 
 


 
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14.2.1.2 Contd 1. Pharmacokinetic parameters (untransformed) of albendazole for Test Product-T and Reference Product-R 
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Table No. 14.2.1.2 Contd. 
Pharmacokinetic parameters (untransformed) of albendazole for Test Product-T and Reference Product-R 
Participants 
Sequence 
AUC_%Extrap_obs (%) 
Lambda_z (unit) 
t1/2 (unit) 
Formulation 
Formulation 
Formulation  
T 
R 
T 
R 
T 
R 
1001 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
xx 
xx 
Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of 
arithmetic mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
SD 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
Min 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
       Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
<Note: Repeat the same table as 14.2.2.2 for albendazole sulfoxide.> 
 
 


 
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14.2.1.3 Individual Pharmacokinetic parameter (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Lambda Therapeutic Research Ltd. 
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Project No. 0110-23 
Table No. 14.2.1.3  
Individual pharmacokinetic parameters (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Participants Sequence 
Tmax (unit) 
Cmax (unit) 
AUC0-t (unit) 
Formulation 
Formulation 
Formulation 
T1 
T2 
R1 
R2 
T1 
T2 
R1 
R2 
T1 
T2 
R1 
R2 
1001 
  
xx.xx 
xx.xx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
  
xx.xx 
xx.xx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
  
xx.xx 
xx.xx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Mean 
xx.xx 
xx.xxx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of arithmetic 
mean 
x.xx-
x.xx 
x.xxx-
x.xxx 
x.xx-x.xx 
x.xx-x.xx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
SD 
xx.xxx 
xx.xxxx 
xx.xxx 
xx.xxx 
xx.xxxx 
xx.xxxx xx.xxxx xx.xxxx xx.xxxx xx.xxxx xx.xxxx xx.xxxx 
Min 
xx.xx 
xx.xxx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xx 
xx.xxx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xx 
xx.xxx 
xx.xx 
xx.xx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric 
mean 
x.xx-
x.xx 
x.xxx-
x.xxx 
x.xx-x.xx 
x.xx-x.xx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
<Note: Repeat the same table as 14.2.2.3 for albendazole sulfoxide > 
 


 
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14.2.1.3 Contd.  Individual pharmacokinetic parameter (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 
(second administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Lambda Therapeutic Research Ltd. 
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Project No. 0110-23 
Table No. 14.2.1.3 Contd. 
Individual pharmacokinetic parameters (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Participants 
Sequence 
AUC0-inf (unit) 
             AUC_%Extrap_obs (%) 
Formulation 
Formulation 
T1 
T2 
R1 
R2 
T1 
T2 
R1 
R2 
1001 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
n 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of arithmetic mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-x.xxx 
SD 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
Min 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-x.xxx 
<Note: Repeat the same table as 14.2.2.3 for albendazole sulfoxide > 
 
 
 


 
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14.2.1.3 Contd.  Individual pharmacokinetic parameter (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 
(second administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Lambda Therapeutic Research Ltd. 
Confidential 
 
Project No. 0110-23 
Table No. 14.2.1.3 Contd. 
Individual pharmacokinetic parameters (untransformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Participants 
Sequence 
Lambda_z (unit) 
 t1/2 (unit) 
Formulation 
Formulation 
T1 
T2 
R1 
R2 
T1 
T2 
R1 
R2 
1001 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
n 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of arithmetic mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-x.xxx 
SD 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
Min 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric mean 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-
x.xxx 
x.xxx-x.xxx 
<Note: Repeat the same table as 14.2.2.3 for albendazole sulfoxide > 
 
 


 
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14.2.1.4 Pharmacokinetic parameters (untransformed) of data excluded from statistical analysis for albendazole (if applicable) 
 Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
Table No. 14.2.1.4 
Pharmacokinetic parameters (untransformed) of data excluded from statistical analysis for albendazole 
 
Participants Period Sequence Formulation 
Tmax 
(unit) 
Cmax 
(unit) 
AUC0-t 
(unit) 
AUC0-inf 
(unit) 
AUC_%Extrap_obs 
(%) 
Lambda_z 
(unit) 
t1/2  
(unit) 
1001 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xx 
1002 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xx 
<Note: Repeat the same table as 14.2.2.4 for albendazole sulfoxide.> 
 
 
 
 
 
 
 
 


 
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14.2.1.5 Pharmacokinetic parameters (ln-transformed) of albendazole for Test Product-T and Reference Product-R 
Lambda Therapeutic Research Ltd. 
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Table No. 14.2.1.5 
Pharmacokinetic parameters (ln-transformed) of albendazole for Test Product-T and Reference Product-R 
Participants 
Sequence 
Cmax 
AUC0-t 
Formulation 
Formulation 
T 
R 
T 
R 
1001 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of arithmetic mean 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
SD 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
Min 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric mean 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
<Note: Repeat the same table as 14.2.2.5 for albendazole sulfoxide.> 
 
 


 
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14.2.1.6 Individual Pharmacokinetic parameter (ln-transformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Lambda Therapeutic Research Ltd. 
 Confidential 
Project No. 0110-23 
Table No. 14.2.1.6 
Individual pharmacokinetic parameters (ln-transformed) of albendazole for Test Product-T1 (first administration), Test Product-T2 (second 
administration), Reference Product-R1 (first administration) and Reference Product-R2 (second administration) 
Participants 
Sequence 
Cmax (unit) 
AUC0-t (unit) 
Formulation 
Formulation 
T1 
T2 
R1 
R2 
T1 
T2 
R1 
R2 
1001 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
1002 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
. 
  
. 
. 
. 
. 
. 
. 
. 
. 
n 
  
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
N 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of arithmetic mean 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
SD 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
xx.xxxx 
Min 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Median 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
Max 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
CV% 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
Geometric Mean 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
95% CI of geometric mean 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
x.xxx-x.xxx 
<Note: Repeat the same table as 14.2.2.6 for albendazole sulfoxide.> 
 
 


 
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14.2.1.7 Plasma concentration of albendazole for Test Product-T1 (first administration) 
 
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Project No. 0110-23 
Table 14.2.1.7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Here Ti (i = 1, 2… .... n) denotes the time points at which blood sample has been taken 
<Note 1: Repeat the same table as 14.2.1.8 for Test Product-T2 (second administration), 14.2.1.9 for Reference Product-R1 (first administration) and 14.2.1.10 for Reference 
Product-R2 (second administration) of albendazole.> 
<Note 2: Repeat the same table as 14.2.2.7 for Test Product-T1 (first administration), 14.2.2.8 for Test Product-T2 (second administration), 14.2.2.9 for Reference Product-R1 (first 
administration) and 14.2.2.10 for Reference Product-R2 (second administration) of albendazole sulfoxide.> 
 
 
 
 
Time 
(unit) 
Plasma concentration of albendazole for 
Test Product-T1 (first administration) 
N 
Mean 
SD 
Min 
Median 
Max 
CV% 
Geometric 
Mean 
Participants 
Concentration (unit) 
1001 
1002 
. 
n 
T1 
xx.xxx 
xx.xxx 
. 
xx.xxx 
xx 
x.xxx 
x.xxxx 
x.xxx 
x.xxx 
x.xxx 
x.x 
x.xxx 
T2 
xx.xxx 
xx.xxx 
. 
xx.xxx 
xx 
x.xxx 
x.xxxx 
x.xxx 
x.xxx 
x.xxx 
x.x 
x.xxx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
Ti 
xx.xxx 
xx.xxx 
. 
xx.xxx 
xx 
x.xxx 
x.xxxx 
x.xxx 
x.xxx 
x.xxx 
x.x 
x.xxx 


 
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14.2.1.11 Plasma concentration of data excluded from statistical analysis for albendazole (if applicable) 
 
Lambda Therapeutic Research Ltd. 
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Project No. 0110-23 
Table 14.2.1.11 
Time (h) 
Plasma concentration of data excluded from statistical analysis for albendazole 
Participants 
Concentration (unit) 
1001 
1002 
. 
n 
Period 
Period 
. 
Period 
Formulation 
Formulation 
Formulation 
T1 
xx.xxx 
xx.xxx 
. 
xx.xxx 
T2 
xx.xxx 
xx.xxx 
. 
xx.xxx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
Ti 
xx.xxx 
xx.xxx 
. 
xx.xxx 
Note: Here Ti (i = 1, 2… .... n) denotes the time points at which blood sample has been taken. 
<Note: Repeat the same table as 14.2.2.12 for albendazole sulfoxide.> 
 
 
 
 
 
 
 
 
 
 
 


 
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14.2.3 Actual time points used for pharmacokinetic evaluation 
 
 
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Table 14.2.3 
Actual time points used for pharmacokinetic evaluation
 
Participants 
Period 
Time Point 
(unit) 
Difference in 
Minutes 
Difference in Hour 
Actual Time of Collection 
(unit) 
1001 
x.xxx 
x.xxx 
x.xxx 
1002 
x.xxx 
x.xxx 
x.xxx 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
. 
n 
x.xxx 
x.xxx 
x.xxx 
 
 
Output Generated on: DDMMMYYYY hh:mm 
 
 
 
 
 
 
 


 
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14.3 Safety Data  
14.3.1 Overall summary of treatment emergent adverse events (Safety set) 
 
Lambda Therapeutic Research Ltd. 
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Project No. 0110-23 
 
Table 14.3.1 
 
Overall summary of treatment emergent adverse events (Safety set) 
 
Test Treatment-T 
(N=xx) 
n (%) e 
Reference Treatment-R 
(N=xx) 
n (%) e 
Total 
(N=xx) 
n (%) e 
p-value 
At least one TEAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
x.xxxx 
At least one TEAE leading to discontinuation 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
x.xxxx 
At least one TESAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
- 
 
 
 
 
 
Assessment of intensity 
 
 
 
- 
  Mild  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Moderate  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Severe  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
Seriousness criteria 
 
 
 
- 
  Congenital Anomaly/Birth Defect 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Hospitalization or prolongation of existing 
hospitalization 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Result in persistent or Significant 
  Disability/incapacity 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Life threatening 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Abnormal pregnancy outcomes 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Death 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Other Medically Important Event 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
Relationship to Study Treatment 
 
 
 
- 
  Related  
 
 
 
 
    Certain  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
    Probable/Likely  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
    Possible  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Not Related  
 
 
 
 
    Unlikely  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
    Conditional/Unclassified  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 


 
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Albendazole Tablets IP 400 mg  
 
Page 44 of 63 
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.1 
 
Overall summary of treatment emergent adverse events (Safety set) 
 
Test Treatment-T 
(N=xx) 
n (%) e 
Reference Treatment-R 
(N=xx) 
n (%) e 
Total 
(N=xx) 
n (%) e 
p-value 
    Unassessable/Unclassifiable  
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
    Unrelated 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
Action Taken with Study Treatment 
 
 
 
- 
  Dose Increased 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Dose Not Changed 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Dose Reduced 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Drug Interrupted 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Drug Withdrawn 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Not Applicable 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Unknown 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
Outcome 
 
 
 
- 
  Not Recovered/Not Resolved 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Recovering/resolving 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Recovered/Resolved 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Recovered/Resolved With Sequelae 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Stable 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Change in severity 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Fatal 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Converted to SAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Unknown 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
  Death 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
N = Number of subjects in respective treatment population. 
n = Number of subjects in respective categories; e = Number of events. 
Percentages are based on the number of subjects allocated to each category.  
P-value is calculated based on a chi-square test. If any cell has expected counts less than 5, then the Fisher’s exact test is 
used instead. 
Reference Listing: 16.2.7.1 
Output Generated on: DDMMMYYYY hh:mm 
  
 


 
Lambda Therapeutic Research Ltd. 
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Albendazole Tablets IP 400 mg  
 
Page 45 of 63 
 
14.3.2 Summary of treatment emergent adverse events by system organ class and preferred term (Safety set) 
 
 
 
 
 
 
 
 
 
 
 
 
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.2 
 
Summary of treatment emergent adverse events by system organ class and preferred term (Safety set) 
 
  System Organ Class 
     Preferred Term 
Test Treatment-T 
(N=xx) 
n (%) e 
Reference Treatment-R 
(N=xx) 
n (%) e 
Total 
(N=xx) 
n (%) e 
 
 
 
 
Subjects with At least one TEAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
System Organ Class 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
. 
. 
. 
 
 
 
 
 
 
 
System Organ Class 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
N = Number of subjects in respective treatment population. 
n = Number of subjects in respective categories; e = Number of events. 
Percentages are based on the number of subjects allocated to each category.  
Each  subjects is counted at the most once within each PT. 
Adverse Events are coded using Medical Dictionary for Regulatory Activities (MedDRA) version xx 
Reference Listing: 16.2.7.1 
Output Generated on: DDMMMYYYY  hh:mm 
 


 
Lambda Therapeutic Research Ltd. 
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Page 46 of 63 
14.3.3 Summary of treatment emergent adverse events by relationship to study drug and system organ class and preferred term (Safety set) 
 
 
 
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.3 
 
Summary of treatment emergent adverse events by relationship to study drug and system organ class and preferred term (Safety set) 
System Organ Class 
    Preferred Term 
Test Treatment-T  
(N=xx) 
n (%) e 
Reference Treatment-R 
(N=xx) 
n (%) e 
Total 
(N=xx) 
n (%) e 
 
Related 
Not-Related 
Related 
Not-Related 
Related 
Not-Related 
 
 
 
 
 
 
 
Subjects with At least one TEAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
 
System Organ Class 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
. 
. 
. 
 
 
 
 
 
 
System Organ Class 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Etc. 
 
 
 
 
 
 
N = Number of subjects in respective treatment population. 
n = Number of subjects in respective categories; e = Number of events. 
Percentages are based on the number of subjects allocated to each category.  
Each subject is counted at most once within each PT. 
Adverse Events are coded using Medical Dictionary for Regulatory Activities (MedDRA) version xx 
Reference Listing: 16.2.7.1 
 
Output Generated on: DDMMMYYYY  hh:mm 
 


 
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Project No. 0110-23 
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Albendazole Tablets IP 400 mg  
 
Page 47 of 63 
14.3.4 Summary of treatment emergent adverse events by severity grade and system organ class and preferred term (Safety set) 
 
 
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.4 
 
Summary of treatment emergent adverse events by severity grade and system organ class and preferred term (Safety set) 
 
  System Organ Class  
     Preferred Term 
Test Treatment-T 
(N=xx) 
n (%) e 
Reference Treatment-R 
(N=xx) 
n (%) e 
Total 
(N=xx) 
n (%) e 
 
 
 
 
Subjects with At least one TEAE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Mild  
 
 
 
System Organ Class 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
. 
. 
. 
 
 
 
 
 
 
 
System Organ Class 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
    Preferred Term 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Etc. 
 
 
 
 
 
 
 
N = Number of subjects in respective treatment population. 
n = Number of subjects in respective categories; e = Number of events. 
Percentages are based on the number of subjects allocated to each category.  
Each subject is counted at most once within each PT. 
Adverse Events are coded using Medical Dictionary for Regulatory Activities (MedDRA) version xx 
Reference Listing: 16.2.7.1 
Output Generated on: DDMMMYYYY  hh:mm 
 


 
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Page 48 of 63 
14.3.5 Summary of subject disposition  
 
Lambda Therapeutic Research Ltd. 
Confidential 
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Table 14.3.5 
 
Summary of subject disposition 
 
TRTR 
(N=xx) 
n (%) 
RTRT 
(N=xx) 
n (%) 
Total 
(N=xx) 
n (%) 
Subjects Randomized 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Subjects included in Safety set 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Subjects included in PK set 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Subjects who completed study  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Subjects who discontinued study  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Reason for discontinuing study 
 
 
 
    Reason 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Reason 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Reason 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Etc. 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Note: Percentages are calculated based on the total number of subjects in each category. 
Treatment specification -> T = Test Product and R = Reference Product. 
Reference Listing: 16.2.1.2 
Output Generated on: DDMMMYYYY  hh:mm 
 
<Note for programmers: Reason for discontinued should be in descending order i.e., highest reported reasons should come first.> 
 
 
 


 
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Page 49 of 63 
14.3.6 Summary of vital signs (Safety set) 
 
Lambda Therapeutic Research Ltd. 
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Table 14.3.6 
 
Summary of vital signs (Safety set) 
Parameters 
(Unit) 
Visit (Day) 
Time Point 
Statistics 
TRTR 
 (N=xx) 
RTRT 
 (N=xx) 
Total 
(N=xx) 
p-value 
Pulse rate 
(beats/min) 
Screening 
 
n 
xx 
xx 
xx 
x.xxxx 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
 
Assessment 
Visit X 
Time Point 1 
n 
xx 
xx 
xx 
x.xxxx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
 
 
 
Time Point 2 
n 
xx 
xx 
xx 
x.xxxx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
 
 
Assessment 
Visit Y 
Time Point 1 
n 
xx 
xx 
xx 
x.xxxx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Etc. 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
P-value is calculated using an independent t-test. 
Treatment specification -> T = Test Product and R = Reference Product. 
Reference Listing: 16.2.9.4 
 
Output Generated on: DDMMMYYYY  hh:mm 
 
<Note for programmers: This table will continue for vital parameters like Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Oral Body Temperature (oF), etc.> 
 
 


 
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Page 50 of 63 
14.3.7 Summary of change from baseline for vital signs (Safety set) 
 
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Table 14.3.7 
 
Summary of change from baseline for vital signs (Safety set) 
Parameters 
(Unit) 
Visit (Day) 
Time Point 
Statistics 
TRTR 
 (N=xx) 
RTRT 
 (N=xx) 
Total 
(N=xx) 
Diastolic Blood 
Pressure (mmHg) 
Assessment 
Visit X 
Time Point 1 
n 
xx 
xx 
xx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
 
Time Point 2 
n 
xx 
xx 
xx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Assessment 
Visit Y 
Time Point 1 
n 
xx 
xx 
xx 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
Etc. 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Change from Baseline (CFB) = Post Baseline assessment – Baseline assessment (0.00 Hrs Pre-Dose). 
Treatment specification -> T = Test Product and R = Reference Product. 
Reference Listing: 16.2.9.4 
 
Output Generated on: DDMMMYYYY  hh:mm 
 
 


 
Lambda Therapeutic Research Ltd. 
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Albendazole Tablets IP 400 mg  
 
Page 51 of 63 
 
14.3.8 Summary of quantitative safety laboratory variables (Safety set) 
  
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.8 
 
Summary of quantitative safety laboratory variables (Safety set) 
Parameters 
(Unit) 
Visit 
Statistics 
TRTR 
 (N=xx) 
RTRT 
 (N=xx) 
Total 
(N=xx) 
Hemoglobin  
(g/dL) 
Screening 
n 
xx 
xx 
xx 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
Assessment Visit X 
n 
xx 
xx 
xx 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
Assessment Visit Y 
n 
xx 
xx 
xx 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
Median 
xx.x 
xx.x 
xx.x 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Treatment specification -> T = Test Product and R = Reference Product. 
Quantitative data values observed out of limit of quantification are adjusted to quantification limits for descriptive statistics. 
In case of repeat sample collection latest result has been considered for the analysis. 
Reference Listings: 16.2.8.1 
Output Generated on: DDMMMYYYY  hh:mm 
 
<Note to Programmer: This table will continue for all other Laboratory parameters and some additional test.> 


 
Lambda Therapeutic Research Ltd. 
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Albendazole Tablets IP 400 mg  
 
Page 52 of 63 
14.3.9 Summary of qualitative safety laboratory variables (Safety set) 
  
Lambda Therapeutic Research Ltd. 
Confidential 
Project No. 0110-23 
 
Table 14.3.9 
 
Summary of qualitative safety laboratory variables (Safety set) 
Parameters (Unit) 
Visit 
Result 
Statistics 
TRTR 
 (N=xx) 
RTRT 
 (N=xx) 
Total 
(N=xx) 
HBsAg 
Screening 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessment Visit X 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessment Visit Y 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
xxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Note: Percentages are calculated based on the total number of subjects in each category. 
Treatment specification -> T = Test Product and R = Reference Product. 
In case of repeat sample collection latest result has been considered for the analysis. 
Reference Listing: 16.2.8.1 
Output Generated on: DDMMMYYYY  hh:mm 
 
<Note to Programmer: This table will continue for all other Laboratory parameters and some additional test.> 
 
 
 


 
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Page 53 of 63 
14.3.10 Summary of concomitant medication (Safety set) 
 
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Table 14.3.10 
 
Summary of concomitant medication (Safety set) 
 
TRTR 
(N=xx) 
n (%) 
RTRT 
(N=xx) 
n (%) 
Total 
(N=xx) 
n (%) 
At least one concomitant medication 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
    Medication 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Medication 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Medication 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Etc. 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
N = Number of subjects in safety set, n = Number of subjects in respective categories 
Note: Percentages are calculated based on the total number of subjects in each category. 
Treatment specification -> T = Test Product and R = Reference Product. 
Reference Listing: 16.2.10 
Output Generated on: DDMMMYYYY  hh:mm 
 
 
 


 
Lambda Therapeutic Research Ltd. 
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Albendazole Tablets IP 400 mg  
 
Page 54 of 63 
 
In-text tables 
 
Table 1: Summary of Adverse events 
 
Adverse events (as per MedDRA  
PT - Version xxx) 
Albendazole tablets IP  
400 mg 
Test (T) 
Albendazole 400 mg 
tablets 
Reference (R) 
Total 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
x 
x 
x 
Total 
x 
x 
x 
 
 
 
 
 
 
 
 
 


 
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Albendazole Tablets IP 400 mg  
 
Page 55 of 63 
Table 2: Summary of Adverse Events with System Organ Class 
 
System Organ Class 
MedDRA (PT)  
(Version xxx) 
Albendazole tablets IP  
400 mg 
Test (T) 
Albendazole 400 mg 
tablets 
Reference (R) 
No. of events 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
XXXXXXXXX 
XXXXXXXXX 
x 
x 
x 
Total 
 
x 
x 
x 
 
 
 


 
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Page 56 of 63 
Listings 
 
16.2.1 Subject disposition 
  
16.2.1.1 Screen failure subjects  
 
 
 
 
 
 
 
Screening 
No. 
Date of 
screening 
If Non-fulfillment of 
inclusion/exclusion criteria or 
Protocol Violation, please specify 
 If 'Death', Date of  
Death 
 
 
 
 
 
16.2.1.2 Study completion status 
 
Subject 
no. 
Sequence 
Subject Study 
Completion Status 
Date of Completion or 
Premature Discontinuation 
Date of last dose of study 
drug administration 
Reason for 
Discontinuation 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
If 'Other', 'Physician decision', 'Withdrawal 
by subject', ‘Adverse event’, specify 
If Non-fulfilment of inclusion/exclusion 
criteria or Protocol Violation, specify 
If 'Death', 
Date of Death 
 
 
 
 
 
 
16.2.1.3 Subject distribution in analysis population 
 
Subject no. 
Sequence 
Subjects included in 
Randomized set 
Subjects included in 
Safety set 
Subjects included 
in PK set 
 
 
 
 
 
 
16.2.1.4 Inclusion - Exclusion criteria 
 
Subject 
no. 
Sequence 
Does the subject meet 
all inclusion criteria? 
If No, Mark the INCLUSION 
criterion number(s) not met 
Does the subject meet 
any exclusion criteria? 
If Yes, Mark the EXCLUSION 
criterion number(s) met 
 
 
 
 
 
 
 
 
 
Screening 
No. 
Date of 
screening 
 Subject Study 
Completion Status 
Reason for Screen 
Failure 
If 'Other', 'Physician decision', 
'Withdrawal by subject', 
 please specify 
 
 
 
 
 


 
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16.2.1.5 Inclusion criteria description 
 
Code 
Inclusion criteria description 
 
 
 
16.2.1.6 Exclusion criteria description 
 
Code 
Exclusion criteria description 
 
 
 
16.2.2 Protocol deviations  
 
Subject 
no. 
Sequence Visit 
No.  
Date of deviation 
Occurrence  
Protocol 
Section 
Protocol 
requirement 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
Visit 
No. 
Type 
(Major/Minor) 
Reason for 
deviation 
Description 
of the 
Deviation 
Corrective 
Action 
Preventive 
Action 
Impact 
Assessment 
 
 
 
 
 
 
 
 
 
<Note: Listing will be displayed as per available data from the source.> 
16.2.3 Subjects excluded from the analysis 
 
16.2.3.1 Subjects excluded from the analysis (PK set) 
 
Subject No. 
Period 
Reason 
 
 
 
 
 
 


 
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16.2.4 Demographic data 
16.2.4.1 Demographic data and baseline characteristics 
 
Screening 
no. 
Subject 
no. 
Sequence 
Date of Informed 
consent form 
signed 
(Screening) 
Date of Informed 
consent form 
signed 
(Study Specific) 
Date of 
Birth 
Age 
(Years) 
Gender 
Ethnicity  
Race 
If Other, 
please 
specify 
 
 
 
 
 
 
 
 
 
 
 
< Note for programmers: This listing will be created on Randomized set.> 
 
16.2.4.2 Personal history  
 
Subject 
no. 
Sequence 
Personal history assessment 
done for female subject? 
Reproductive 
status 
 
 
 
 
 
16.2.4.3 Medical and surgical history details 
 
Subject 
no. 
Sequence 
Visit 
Nature of 
condition 
Medical/Surgical 
history term 
Medical/Surgical 
history code 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
Visit 
Start 
date 
End 
date 
Ongoing 
 
 
 
 
 
 
 
16.2.4.4 Physical examination 
 
Subject 
no. 
Sequence 
Visit 
Date of 
assessment 
Body 
System 
Result 
Specify if 
Abnormal 
CS/Not Done 
Any New clinically significant 
abnormality finding or worsening of 
condition since last assessment? 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
Visit 
If yes, please 
select body System 
If yes, please 
specify abnormality 
 
 
 
 
 
 
 
 


 
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16.2.4.5 Medication history  
 
Subject 
no. 
Sequence 
Subject taken any medication from 14 days 
prior to dosing of period I? 
 
 
 
 
16.2.5 Compliance and drug concentration data  
 
16.2.5.1 Study drug administration  
 
Subject 
no. 
Sequence 
Visit 
Study drug 
administration 
performed? 
Date of study drug 
administration 
Time of Study 
drug 
administration 
Mouth check 
done after 
dosing? 
If 'No', 
then 
specify 
Any deviation 
during dosing? 
If 'Yes', 
please 
specify 
 
 
 
 
 
 
 
 
 
 
 
16.2.5.2 Compliance assessment 
 
Subject 
no. 
Sequence 
Visit 
Has the subject been compliant to 
all pre dose compliance criteria?: 
If 'No', then 
specify 
Has the subject been compliant to 
all post dose compliance criteria? 
If No, then 
specify 
 
 
 
 
 
 
 
 
16.2.5.3 PK sample collection  
 
Subject 
no. 
Sequence 
Visit 
Time 
point 
Actual Date of PK 
sample collection 
Actual Time of PK 
sample collection 
Any 
Deviation? 
If ‘Yes’, please 
specify 
 
 
 
 
 
 
 
 
 
16.2.5.4 Concentration-time data for albendazole 
 
Participant Sequence 
Period 
Formulation 
Form 
Schedule Time 
(h) 
Actual Time 
(h) 
Concentration  
(unit) 
 
 
 
 
 
 
 
 
Programming note: Similar listing will be generated for albendazole sulfoxide as 16.2.5.6. 
 
16.2.5.5 Pharmacokinetic data for albendazole 
 
Participant Sequence 
Period Formulation 
Form 
Tmax 
(h) 
Cmax 
(unit) 
AUC0-t 
(unit) 
AUC0-inf 
(unit) 
AUC_%Extrap_obs 
(%) 
Lambda_z 
(unit) 
t1/2 
(unit) 
 
 
 
 
 
 
 
 
Programming note: Similar listing will be generated for albendazole sulfoxide as 16.2.5.7. 
 


 
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16.2.7 Adverse events (each subject)  
 
16.2.7.1 Adverse events by severity, relationship to the study drug and by MedDRA term 
 
Subject 
no. 
Treatment 
Adverse 
event term 
Adverse 
Event Code 
Start 
date 
Start 
Time 
End 
date 
End 
time 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Treatment Assessment of 
intensity 
Is this 
adverse event 
serious? 
If Serious, Please 
specify seriousness 
criteria 
Relationship 
to Study 
Treatment 
Action 
Taken with 
Study 
Treatment 
Outcome 
Concomitant 
treatment/Therapy 
given 
 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Treatment Preferred 
Term 
Preferred 
Term code 
System 
Organ 
Class 
Lowest 
Level 
Term 
Lowest 
Level 
Term Code 
High 
Level 
Term 
High Level 
Term Code 
High Level 
Group Term  
High Level 
Group Term 
Code 
 
 
 
 
 
 
 
 
 
 
 
Note: Only subjects having an adverse event are included in this listing. 
 
16.2.7.2 Serious adverse events (if applicable)  
 
Subject 
no. 
Treatment 
Adverse 
event term 
Adverse 
Event Code 
Start 
date 
Start 
Time 
End 
date 
End 
time 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Treatment Preferred 
Term 
Preferred 
Term code 
System 
Organ 
Class 
Lowest 
Level 
Term 
Lowest 
Level 
Term Code 
High 
Level 
Term 
High Level 
Term Code 
High Level 
Group Term  
High Level 
Group Term 
Code 
 
 
 
 
 
 
 
 
 
 
 
Note: Only subjects having serious adverse events are included in this listing. 
 
 
 
 
 
 
 
 
 


 
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16.2.8 Listing of individual laboratory measurements (by Subject) 
 
16.2.8.1 Central laboratory tests 
 
Laboratory Test group 
Subject 
no. 
Sequence Visit 
Date of 
sample 
collection 
Time of 
sample 
collection 
Laboratory 
Test 
Unit 
Laboratory 
range - 
Minimum 
Laboratory 
range - 
Maximum 
Laboratory 
Results 
Flagging 
(L/H/A/N) 
 
 
 
 
 
 
 
 
 
 
 
 
16.2.8.2 Safety Laboratory analysis 
 
Subject 
no. 
Sequence 
Visit 
Date of sample 
collection 
Time of sample 
collection 
Specimen 
Type 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
Visit 
Panel 
Name 
Overall 
Interpretation 
If Abnormal 
CS, specify 
Repeat sample 
status 
If 'Other', 
then specify 
 
 
 
 
 
 
 
 
 
16.2.9 Individual subject data listings 
 
16.2.9.1  12 Lead electrocardiogram  
 
Subject 
no. 
Sequence 
Date of 
Assessment Interpretation 
If Interpretation is “Abnormal 
CS”, please specify 
 
 
 
 
 
 
16.2.9.2 Chest x-ray  
 
Subject 
no. 
Sequence 
Visit 
Date of 
assessment 
Interpretation 
If Abnormal CS, 
please specify 
 
 
 
 
 
 
 
16.2.9.3 Body measurements 
 
Subject no. 
Sequence 
Height(cm) 
Weight (Kgs) 
BMI(kg/m2) 
 
 
 
 
 
< Note for programmers: This listing will be created on Randomized set.> 
 


 
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16.2.9.4 Vital signs  
 
Subject 
no. 
Sequence Visit 
Time 
Point 
Date of 
measurement 
Time of 
measurement 
Systolic blood 
pressure 
Diastolic blood 
pressure 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Sequence Visit 
Radial 
pulse 
Respiratory 
rate 
Body 
temperature 
Interpretation 
If Abnormal CS, 
please specify 
CFB 
 
 
 
 
 
 
 
 
 
Change from Baseline (CFB) = Post Baseline assessment – Baseline assessment (0.00 Hrs Pre-Dose) 
 
16.2.9.5 Urine drug scan and breath alcohol test 
 
Subject 
no. 
Sequence Visit 
Date of 
assessment 
Urine drug 
scan result 
Breath 
alcohol test 
result 
 
 
 
 
 
 
 
16.2.9.6 Lifestyle compliance assessment 
 
Subject no. 
Sequence 
Visit 
Subject followed all the instruction of 
lifestyle restriction as per protocol? 
If "No" then specify 
 
 
 
 
 
 
16.2.9.7 Subjects date of visit 
 
Subject no. 
Sequence 
Visit 
Date of Visit 
 
 
 
 
< Note for programmers: This listing will be created on Randomized set.> 
 
16.2.9.8 Unscheduled visit (if applicable) 
 
Subject 
no. 
Sequence 
Reason for 
unscheduled 
visit 
Date of 
unscheduled 
visit 
Activity 
Name 
If Other, 
please 
specify 
If any abnormal clinically 
significant findings, then 
provide details 
 
 
 
 
 
 
 
 
 
 
 
 


 
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16.2.10 Prior - Concomitant medication 
 
Subject 
no. 
Sequence 
Medication 
Name or 
Therapy 
Medication 
Code 
Indication 
code 
Indication 
Dose per 
administration 
Unit 
If 'Other' 
(Unit), please 
specify 
 
 
 
 
 
 
 
 
 
 
Subject 
no. 
Sequence 
Frequency 
If 'Other' 
(Frequency), 
please specify 
Route 
If 'Other' 
(Route), please 
specify 
Start 
date 
End date 
Ongoing