Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine
Phase: PHASE1
Conditions: Hypertension
Sponsor: Conjupro Biotherapeutics, Inc.

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Clinical Study Protocol 
 
 
A Randomized, Open-label, Single-Dose, Two-Way Crossover Study 
to Assess the Relative Bioavailability of 5 mg of Levamlodipine 
Maleate Tablets versus 10 mg of Amlodipine Besylate Tablet 
(NORVASC® from Pfizer Inc.) in Healthy Subjects Followed by a 
Phase to Study Food Effect on the PK Profile of Levamlodipine 
 
Short Title:  
BA Study of Levamlodipine vs NORVASC® 
IND Number:  
124,947 
Drug Name:  
Levamlodipine，the (S)amlodipine 
Study Phase:  
Phase 1 
Protocol Number: 
LAM-US-101 
Protocol Version: 
Version 1.0 issued on February 23rd 2018  
Version 2.0 issued on May 21st 2018 
Sponsor: 
CSPC Ouyi Pharmaceutical Co., Ltd, a subsidiary company within CSPC 
Pharmaceutical Group, Ltd (CSPC) 
 
The study will be conducted in compliance with the protocol, ICH-GCP and any applicable 
regulatory requirements. 
Confidentiality Statement 
The confidential information in this document is provided to you as a Principal 
Investigator or consultant for review by you, your staff and the applicable Institutional 
Review Board / Independent Ethics Committee. Your acceptance of this document 
constitutes agreement that you will not disclose the information contained herein to others 
without written authorization from the Sponsor. 

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Main Changes Made to Version 1.0 to Generate Version 2.0 
 
• eCRF has been changed to CRF, since paper CRFs will be used in this study. 
• Wordings regarding urine samples for PK analysis have been deleted, since PK analysis 
will be done with plasma samples only.  
• Wordings regarding blinding have been deleted, since this will be an open-label study. 
• Wordings regarding barista cards have been deleted, since study drugs are packed in 
bottles. 
• ECG for Day 2 in Table 5-3 has been deleted. 
• Examples of acceptable contraceptive methods for females of childbearing potentials 
have been added. 
• Few editorial changes have been made to further improve the quality of this protocol.  
 

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Table of Contents 
 
1. 
PROTOCOL SYNOPSIS ............................................................................................... 8 
2. 
LIST OF ABBREVIATIONS ....................................................................................... 14 
3. 
INTRODUCTION ........................................................................................................ 16 
4. 
STUDY OBJECTIVES ................................................................................................. 16 
5. 
INVESTIGATIONAL PLAN ....................................................................................... 16 
5.1. 
Study Design ................................................................................................................. 16 
5.2. 
Study Methods .............................................................................................................. 17 
5.3. 
Number of Subjects....................................................................................................... 21 
5.4. 
Treatment Assignment .................................................................................................. 21 
5.5. 
Criteria for Study Termination...................................................................................... 21 
6. 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................ 21 
6.1. 
Subject Inclusion Criteria ............................................................................................. 21 
6.2. 
Subject Exclusion Criteria ............................................................................................ 22 
6.3. 
Prior and Concomitant Medication and Substance ....................................................... 23 
6.4. 
Subject Withdraw Criteria ............................................................................................ 23 
7. 
STUDY PROCEDURES .............................................................................................. 24 
7.1. 
Part 1- Period One ......................................................................................................... 24 
7.1.1. 
Screening (Day -21 to -1) ............................................................................................. 24 
7.1.2. 
Baseline (Day 0) ........................................................................................................... 25 
7.1.3. 
Dosing (Day 1) .............................................................................................................. 26 
7.1.4. 
Days 2 through 7 ........................................................................................................... 26 
7.1.5. 
Day 8 ............................................................................................................................. 26 
7.2. 
Part 1- Period Two ........................................................................................................ 27 
7.2.1. 
Admission (Day 0) ........................................................................................................ 27 
7.2.2. 
Dosing (Day 1) .............................................................................................................. 27 
7.2.3. 
Days 2 through 7 ........................................................................................................... 28 
7.2.4. 
Day 8 ............................................................................................................................. 28 

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7.3. 
Part 2 (Food Effect) ...................................................................................................... 28 
7.3.1. 
Admission (Day 0) ........................................................................................................ 28 
7.3.2. 
Dosing (Day 1) .............................................................................................................. 29 
7.3.3. 
Days 2 through 7 ........................................................................................................... 30 
7.3.4. 
Day 8 ............................................................................................................................. 30 
7.4. 
Early Withdrawal Visit ................................................................................................. 30 
8. 
TREATMENT OF SUBJECTS .................................................................................... 30 
8.1. 
Methods of Assigning Subjects in Part 1 ...................................................................... 30 
8.2  
Methods of Assigning Subjects in Part 2 ...................................................................... 30 
9. 
STUDY DRUG MATERIALS AND MANAGEMENT ............................................. 31 
9.1. 
Study Drug Packaging and Labeling ............................................................................ 31 
9.2. 
Study Drug Storage and Accountability ....................................................................... 31 
9.3. 
Study Drug Handling and Disposal .............................................................................. 31 
10. 
PHARMACOKINETICS ASSESSMENTS ................................................................. 31 
10.1. 
Blood Sample Collection .............................................................................................. 32 
10.2. 
Sample Storage and Shipping ....................................................................................... 32 
10.3. 
Specimen Labeling........................................................................................................ 32 
10.4. 
Sample Shipping Instructions ....................................................................................... 32 
10.5. 
Bioanalytical Methodology ........................................................................................... 32 
10.6. 
PK Parameters ............................................................................................................... 32 
11. 
ASSESSMENT OF SAFETY ....................................................................................... 33 
11.1.1. 
Medical History ............................................................................................................ 33 
11.1.2. 
Vital Signs ..................................................................................................................... 33 
11.1.3. 
Physical Examination.................................................................................................... 33 
11.1.4. 
Electrocardiogram ......................................................................................................... 33 
11.1.5. 
Clinical Laboratory Assessments .................................................................................. 34 
11.2. 
Adverse Events ............................................................................................................. 34 
11.2.1. 
Definitions of Adverse Events ...................................................................................... 35 
11.2.2. 
Adverse Events of Special Interest ............................................................................... 36 
11.2.3. 
Recording Adverse Events ............................................................................................ 37 

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11.2.4. 
Reporting of Serious Adverse Events ........................................................................... 37 
11.2.5. 
Adverse Event Follow-up ............................................................................................. 38 
12. 
STATISTICAL METHODOLOGY ............................................................................. 38 
12.1. 
Sample Size Determination........................................................................................... 38 
12.2. 
Analysis Population ...................................................................................................... 38 
12.3. 
Pharmacokinetics .......................................................................................................... 38 
12.4. 
Demographic Characteristics ........................................................................................ 39 
12.5. 
Exposure to Study Drug ................................................................................................ 39 
12.6. 
Concomitant Medications ............................................................................................. 39 
12.7. 
Safety Analyses ............................................................................................................. 39 
13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ........................................... 40 
13.1. 
Study Monitoring .......................................................................................................... 40 
13.2. 
Sponsor’s Responsibility .............................................................................................. 40 
13.3. 
Audits and Inspections .................................................................................................. 40 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE ............................................ 41 
15. 
ETHICS......................................................................................................................... 41 
15.1. 
Ethics Review ............................................................................................................... 42 
15.2. 
Ethical Conduct of the Study ........................................................................................ 42 
15.3. 
Written Informed Consent ............................................................................................ 43 
16. 
DATA HANDLING AND RECORD KEEPING ........................................................ 43 
16.1. 
Data Collection ............................................................................................................. 43 
16.2. 
Case Report Form Completion ..................................................................................... 43 
16.3. 
Database Management, Data Clarification, and Quality Assurance ............................. 44 
16.4. 
Inspection of Records/Source Documents .................................................................... 44 
16.5. 
Retention of Records..................................................................................................... 45 
17. 
CONFIDENTIALITY................................................................................................... 45 
17.1. 
Subject Data Protection................................................................................................. 46 
18. 
STUDY PROTOCOL AMENDMENTS ...................................................................... 47 
19. 
PUBLICATION ............................................................................................................ 47 
APPENDIX A. 
LABORATORY ASSESSMENTS ................................................................. 48 

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1. 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company 
CSPC Ouyi Pharmaceutical Co., Ltd, a subsidiary company within CSPC 
Pharmaceutical Group, Ltd (CSPC) 
Title of Study 
A Randomized, Open-label, Single-Dose, Two-Way Crossover Study to Assess the 
Relative Bioavailability of 5 mg of Levamlodipine Maleate Tablets versus 10 mg of 
Amlodipine Besylate Tablet (NORVASC® from Pfizer Inc.) in Healthy Subjects 
Followed by a Phase to Study Food Effect on the PK Profile of Levamlodipine 
Phase of Development 
Phase 1 
Investigational Product, Dosage and Mode of Administration 
Levamlodipine Maleate Tablet is a new investigational drug for the treatment of 
hypertension and Coronary Artery Disease (CAD) chronic stable angina. 
Levamlodipine is the pharmacologically active isomer in amlodipine, which presents 
in amlodipine as a 1:1 mixture with the (R)amlodipine. The to-be-marketed dosage 
strengths planned in the US are 1.25, 2.5 and 5 mg of levamlodipine maleate tablets 
with an anticipated dosage regimen of once daily. 
Name of Active Ingredient 
Levamlodipine，the (S)amlodipine 
Reference Therapy, Dosage and Mode of Administration 
Amlodipine Besylate Tablet (NORVASC® from Pfizer Inc.) 
Study Center 
Collaborative Neuroscience Network, LLC (CNS) 
2600 Redondo Avenue, Suite 500 
Long Beach, CA 90806 
Principal Investigator 
Mark Todd Leibowitz, MD 
Objectives 

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The objectives of this study are (1) to assess the relative bioavailability (BA) of a 
single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 
mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting 
condition in male and female healthy subjects; and (2) to evaluate food effect on the 
PK profile of Levamlodipine Maleate Tablets from CSPC. 
Study Design 
This study consists of 2 parts:  
Part 1 will be a randomized, open-label, single-dose, two-way crossover study to 
assess the relative BA of levamlodipine maleate tablets from CSPC (Test) versus 
Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. (Reference) after a single 
oral administration under fasted conditions in male and female healthy subjects. 
Approximately 32 healthy subjects will be enrolled in the US to obtain 27 completed 
subjects.  
Eligible subject will be randomized to receive one of two treatment sequences (RT 
or TR; R=10 mg of NORVASC® and T=5 mg of levamlodipine maleate tablets) 
according to a randomization schedule prepared prior to the start of the study. All 
study drugs will be administered following an overnight fast for approximately 10 
hours. 
Eligible subjects will be admitted to the clinical research center (CRU) within 
24 hours before baseline assessments in Period One and will stay at the CRU for 3 
nights. A single dose of study drug should be taken orally with 240 ml (about 8 fluid 
ounces) of water at site after being fasted overnight, and meal will be allowed around 
1 hour after dosing. Subjects should return to the CRU on Days 4 till 8 to provide PK 
samples and to receive study assessments. Serial blood samples will be obtained at 
defined time points for 7 days after dosing in each treatment for the measurement of 
plasma (S)amlodipine and (R)amlodipine concentrations.  
After a wash-out period for at least 14-days since the last dosing, subjects will enter 
into Period Two to receive alternative reference or test drug. Thus, subjects who 
receive levamlodipine treatment in Period One will now receive NORVASC® 
treatment in Period Two, while subjects who receive NORVASC® treatment in 
Period One will now receive levamlodipine treatment in Period Two. The same 
procedure will be performed at approximately same time points as noted for Period 
One. 
Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on 
the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have 
completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-
days since the last dosing. Subjects will receive a single oral administration of study 
drug under a high-fat / high-calorie meal that should derive approximately 150, 250 
and 500-600 calories from protein, carbohydrate and fat, respectively. 
Following an overnight fast for approximately 10 hours, subjects should start the 

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recommended meal 30 minutes prior to administration of study drug. Study subjects 
are to eat this meal in 30 minutes or less. The study drug should be administered 
with 240 mL (about 8 fluid ounces) of water immediately after the meal. No food 
should be allowed for at least 4 hours post-dose. Water can be allowed as desired 
except the one-hour period before and after drug administration. Subjects should 
receive standardized meals scheduled at approximately same time in each period of 
the study. 
Subjects will be admitted to the CRU within 24 hours before drug administration and 
will stay at the CRU for 3 nights. Subjects should return to the CRU on Days 4 till 8 
to provide PK samples and to receive study assessments. Serial blood samples will 
be obtained at defined time points for the measurement of plasma (S)amlodipine and 
(R)amlodipine concentrations.  
Safety and tolerability will be monitored during the study. 
Methodology 
PK 
A total of 23 blood samples will be collected at the following time points: within 30 
min prior to dosing and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 72, 
96, 120, 144, and 168 hours after each dosing.  
Each plasma sample prepared from blood PK sample will be divided into two equal 
parts, one as primary PK sample and one as back-up PK sample. Plasma 
concentrations of (S)amlodipine and (R)amlodipine will be measured with validated 
methods under GLP. 
The plasma concentration time data for (S)amlodipine and (R)amlodipine will be 
analyzed using non-compartmental methods. Actual dosing and sampling times will 
be used for analyses. The primary PK parameters of interest are: Cmax, tmax, tlag, t1/2, 
λz, MRTinf, AUClast, AUCinf, AUCextrap, Cl/F and Vd/f. Additional parameters may be 
estimated and reported, as appropriate. 
Safety 
Safety assessments will include the summaries of adverse events (AEs), vital signs, 
laboratory findings, 12-lead electrocardiography (ECG), and physical examination 
findings at various time points during the study.  
Planned Subject Number 
The planned total subject number for Part 1 is about 32 healthy volunteers in order to 
obtain 27 completed subjects. Subjects who have completed Part 1 will be rolled 
over to Part 2 to assess food effect on the PK profile of levamlodipine maleate 
tablets from CSPC. 
Subject Selection Criteria 

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Inclusion Criteria 
To participate in the study, subjects must meet all the following eligibility criteria at 
screening or admission: 
1. Are capable of giving informed consent and complying with study procedures; 
2. Are between the ages of 18 and 45 years old, inclusive; 
3. Women of childbearing potential (WOCBP) must have a negative pregnancy test 
at Screening and be practicing a medically acceptable method of contraception 
with an annual failure rate of less than 1% during the study and 60 days after 
discontinuation of study treatment. Women are considered not childbearing 
potential if they are > 1 year postmenopausal or surgically sterile 
(ie, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal 
ligation). If serum βHCG is the standard of care, then this value can be used to 
determine eligibility 
4. Considered healthy by the Principal Investigator, based on a detailed medical 
history, full physical examination, clinical laboratory tests, 12-lead ECG and 
vital signs;  
5. Nonsmoker, defined as not having smoked or used any form of tobacco in more 
than 6 months before screening;  
6. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less 
than 50 kg; 
7. Willing and able to adhere to study restrictions and to be confined at the clinical 
research center. 
Exclusion Criteria 
Subjects will be excluded from study entry if any of the following exclusion criteria 
are present at screening or admission: 
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, 
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, 
neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; 
2. Subjects with a mean systolic blood pressure of three measurements >140 
mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at 
screening. Blood pressure will be measured at sitting position; 
3. Known or suspected malignancy; 
4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B 
surface antigen (HBsAg), or hepatitis C virus (HCV);  
5. A history of seizure. However, a history of febrile seizure is allowed; 
6. Positive pregnancy test result, or plan to become pregnant if female; 
7. A hospital admission or major surgery within 30 days prior to screening; 

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8. Participation in any other investigational drug trial within 30 days prior to 
screening; 
9. DSM-V substance use disorders within 6 months prior to screening; 
10. A positive result for alcohol or drugs of abuse at screening or admission; 
11. Tobacco use within 6 months prior to screening; 
12. An unwillingness or inability to comply with food and beverage restrictions 
during study participation; 
13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood 
(or blood products) or acute loss of blood during the 90 days prior to screening; 
14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines 
(including St John’s Wort, herbal teas, garlic extracts) within 14 days prior to 
dosing; 
15. A history of suicide attempt in the past 12 months and/or seen by the investigator 
as having a significant history of risk of suicide or homicide; 
16. A history of intolerance or hypersensitivity to amlodipine or any excipients; 
17. An unwillingness of male participants to use appropriate contraceptive measures 
if engaging in sex intercourse with a female partner of childbearing potential 
during the study and 60 days after discontinuation of study treatment. Sexual 
intercourse with pregnant or lactating women is prohibited. 
Duration of Study 
The total duration of the study for each completed subject is about 2 months, 
including about 44 days for Part 1 (up to 21 days for screening, 14 days for Period 
One before cross-over and 9 days for Period Two after cross-over) and about 14 days 
for Part 2 (5 days before dosing and 9 days after dosing).  
 
Statistical Methods 
PK 
All the PK parameters and baseline subject characteristics will be summarized using 
descriptive statistics. The following PK parameters for plasma (S)amlodipine and 
(R)amlodipine concentrations will be compared between the study treatments by 
analysis of variance (ANOVA) including subject, treatment, and sequence effects in 
the model. Statistical significance will be tested at the 0.05 level (2-sided): 
• AUC0-t (Area under the concentration-time curve up to the time of the last 
quantifiable concentration) 
• AUC0-∝ (Area under the concentration-time curve extrapolated to infinity) 
• Cmax 
• tmax 

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• t1/2 
AUC0-t, AUC0-∝ and Cmax will present estimates of extent and rate of absorption. tmax 
will be compared between treatments using the Wilcoxon-Singed Ranks test.  
Relative bioavailability of Levamlodipine Maleate Tablets (T) and NORVASC® (R) 
will be determined based on AUC0-t, AUC0-inf and Cmax of (S)amlodipine. The 90% 
confidence intervals (CIs) on the ratio of test to reference drugs will be calculated. 
Log-transformed PK parameters AUC0-t, AUC0-inf and Cmax will be analyzed using 
ANOVA including terms for sequence, treatment, and period as fixed effects, and 
subject nested within sequence as a random effect. Bioequivalence limits will be 80–
125%. 
The PK parameters for plasma (S)amlodipine and (R)amlodipine concentrations will 
be compared within treatment of either Levamlodipine Maleate Tablets or 
NORVASC® to determine possible conversion of the 2 isomers in vivo. 
Food effect will be evaluated based on AUC0-t, AUC0-inf and Cmax of (S)amlodipine 
and will be determined by the changes of log-transformed PK parameters under 
fasting conditions and fed conditions. 
Safety 
Safety data will be summarized using descriptive statistics for all subjects who 
receive study drugs.  
AEs will be coded using the MedDRA Dictionary, listed by subject and summarized 
frequency (number) for each treatment. Prior and concomitant medications will be 
coded using the World Health Organization (WHO) Drug Dictionary, and listed by 
reported term and Anatomical Therapeutic Class classification. 
Any abnormal findings in physical examination and clinical laboratory tests will be 
summarized by treatment. Change from baseline will be calculated for clinical 
laboratory tests. For ECGs, the frequency (number) of clinically significant findings 
will be reported and summarized by treatment. 

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2. 
LIST OF ABBREVIATIONS 
The following abbreviations and specialist terms are used in this study protocol. 
Abbreviation 
Term 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
ANOVA 
Analysis of variance 
AST 
Aspartate aminotransferase 
AUC 
Area under curve 
AUCinf 
Area under the analyte concentration-time curve from time 0 and 
extrapolated to infinite time, total exposure 
AUClast 
Area under the analyte concentration time curve from time 0 to last 
quantifiable concentration 
BMI 
body mass index 
BP 
Blood pressure 
BUN 
Blood urea nitrogen 
Cmax 
Maximum concentration 
Con med 
Concomitant medication 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CRF 
Case report form 
CRO 
Contract research organization 
CRU 
Clinical research unit 
CSPC Pharma 
CSPC Pharmaceutical Co., Ltd. 
ECG 
Electrocardiography 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyl-transferase 
Hct 
Hematocrit 
HCV 
Hepatitis C virus 
Hgb 
Hemoglobin 
HIV 
Human immunodeficiency virus 

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Abbreviation 
Term 
IB 
Investigational brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
LC-MS/MS 
Tandem mass spectrometric detection 
LDH 
Lactate dehydrogenase 
MedDRA 
Medical Dictionary for Regulatory Activities 
NOAEL 
No observable adverse effect level 
OTC  
Over the Counter 
PHI 
Protected health information 
PK 
Pharmacokinetic(s) 
R 
Reference product 
RBC 
Red blood cell 
SAE 
Serious adverse event 
SAD 
Single ascending dose 
SDV 
Source document verification 
t½ 
Half life 
T 
Test product 
TEAE 
Treatment-emergent AEs 
tmax 
Time of maximum observed plasma concentration 
WHO 
World Health Organization 

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3. 
INTRODUCTION 
Amlodipine is a third-generation calcium channel blocker that prevents calcium from entering 
myocardial cells and vascular smooth muscle cells, and thus has antihypertension effect. 
Amlodipine in the besylate salt form was developed by Pfizer Laboratories and was approved as 
NORVASC 2.5 mg, 5.0 mg, and 10.0 mg Tablets by the U.S. FDA for the treatment of 
hypertension in 1992 (NDA No. 019787). Generic equivalents of NORVASC have been 
marketed globally since 2007.  
Amlodipine is a 1:1 racemic mixture of S-amlodipine (the levorotatory L-form) and R-
amlodipine (the dextrorotatory D-form). S-amlodipine is the pharmacologically active moiety in 
racemic amlodipine. Clinically, S-amlodipine, at half the dose of amlodipine (2.5 mg vs. 5 mg, 
respectively), has been found to be equivalent to racemic amlodipine in efficacy, safety, and 
tolerability, with less edema, in patients with mild to moderate hypertension. 
Levamlodipine maleate tablets 2.5 mg, a purified S-amlodipine tablet formulation, was approved 
for marketing in China in 2003 (Drug Code 86902770002300) for the treatment of hypertension 
and angina. Levamlodipine maleate tablets 2.5 mg are marketed under the trade name 
Xuanning® in China.  
 
4. 
STUDY OBJECTIVES 
The objectives of this study are (1) to assess the relative bioavailability (BA) of a single oral 
dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine 
Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female 
healthy subjects; and (2) to evaluate food effect on PK profile of Levamlodipine Maleate 
Tablets. 
 
5. 
INVESTIGATIONAL PLAN  
5.1. 
Study Design 
This study consists of 2 parts. Part 1 will be a randomized, open-label, single-dose, two-way 
crossover study to assess the relative BA of 5 mg of levamlodipine maleate tablets from CSPC 
(Test Product) versus 10 mg of Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. 
(Reference Product) after a single oral administration under fasted conditions in male and female 
healthy subjects. Approximately 32 healthy volunteers will be enrolled for Part 1 to obtain 27 
completed subjects. 
Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile 
of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled 
over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will 

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receive a single oral administration of 5 mg levamlodipine maleate tablets from CSPC under a 
high-fat/high-calorie meal that should derive approximately 150, 250 and 500-600 calories from 
protein, carbohydrate and fat, respectively. 
5.2. 
Study Methods 
The detailed timing and scheduling for Part 1 are shown in Table 5-1, Table 5-2. Eligible subject 
will be randomized to receive one of two treatment sequences (RT or TR; R=10 mg of 
NORVASC® and T=5 mg of levamlodipine maleate tablets) according to a randomization 
schedule prepared prior to the start of the study. All study drugs will be administered following 
an overnight fast for approximately 10 hours. 
Eligible subjects will be admitted to the clinical research center (CRU) within 24 hours before 
baseline assessments in Period 1 and will stay at the CRU for 3 nights. A single dose of study 
drug should be taken orally with 240 ml (about 8 fluid ounces) of water at site after being fasted 
overnight, and meal will be allowed around 1 hour after dosing. Subjects should return to the 
CRU on Days 4 till 8 to provide PK samples and to receive study assessments. Serial blood 
samples will be obtained at defined time points within 7 days after dosing in each treatment for 
the measurement of plasma (S)amlodipine and (R)amlodipine concentrations.  
After a wash-out period for at least 14-days since the last dosing, subjects will enter into Period 2 
to receive alternative reference or test drug. Thus, subjects who receive levamlodipine treatment 
in Period 1 will now receive NORVASC® treatment in Period Two, while subjects who receive 
NORVASC® treatment in Period One will now receive levamlodipine treatment in Period 2. The 
same procedure will be performed at approximately same time points as noted for Period 1. 
The detailed timing and scheduling for Part 2 are shown in Table 5-3. Following an overnight 
fast for approximately 10 hours, subjects will eat a high-fat/high-calorie. This meal should derive 
approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively. 
Subjects should start the recommended meal 30 minutes prior to administration of study drug, 
and finish this meal in 30 minutes or less. The study drug should be administered with 240 mL 
(about 8 fluid ounces) of water immediately after the meal. No food should be allowed for at 
least 4 hours post-dose. Water can be allowed as desired except the 1-hour period before and 
after drug administration.  
Subjects will be admitted to the clinical research center (CRU) within 24 hours before drug 
administration and will stay at the CRU for 3 nights. Subjects should return to the CRU on Days 
4 till 8 to provide PK samples and to receive study assessments. Serial blood samples will be 
obtained at defined time points for the measurement of plasma (S)amlodipine and (R)amlodipine 
concentrations.  
Safety and tolerability will be monitored during the study. 

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Table 5-1． Schedule of Procedures for Part 1 - Period 1 
 
Screening 
                         Clinical Research Unit (CRU) 
Clinical Visits 
Day 
(Day -21 to -1) 
Day 0 1 
(Baseline) 
Day 1 
(Dosing) 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
Day 8 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
Physical examination 2 
X 
 
 
 
 
 
 
 
 
X 
Vital signs 3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
X 
X4 
 
 
 
 
 
 
 
X 
Clinical safety tests  
X5 
X 
 
 
 
 
 
 
 
X 
Drug/alcohol test 
X 
X 
 
 
 
 
 
 
 
X 
Pregnancy test 6 
X 
X 
 
 
 
 
 
 
 
 
Admission to CRU 
 
X 
 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
Dose administration 
 
 
X 
 
 
 
 
 
 
 
PK blood samples 7 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
AE & ConMed 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discharge from CRU 
 
 
 
 
X 
 
 
 
 
 
 
1 Baseline.         
 
 
2 Including body weight and height at screen only.  
3 Complete vital sign measurements at screening visit, Day 0 and 0, 24, 96 and 168 hours after dosing. Blood pressure and heart rate only at other time points. Three measurements 
of blood pressure at screening visit and a single measurement at other time points. 
4 Three ECG tests with 3 min interval in between on Day 0. The means of the three ECG tests will be used as baselines. 
5 HIV, hepatitis B & C screen test at screening visit only.      
 
6 Serum test at screening and urine test on Day 0 for females of childbearing potential only. 
7 Pharmacokinetic blood samples will be collected at the following time points: Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 72, 96, 
120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr post dose period and ± 5 min thereafter) 
 
AE = adverse event; ConMed = concomitant medications; CRU = clinical research unit; ECG = electrocardiogram; PK =pharmacokinetics. 

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Table 5-2． Schedule of Procedures for Part 1 - Period 2 
 
 
Wash-out 
Clinical Research Unit (CRU) 
Clinical Visits 
Day 
At least 14 days 
since the last 
dosing 
Day 0 
(Admission) 
Day 1 
(Dosing) 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
Day 8 
Admission to CRU 
 
X 
 
 
 
 
 
 
 
 
Cross-over of treatment 
 
X 
 
 
 
 
 
 
 
 
Physical examination  
 
X 
 
 
 
 
 
 
 
X 
Vital signs 1 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
 
X 
 
 
 
 
 
 
 
X 
Clinical safety tests  
 
X 
 
 
 
 
 
 
 
X 
Drug/alcohol test 
 
X 
 
 
 
 
 
 
 
X 
Pregnancy test 2 
 
X 
 
 
 
 
 
 
 
X 
Dose administration 
 
 
X 
 
 
 
 
 
 
 
PK blood samples 3 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
AE & ConMed 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discharge from CRU 
 
 
 
 
X 
 
 
 
 
 
 
1 Complete vital sign measurements at 0, 24, 96 and 168 hours after dosing. Blood pressure and heart rate only at other time points. Three measurements of blood 
pressure at screening visit and a single measurement at other time points. 
2 Urine test for females of childbearing potential only. 
3 Pharmacokinetic blood samples will be collected at the following time points: Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24,  
36, 48, 72, 96, 120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr post dose period and ± 5 min thereafter) 
 
AE = adverse event; ConMed = concomitant medications; CRU = clinical research unit; ECG = electrocardiogram; PK =pharmacokinetics. 
 

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Table 5-3.  Schedule of Procedures for Part 2 (Food Effect) 
 
Wash-out 
Clinical Research Unit (CRU) 
Clinical Visits 
Day 
At least 14 
days since the 
last dosing 
Day 0 
(Admission) 
Day 1 
(Dosing) 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
Day 8 5 
Admission to CRU 
 
X 
 
 
 
 
 
 
 
 
Physical examination 
 
X 
 
 
 
 
 
 
 
X 
Vital signs 1 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
 
X 
 
 
 
 
 
 
 
X 
Clinical safety tests  
 
X 
 
 
 
 
 
 
 
X 
Drug/alcohol test 
 
X 
 
 
 
 
 
 
 
X 
Pregnancy test 2 
 
X 
 
 
 
 
 
 
 
X 
 High-fat/calorie meal 3 
 
 
X 
 
 
 
 
 
 
 
Dose administration 
 
 
X 
 
 
 
 
 
 
 
PK blood samples 4 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
AE & ConMed 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discharge from CRU 
 
 
 
 
X 
 
 
 
 
 
 
1 Complete vital sign measurements on Day 0 and 0, 24, 96 and 168 hours after dosing. Blood pressure and heart rate only at other time points.  
2 Urine test for females of childbearing potential only. 
3  The meal should be started 30 minutes prior to administration of study drug, and finished in 30 minutes or less 
4 Pharmacokinetic blood samples will be collected at the following time points: Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24,  
36, 48, 72, 96, 120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr post dose period and ± 5 min thereafter) 
5 End-of the study or early termination.  
 
 
AE = adverse event; Con Med = concomitant medications; CRU = clinical research unit; ECG = electrocardiogram; PK =pharmacokinetics. 
 

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5.3. 
Number of Subjects 
The planned total subject number is about 32 healthy volunteers for Part 1 in order to obtain 27 
completed subjects. Subjects who have completed Part 1 will be rolled over to Part 2 to assess 
food effect on the PK profile of levamlodipine maleate tablets. 
5.4. 
Treatment Assignment 
Subjects receive the study treatments in Part 1 and Part 2 according to the following scheme 
Part 1 
(BE under 
fasted 
conditions) 
Treatment A 
(Test Product) 
A single dose of one 5 mg levamlodipine maleate tablet 
under fasted conditions (manufactured by CSPC Ouyi 
Pharmaceutical Co., Ltd., Hebei, China) 
Treatment B 
(Reference 
Product) 
A single oral dose of one 10 mg NORVASC® (amlodipine 
besylate) tablet under fasting conditions (manufactured by 
Pfizer Inc., New York, NY) 
The randomly assigned treatment sequences will be: 
• Sequence 1 (AB): Treatment A in Period 1; Treatment B in Period 2 
• Sequence 2 (BA): Treatment B in Period 1; Treatment A in Period 2 
Part 2 
(Food effect) 
Test Product 
under fed 
condition 
A single dose of one 5 mg levamlodipine maleate tablet 
under fed conditions (manufactured by CSPC Ouyi 
Pharmaceutical Co., Ltd., Hebei, China) 
Subjects should take a high-fat / high-calorie meal 
approximately 30 minutes prior to administration of the 
test product. 
5.5. 
Criteria for Study Termination 
The Principal Investigator has the right to terminate the study in the interest of subject safety and 
welfare in consultation with CSPC Pharma. CSPC Pharma reserves the right to terminate or 
amend the study at any time for administrative reasons or if continuation of the protocol would 
present a potential safety risk to the subjects. 
 
6. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
6.1. 
Subject Inclusion Criteria 
To participate in the study, subjects must meet all the following eligibility criteria at screening or 
admission: 
1. Are capable of giving informed consent and complying with study procedures; 

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2. Are between the ages of 18 and 45 years old, inclusive; 
3. Women of childbearing potential (WOCBP) must have a negative pregnancy test at 
Screening and be practicing a medically acceptable method of contraception with an annual 
failure rate of less than 1% during the study and 60 days after discontinuation of study 
treatment. Women are considered not childbearing potential if they are > 1 year 
postmenopausal or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy tubal ligation). If serum βHCG is the standard of care, then this value can be 
used to determine eligibility 
4. Considered healthy by the Principal Investigator, based on a detailed medical history, full 
physical examination, clinical laboratory tests, 12-lead ECG and vital signs;  
5. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 
months before screening;  
6. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg; 
7. Willing and able to adhere to study restrictions and to be confined at the clinical research 
center. 
6.2. 
Subject Exclusion Criteria 
Subjects will be excluded from study entry if any of the following exclusion criteria are present 
at screening or admission: 
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, 
hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid 
metabolism disorders, or drug hypersensitivity; 
2. Subjects with a mean systolic blood pressure of three measurements >140 mmHg, or a mean 
diastolic blood pressure of three measurements >90 mmHg at screening. Blood pressure will 
be measured at sitting position. 
3. Known or suspected malignancy; 
4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface 
antigen (HBsAg), or hepatitis C virus (HCV);  
5. A history of seizure. However, a history of febrile seizure is allowed; 
6. Positive pregnancy test result, or plan to become pregnant if female; 
7. A hospital admission or major surgery within 30 days prior to screening; 
8. Participation in any other investigational drug trial within 30 days prior to screening; 
9. DSM-V substance use disorder within 6 months prior to screening; 
10. A positive result for alcohol or drugs of abuse at screening or admission; 
11. Tobacco use within 6 months prior to screening; 
12. An unwillingness or inability to comply with food and beverage restrictions during study 
participation; 
13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood 
products) or acute loss of blood during the 90 days prior to screening; 
14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (including 
St John’s Wort, herbal teas, garlic extracts) within 14 days prior to dosing; 

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15. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a 
significant history of risk of suicide or homicide; 
16. A history of intolerance or hypersensitivity to amlodipine or any excipients; 
17. An unwillingness of male participants to use appropriate contraceptive measures if engaging 
in sex intercourse with a female partner of childbearing potential during the study and 60 
days after discontinuation of study treatment. Sexual intercourse with pregnant or lactating 
women is prohibited。  
6.3. 
Prior and Concomitant Medication and Substance 
Illicit drug use and abuse of alcohol is prohibited prior to or during the study.  
Subjects may not use tobacco containing products within 6 months prior to screening and at any 
time during the study. 
The use of prescription medications or OTC products, including herbal product (e.g., St John’s 
Wort, herbal teas, garlic extracts) is prohibited within 14 days prior to dosing. 
After the subjects are enrolled and during the entire study period, subjects must adhere to the 
following prohibitions: 
• Consumption of alcohol is not permitted within 48 hours prior to dosing and during the 
study 
• Consumption of caffeine containing food or beverages is not permitted within 24 hours 
prior to dosing 
• Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing  
• No administration of any prescription drugs, unless necessary for the treatment of an AE 
in the opinion of the Investigator. 
All prescription medications and OTC products, including herbal products, taken in the 30 days 
prior to dosing or during the study period will be documented in the subject’s source 
documentation and the case report form (CRF). 
6.4. 
Subject Withdraw Criteria 
Subjects will be informed that they have the right to withdraw from the study at any time for any 
reason without prejudice to their medical care. The Investigator also has the right to withdraw 
subjects from the study if it is in the best interest of the subject, or if the subject experiences an 
adverse event that warrants premature withdrawal. 
Subjects may be withdrawn from the study if they: 
• Have entered the study in violation of the protocol 
• Use or require the use of prohibited concomitant medication(s) 
• Are non-compliant with study procedures 
• Experience an AE that warrants premature withdrawal 

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All treated subjects, should be followed according to the Schedule of Procedures. All subjects, 
even those who have discontinued prematurely, should have all evaluations for the End-of-Study 
visit performed, if possible. All procedures should be documented in the subject source 
documents and CRF. For all subjects who withdraw prematurely, the Investigator will indicate 
one of the following reasons for withdrawal on the CRF: 
• Adverse event 
• Death 
• Protocol violation 
• Lost to follow-up 
• Subject’s decision 
• Other (reason to be specified by the Investigator) 
In case of subjects’ discontinuation from the study due to an AE, such subjects will be closely 
monitored until the resolution or stabilization of the AE. The Investigator should document the 
reason for discontinuation in the source documentation and CRF. 
In the event that a subject withdraws participation from the study early, early withdrawal should 
be documented by the Investigator (or designee) in the appropriate CRF pages and source 
documents when confirmed. 
 
7. 
STUDY PROCEDURES 
The following sections describe in detail all study procedures. The schedule of procedures is 
presented in Table 5-1，Table 5-2，Table 5-3. 
7.1. 
Part 1- Period One 
7.1.1. Screening (Day -21 to -1) 
Subjects will report to the CRU for a screening visit between Day -21 and Day -1 prior to the 
dosing. The following information and procedures will be performed and documented as part of 
the screening assessments: 
• 
Prior to the performance of any study-related activities or evaluations, the subject must be 
thoroughly informed about all aspects of the study, including scheduled visits and 
activities. Each subject will sign the study-specific consent form prior to any screening 
procedures. A signed copy of the informed consent form (ICF) will be given to each 
consenting subject and another signed copy will be retained in the subject’s study 
records. 
• Medical history, including review of prior and ongoing medications taken in previous 30 
days 
• Physical examination including height and weight measurements. BMI will be calculated 

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• Vital sign measurements including blood pressure (three measurements), heart rate, 
respiratory rate and temperature. Subjects should be resting for at least 5 minutes prior to 
measurement. Vital signs will be measured in sitting position. 
• A single 12-lead ECG (subject should be resting for at least 5 min prior to recording). 
ECG will be recorded in supine position 
• Overnight fasting blood sample collection for safety tests as defined in Appendix A. HIV, 
and hepatitis B and C evaluations will be done at screening visit only 
• Drug/alcohol test 
• Serum pregnancy test at screening for females of childbearing potential.  
Compliance with inclusion criteria and exclusion criteria will be verified against information 
collected and documented in the source documents and the CRF. Laboratory results obtained at 
screening will be used to verify eligibility. 
Examples of contraception methods for participant or partner may include vasectomized partner 
(at least 6 months prior to dosing); intrauterine device; condom with spermicidal gel, foam, 
cream, film, or suppository; diaphragm with spermicidal gel, foam, cream, film, or suppository; 
or cervical cap with spermicidal gel, foam, cream, film, or suppository. A female of 
non-childbearing potential must have had at least 12 continuous months of natural (spontaneous) 
amenorrhea, follicle-stimulating hormone level > 40 mIU/mL at Screening, or have had surgical 
bilateral oophorectomy or hysterectomy > 6 weeks prior to Screening.  
Once all inclusion criteria are met, exclusion criteria ruled out, and laboratory measurements 
obtained, eligible subjects will be scheduled for the admission (Day 0) visit within 21 days of 
screening. 
7.1.2. Baseline (Day 0) 
Subjects will be admitted to the CRU on Day 0 and remain sequestered at the CRU until the 
collection of the PK sample of 48 hours after dosing.  
On arrival at the clinical research unit, all subjects will undergo the following assessments:  
• Vital signs including blood pressure, heart rate, respiratory rate and temperature 
• Three 12-lead ECGs will be recorded with 3-min interval at this visit. The means of the 
three ECGs will be used as the baselines.  
• Overnight fasting blood sample collection for safety tests 
• Drug/alcohol test 
• Urine pregnancy test for females of childbearing potential 
• Admission to the CRU for eligible subjects 
• Assessment of AEs and concomitant medications 
Enrolled patients will be fasted from 10 pm the day prior to dosing until approximately 4 
hours after administration the next day (dosing day). Water intake will be permitted until 6 
am of the dosing day. 

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7.1.3. Dosing (Day 1) 
The following assessments and procedures will be performed and documented at this visit: 
• Vital signs. Prior to dosing, blood pressure, heart rate, respiratory rate and temperature 
will be measured. For all other time points, only blood pressure and heart rate will be 
measured  
• Randomization to treatment 
• Administration of study drug. Dose will be administered orally with 240 mL of room 
temperature water in an upright position under fasting conditions at approximately 8 am. 
Subjects should not drink water and need to maintain an upright position for 2 hours after 
the administration of the study drug. Lunch will be served at approximately 4 hours after 
the administration and dinner as the standard meal at approximately 10 hours post dose. 
If needed, evening snack can be provided. Time of administration will be documented for 
both study drug and meals.  
• Pharmacokinetic blood samples will be collected at the following time points: 
Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 
72, 96, 120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr 
post dose period and ± 5 min thereafter) 
• Assessment of AEs and concomitant medications. 
All doses of study drug will be administered orally under fasting conditions at approximately 8 
am on the day of dosing. Subjects will be closely supervised and within sight of study personnel 
within 8 hours after dosing. Actual times for dosing, each assessment and meals (start times for 
meals on the day of dosing) must be recorded. Any deviations from the protocol-specified 
administration schedule will also be documented. 
7.1.4. Days 2 through 7 
The following assessments and procedures will be performed and documented. 
• Daily vital sign measurements 
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.1.3 and footnote of Table 5-1 
• Assessment of AEs and concomitant medications daily 
• Discharge from CRU on Day 3 after the 48-hour after dosing PK sample is obtained. 
Subjects will be remined to return to CRU at defined time to provide PK sample and to 
receive study assessments 
7.1.5. Day 8 
The following assessments and procedures will be performed and documented. 
• Physical examination  
• Vital sign measurements 

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• A single 12-lead ECG  
• Overnight fasting blood sample collection for safety tests 
• Drug and alcohol test  
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.1.3 and footnote of Table 5-1 
• Assessment of AEs and concomitant medications daily 
7.2. 
Part 1- Period Two 
After a wash-out period for at least 14-day since the last dosing, subjects will be evaluated for 
their eligibility for Period Two. Eligible subjects will crossover to the alternative reference or 
test drug. Thus, subjects who receive levamlodipine treatment in Period One will now receive 
NORVASC® treatment in Period Two, while subjects who receive NORVASC® treatment in 
Period One will now receive levamlodipine treatment in Period Two. The same procedure will 
be performed at the same time points as noted for Period One. 
7.2.1. Admission (Day 0) 
The following assessments and procedures will be performed and documented: 
• Admission to CRU 
• Cross-over to treatment 
• Physical examination 
• Vital signs 
• A single 12-lead ECG record 
• Overnight fasting blood sample collection for safety tests 
• Drug/alcohol test 
• Urine pregnant test for females of childbearing potential 
• Assessment of AEs and concomitant medications. 
7.2.2. Dosing (Day 1) 
The following assessments and procedures will be performed and documented: 
• Vital signs. Prior to dosing, blood pressure, heart rate, respiratory rate and temperature 
will be measured. For all other time points, only blood pressure and heart rate will be 
measured  
• Administration of study drug. Dose will be administered orally with 240 mL of room 
temperature water in an upright position under fasting conditions at approximately 8 am. 
Subjects should not drink water and need to maintain an upright position for 2 hours after 
the administration of the study drug. Lunch will be served at approximately 4 hours after 
the administration and dinner as the standard meal at approximately 10 hours post dose. 
If needed, evening snack can be provided. Time of administration will be documented for 
both study drug and meals.  
• Pharmacokinetic blood samples will be collected at the following time points: 

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Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 
72, 96, 120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr 
post dose period and ± 5 min thereafter) 
• Assessment of AEs and concomitant medications. 
All doses of study drug will be administered orally under fasting conditions at approximately 8 
am on the day of dosing. Subjects will be closely supervised and within sight of study personnel 
within 8 hours after dosing. Actual times for dosing, each assessment and meals (start times for 
meals on the day of dosing) must be recorded. Any deviations from the protocol-specified 
administration schedule will also be documented. 
7.2.3. Days 2 through 7 
The following assessments and procedures will be performed and documented. 
• Daily vital sign measurements 
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.2.2 and footnote of Table 5-2 
• Assessment of AEs and concomitant medication daily 
• Discharge from CRU on Day 3 after the 48-hour after dosing PK sample is obtained. 
Subjects will be remined to return to CRU at defined time to provide PK sample and to 
receive study assessments 
7.2.4. Day 8 
The following assessments and procedures will be performed and documented. 
• Physical examination 
• Vital sign measurements 
• A single 12-lead ECG  
• Overnight fasting blood sample collection for safety tests  
• Drug/alcohol test  
• Urine pregnancy test for females of childbearing potential 
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.2.2 and footnote of Table 5-2 
• Assessment of AEs and concomitant medication daily 
• Discharge from the CRU 
7.3. 
 Part 2 (Food Effect) 
7.3.1. Admission (Day 0) 
Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at 
least 14-days since the last dosing to assess food effect on the PK profile of levamlodipine 
maleate tablets from CSPC. Eligible subjects will be admitted to the CRU on Day 0 and remain 
sequestered at the CRU until the collection of the 48-hour PK sample after dosing.  

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On arrival at the clinical research unit, all subjects will undergo the following assessments:  
• Physical examination 
• Vital signs including blood pressure, heart rate, respiratory rate and temperature 
• A single 12-lead ECG 
• Overnight fasting blood sample collection for safety tests 
• Drug/alcohol test 
• Urine pregnancy test for females of childbearing potential 
• Admission to the CRU 
• Assessment of AEs and concomitant medications 
Enrolled patients will be fasted from 10 pm the day prior to dosing until approximately 4 hours 
after administration the next day (dosing day). Water intake will be permitted until 6 am of the 
dosing day. 
7.3.2. Dosing (Day 1) 
The following assessments and procedures will be performed and documented at this visit: 
• Vital signs. Prior to dosing, blood pressure, heart rate, respiratory rate and temperature 
will be measured. For all other time points, only blood pressure and heart rate will be 
measured  
• High-fat/high-calorie meal. Following an overnight fast of at least 10 hours, subjects 
should start the recommended meal 30 minutes prior to administration of the drug 
product. Study subjects should eat the a high-fat / high-calorie meal in 30 minutes or less. 
This meal should derive approximately 150, 250 and 500-600 calories from protein, 
carbohydrate and fat, respectively. Subjects should receive standardized meals scheduled 
at the same time in each period of the study. 
• Administration of study drug. Dose will be administered orally with 240 mL of room 
temperature water in an upright position under using meal conditions at approximately 8 
am. No food should be allowed for at least 4 hours post-dose. Water can be allowed as 
desired except for one hour before and after drug administration. Subjects should receive 
standardized meals scheduled at the same time in each period of the study. 
• Pharmacokinetic blood samples will be collected at the following time points: 
Pre-dose (within 30 min prior) and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 
72, 96, 120, 144, and 168 hours after dosing (acceptable windows: ± 2 min for 0 to 2-hr 
post dose period and ± 5 min thereafter) 
• Assessment of AEs and concomitant medications. 
Subjects will be supervised and within sight of study personnel within 8 hours after dosing. 
Actual times for dosing, each assessment and meals (start times for meals on the day of dosing) 
must be recorded. Any deviations from the protocol-specified administration schedule will also 
be documented. 

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7.3.3. Days 2 through 7 
The following assessments and procedures will be performed and documented. 
• Daily vital sign measurements 
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.3.2 and footnote of Table 5-3 
• Assessment of AEs and concomitant medications daily 
• Discharge from CRU on Day 3 after the 48-hour after dosing PK sample is obtained. 
Subjects will be remined to return to CRU at defined time to provide PK sample and to 
receive study assessments 
7.3.4. Day 8 
The following assessments and procedures will be performed and documented. 
• Physical examination 
• Vital sign measurements 
• A single 12-lead ECG 
• Overnight fasting blood sample collection for safety tests  
• Drug/alcohol test  
• Urine pregnant test for females of childbearing potential  
• Pharmacokinetic blood sample collections (acceptable windows: ± 5 min). See PK 
timepoints in section 7.3.2 and footnote of Table 5-3 
• Assessment of AEs and concomitant medications daily 
7.4. 
Early Withdrawal Visit 
In the event that a subject discontinues study participation at any time prior to the final End-of-
Study visit, if possible, the subject should complete all follow-up assessments, as described for 
Day 8. The reason for discontinuation must be fully documented in the subject’s source 
documentation and in the CRF. 
 
8. 
TREATMENT OF SUBJECTS 
8.1. 
Methods of Assigning Subjects in Part 1 
Subject treatment assignment will be based on a generated randomization scheme with a ratio of 
1:1 (test: reference). Each treatment group will have 16 subjects randomized to receive either test 
drug or reference drug. 
8.2  
Methods of Assigning Subjects in Part 2 
All subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for 
at least 14 days since the last dosing to assess food effect on the PK profile of levamlodipine 
maleate tablets. Subjects will receive a single oral administration of study drug under a high-fat / 

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high-calorie meal. This meal should derive approximately 150, 250 and 500-600 calories from 
protein, carbohydrate and fat, respectively. 
 
9. 
STUDY DRUG MATERIALS AND MANAGEMENT 
9.1. 
Study Drug Packaging and Labeling 
Test and reference drugs will be packaged in bottles and labeled according to applicable 
regulatory requirements. The label for study drugs will include at least the following 
information: 
• Name and address of sponsor 
• Protocol number of other identifier to reference the study 
• Storage conditions 
The clinical site pharmacist or designee will prepare the study drug according to the 
randomization scheme, maintain the drug packaging and labeling log. 
9.2. 
Study Drug Storage and Accountability 
All investigational drug supplies will be stored in a secure, locked area, under the responsibility 
of the Investigator or other authorized individual. 
The Investigator or designee must maintain accurate records of the receipt of all study drug, 
including date received, lot number, expiration date if applicable, amount received, condition of 
the package and the disposition of all study drug. 
Current dispensing records will also be maintained including the date and amount of study drug 
dispensed and the identity of the subject receiving the study drug. 
9.3. 
Study Drug Handling and Disposal 
All unused study drug and supplies must be returned to CSPC Pharma or disposed according to 
sponsor’s instruction after the study is completed and the drug accountability log is reconciled. 
 
10. 
PHARMACOKINETICS ASSESSMENTS 
Plasma concentrations of (S)amlodipine and (R)amlodipine will be measured with validated 
methods under GLP. 
Guidelines for preparing, labeling, storing and shipping plasma samples for bioanalytical 
analyses will be provided in a separate manual. 

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10.1. Blood Sample Collection 
A total of 23 blood samples will be collected at the following time points: within 30 min prior to 
dosing and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 72, 96, 120, 144, and 168 
hours after each dosing.  
Contents of tube will be mixed thoroughly with gentle inversion (a minimum of 8 times) to mix 
the anti-coagulant. Total volume of blood collected for determination of study drug 
concentration will be approximately 100 mL (16 × 6mL) for each subject. 
10.2. Sample Storage and Shipping 
All blood samples will be stored on ice or at 4°C for no more than 30 minutes until plasma is 
harvested. Blood samples will be centrifuged in a refrigerated centrifuge (approximately 4°C) at 
~2000 g for 10 minutes. The harvested plasma will be split into two approximately equal aliquots 
and stored in 2 mL or appropriate size cryovial tubes. The plasma samples will be frozen within 
approximately 60 minutes of harvesting and stored at –70°C or –80°C pending shipment for drug 
analysis. 
10.3. Specimen Labeling 
Labels will be affixed to the cryovial and polypropylene tubes in a manner that will prevent the 
label from being detached or smeared after being wet or freezing. The tube labels will follow the 
instruction to be provided in the PK Lab Manual. 
The site will provide a sample inventory page, listing the information above for each sample. 
The sample inventory page will also include the treatment and study part/period for each series 
of tubes. 
10.4. Sample Shipping Instructions 
All plasma samples will be kept frozen and shipped on dry ice by the same day or overnight 
courier to the designated laboratory.  
Plasma samples will be sent to the designated laboratory in two separate shipments. The first 
shipment of samples (the primary aliquot of each sample) will be shipped based on the schedule 
specified in the PK Lab Manual. The second aliquot of each sample will be shipped after 
notification from the designated laboratory. 
10.5. Bioanalytical Methodology 
Plasma samples will be analyzed by the designated bioanalytical lab using validated methods of 
liquid chromatographic separation with tandem mass spectrometric detection (LC-MS/MS) for 
concentrations of (S)amlodipine and (R)amlodipine. 
10.6. PK Parameters 
The plasma concentration time data for (S)amlodipine and (R)amlodipine will be analyzed using 
non-compartmental methods. Actual dosing and sampling times will be used for analyses. The 

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primary PK parameters of interest are: Cmax, tmax, tlag, t1/2, λz, MRTinf, AUClast, AUCinf, AUCextrap, 
Cl/F and Vd/f. Additional parameters may be estimated and reported, as appropriate. 
 
11. 
ASSESSMENT OF SAFETY 
For specific timing of assessments, please see Table 5-1, Table 5-2, Table 5-3 for Schedule of 
Procedures. 
11.1.1. Medical History 
Demographic characteristics (age, sex, race and ethnicity) will be collected at screening visit. 
Medical history will be reviewed and collected at screening visit. 
11.1.2. Vital Signs 
Vital signs, including blood pressure, pulse rate, respiratory rate, and oral temperature, will be 
measured at the screening and other visits. Subjects should be resting for at least 5 minutes prior 
to measurement. Vital signs will be measured in sitting position. 
Vital signs may be repeated for clinically significant abnormal vital signs at the discretion of the 
Investigator.  
11.1.3. Physical Examination 
Physical examinations will be performed by qualified personnel at the screening and few other 
visits. At the screening visit, height (centimeters) and weight (kilograms) will be measured and 
BMI will be calculated. All abnormal findings will be documented in the source documentation 
and the CRF. 
11.1.4. Electrocardiogram 
Standard resting 12-lead ECGs will be performed at multiple visits. All ECGs will be performed 
after the subject has rested for at least 5 minutes. 
At baseline, three ECGs will be recorded with approximately 3-min interval. The means of the 
three ECGs will be used as baselines.  
Multiple parameters such as HR, PR, RR, QRS, QT and QTcB or QTcF will be measured. 
Post-dose ECGs must be evaluated for safety by the Investigator or his/her designee. The final 
conduction intervals entered into the CRF will be those generated by the ECG machine, unless 
deemed significantly inaccurate by the review performed by the Investigator or designee. In 
these cases, the over-read intervals will be documented in the CRF. The Investigator will also 
record an overall assessment of the ECG. Clinically significant abnormal ECGs may be repeated 
at the discretion of the Investigator. 

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11.1.5. Clinical Laboratory Assessments 
Hematology, blood chemistry, and urinalysis evaluations will be performed at screening and few 
other visits. The list of clinical laboratory assessments is included in Appendix A. Subjects 
should be fasted overnight prior to blood sample collection for safety tests. 
The total volume of blood collected for safety laboratory assessments will be approximately 
70 mL. 
The results of clinical laboratory tests conducted at the screening visit must be assessed by the 
Investigator to determine each subject’s eligibility for participation in the study. The Investigator 
should signify review of the laboratory reports by signing and dating the report. If subjects’ 
values are out of range and the Investigator deems the out of range value is clinically significant, 
the Investigator must discuss and agree upon individual cases with CSPC Pharma’s Medical 
Monitor prior to enrollment. 
Any significant abnormalities should be fully investigated. Whenever possible, the etiology of 
the abnormal findings will be documented on the CRF. Laboratory results with clinically 
significant abnormal values may be repeated for verification. Additional tests and other 
evaluations required to establish the significance or etiology of an abnormal result or to monitor 
the course of an AE should be obtained when clinically indicated. In particular, if a clinically 
significant abnormal result is observed that is not resolved by the final study visit, repeat tests 
will be performed if possible and resolution or stability of the abnormality will be recorded in the 
source documentation. 
Any clinically significant laboratory abnormalities that are either serious (e.g., require medical 
intervention or result hospital admission) or unexpected will be promptly reported to the CSPC 
Pharma’s representative. Any additional relevant laboratory results obtained by the Investigator 
during the course of this study will be reported to CSPC Pharma. 
Virus serology (HIV, and hepatitis B and C) will be assessed at the screening visit only, and 
must be negative to qualify enrollment. 
Drug and alcohol tests will be conducted at the screening visit and on Day -1. Results must be 
negative to qualify enrollment prior to dosing. 
Serum pregnancy test will be performed at screening visit, and urine pregnancy test on Day -1 
for female subjects only. 
11.2. Adverse Events 
Adverse events will be recorded beginning immediately after the ICF is signed. Subjects will be 
instructed to report AEs during the study and staff will query subjects regarding AEs throughout 
the study. The Investigator (and/or designee) must document all AEs reported by the subject 
from the time subjects give consent through completion of the End-of-Treatment visit. Any 
subject who is withdrawn from the study due to an AE shall be followed until the event has 

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resolved or stabilized, and the Investigator will document available follow-up information on the 
subject’s source documentation and CRF. 
11.2.1. Definitions of Adverse Events 
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of medicinal (investigational) product, 
whether or not related to the medicinal (investigational) product. An AE is any symptom, sign, 
illness, or experience that develops or worsens in severity during the course of the study. 
Adverse events reported after consent but before the first dose of study drug are still to be 
documented by the Investigator but will be considered non-treatment-emergent AEs. Adverse 
events will be considered treatment emergent if the onset date is after the first dose of study drug. 
The severity of each AE will be graded by the Investigator according to the following criteria:  
• Mild: awareness of sign or symptom, but easily tolerated 
• Moderate: discomfort sufficient to cause interference with normal activities 
• Severe: incapacitating, with inability to perform normal activities 
Inter-current illnesses or injuries should be regarded as AEs. Abnormal results of laboratory tests 
or diagnostic procedures are considered to be AEs if the abnormality: 
• Is associated with clinical signs or symptoms 
• Is considered by the Investigator to be of clinical significance 
• Results in study withdrawal 
• Fulfills any of the criteria for an SAE, as described in this section 
• Requires intervention or further evaluation to determine the etiology of the abnormality 
and/or assess the risk to the subject 
• Requires treatment 
An SAE is any untoward medical occurrence at any dose that: 
• Results in death 
• Is life threatening 
• Requires inpatient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect 
• Is a medically important event that may jeopardize the subject or may require medical or 
surgical intervention to prevent one of the other outcomes listed above 
The term “life threatening” in the definition of “serious” refers to an event in which the subject 
was at risk of death at the time of the event; it does not refer to an event that hypothetically might 
have caused death if it were more severe. Death is an outcome of an event. The event that 
resulted in death should be recorded and reported on the SAE form and documented in the CRF. 

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The Investigator must assess the relationship between the AE and the study drug by using the 
following definitions: 
• Probably related: The AE follows a reasonable temporal sequence from administration of 
the medication; OR the AE follows a known pattern of or response to the study drug; OR 
an alternative explanation (e.g., concomitant disease, environmental factors, and/or 
concomitant medication) is less likely than attribution to the study drug; OR the AE 
diminishes or disappears upon cessation or reduction of dose of medication; OR the AE 
reappears upon re-administration of the medication. 
• Possibly related: The AE follows a reasonable temporal sequence from administration of 
the medication; OR an alternative explanation (e.g., concomitant disease, environmental 
factors, and/or concomitant medication) is inconclusive, thus the causal relationship 
cannot be excluded; OR the AE diminishes or disappears upon cessation or reduction of 
dose of medication. 
• Not related: The AE does not follow a reasonable temporal sequence from administration 
of the medication; OR the AE does not follow a known pattern of or response to the study 
drug; OR the AE can be attributed to another factor (e.g., concomitant disease, 
environmental factors, and/or concomitant medication). 
11.2.2. Adverse Events of Special Interest 
The following adverse events of special interest that are considered to be associated with the 
levamlodipine maleate tablets will be collected:  
Common adverse reactions:  
• 
Autonomic nerves system: flushing  
• 
Body as a Whole: Fatigue  
• 
Cardiovascular, general: edema  
• 
Central and peripheral nervous system: Headache, Dizziness  
• 
The gastrointestinal tract: abdominal pain, nausea Heart rate/rhythm: palpitations 
Psychological: sleepiness  
• 
In clinical trials found no clinical laboratory abnormalities associated with this product.  
Rare adverse reactions in post-marketing experience:  
• 
 Autonomic nerves system: dry mouth, perspiration  
• 
Body as a Whole: weakness, back pain, body discomfort, pain, weight increase/decrease 
• 
Cardiovascular, general: hypotension, syncope 
• 
 Central and peripheral nervous system: high muscle tension, hypesthesia/paresthesia, 
peripheral neuropathy, tremor  
• 
Endocrine: hyperplasia of mammary glands  
• The gastrointestinal tract: constipation: dyspepsia (including gastritis), gingival hyperplasia, 
pancreatitis, vomiting  

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• Metabolic/nutritional: hyperglycemia Musculoskeletal: arthralgia, muscle cramps pain, 
muscle pain 
• Platelet/bleeding and clotting: purpura, thrombocytopenic purpura 
• Psychological: impotence, insomnia, mood changes  
• Respiratory system: cough, dyspnea  
• Dermatologic: baldness, epichrosis 
• Special feeling: taste disorder, tinnitus 
• Urinary system: frequent micturition 
• blood vessels (extracardiac) : vasculitis 
• Vision: visual disturbance  
• White blood cells/reticuloendothelial system: leucopenia 
There have been rare reports of anaphylaxis caused by amlodipine, including pruritus, rash, 
vasogenic edema and erythema multiforme.  
11.2.3. Recording Adverse Events 
All AEs (regardless of seriousness or relationship to study drug) including those from the time of 
consent to the End-of-Treatment visit are to be recorded in the subject’s source documents and 
on the corresponding page(s) in the CRF. Whenever possible, symptoms, signs, and laboratory 
abnormalities should be grouped as a single syndrome or diagnosis. The Investigator should 
specify the date of onset, intensity, action taken with respect to study drug, corrective 
treatment/therapy given, outcome and his/her opinion as to whether there is a reasonable 
possibility that the AE was caused by the study drug, according to the definitions noted in 
Section 11.2.1. All medications administered to treat an AE must be recorded in the subject’s 
source documentation and documented in the CRF. 
11.2.4. Reporting of Serious Adverse Events 
Reporting of SAEs will be conducted in accordance with the appropriate regulatory guidelines. 
All SAEs that occur from the time of consent to the End-of-Study visit must be reported, whether 
or not the event is considered associated with the study drug. The Investigator must complete the 
SAE Reporting Form and submit it by fax with other relevant source documentation to CSPC 
Pharma within 24 hours of awareness of the event. 
The Investigator must also provide with urgent priority (upon receipt of a request) other relevant 
documentation (e.g., copies of diagnostic test results, hospital discharge summary, and/or 
autopsy report) and send this information by fax to CSPC Pharma. 
All SAEs must be recorded in the subject’s source documentation and documented in the CRF. 
Medications administered in association with the SAE must be documented in the CRF and in 
the subject’s source documentation. The Investigator must also promptly notify the Institutional 
Review Board (IRB) /Independent Ethics Committee (IEC) of SAEs, including any follow-up 
information, in accordance with local institutional policy and applicable regulatory requirements. 

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Regulatory authorities will be notified of any AE associated with the use of the study drug that is 
both serious and unexpected, in accordance with the appropriate local regulatory guidelines. 
Notification of the event will be made by written, expedited safety report. 
11.2.5. Adverse Event Follow-up 
The Investigator should take all appropriate measures to ensure the safety of the subjects, 
including referral to a specialist if indicated. The Investigator should follow up on the outcome 
of any AE until the event has resolved or stabilized. 
This implies that follow-up may continue after the subject discontinues from the study and that 
additional information may be requested. 
Any SAE brought to the attention of the Investigator within 30 days after cessation of study drug 
and considered by him/her to be caused by the study drug with a reasonable possibility, should 
be reported through the SAE reporting process. 
 
12. 
STATISTICAL METHODOLOGY 
12.1. Sample Size Determination 
Based on an approximate CVB of 20%, a CVW is calculated to be 14% for Cmax and 11% for 
AUC0-∞, respectively. Thus, an N value of approximately 18 completed subjects for AUC (%CV 
rounded off to 10%), an N value (interpolated) of approximately 27 completed subjects would be 
required for the proposed bioequivalence study. With an estimated drop-out rate of 20% in this 
cross-over study, approximately 32 subjects will be enrolled. 
12.2. Analysis Population 
The Safety Population will be defined as all subjects who receive at least one dose of study drug. 
The Pharmacokinetic Population will be defined as all subjects who receive active drug, have no 
major protocol violations, and have sufficient pharmacokinetic data to obtain reliable estimates 
of the key pharmacokinetic variables. 
12.3. Pharmacokinetics 
Pharmacokinetic parameters described in Section 10 will be calculated using standard non-
compartmental methods and validated software. Individual and mean (SD) concentration time 
profiles will be presented graphically. All pharmacokinetic parameters will be summarized by 
treatment (dose group), using descriptive statistics (e.g., n, arithmetic mean, SD, geometric 
mean, median, and coefficient of variation).  
Additional details regarding the pharmacokinetic analyses will be presented in the Statistical 
Analysis Plan. 

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Food effect will be evaluated based on AUC0-t, AUC0-inf and Cmax of (S)amlodipine and will be 
determined by the changes of log-transformed PK parameters under fasting conditions and fed 
conditions. 
12.4. Demographic Characteristics 
Demographic characteristics will be summarized for the subjects enrolled in the study using 
descriptive statistics. 
An attempt will be made to enroll similar numbers of men and women in each dose group. 
12.5. Exposure to Study Drug 
Each subject’s exposure to study drug will be summarized using descriptive statistics, i.e., the 
number of subjects exposed to each dose. 
12.6. Concomitant Medications 
Concomitant medications will be coded using the World Health Organization (WHO) Enhanced 
dictionary. 
12.7. Safety Analyses 
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes 
in subjects’ physical examination findings, ECGs, vital signs, clinical laboratory results. Safety 
variables will be tabulated and presented for all subjects in the Safety Population. Data will be 
summarized by treatment. Adverse events will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) for preferred term and system organ class, listed by subject. 
Treatment-emergent AEs (TEAEs) will be summarized by treatment, where treatment-emergent 
is defined as any event not present prior to the initiation of the treatments or any event already 
present that worsens in either intensity or frequency following exposure to the treatments. All 
AEs will be summarized by relationship to study drug and by intensity. 
Deaths, SAEs, and AEs resulting in study discontinuation will be tabulated and detailed in 
narratives. 
If adequate data are available, an analysis will be performed for PK profile (e.g., Tmax) in 
conjunction with time to occurrence of adverse events.  
Change from baseline, defined as time of admission to the CRU (Day 0), in clinical laboratory 
parameters, 12 lead ECGs, and vital sign parameters will be summarized by treatment and study 
period. 
Additional safety analyses may be defined in the Statistical Analysis Plan. 

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13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
13.1. Study Monitoring 
At regular intervals during the study, the site will be contacted through monitoring visits, letters, 
and telephone calls by a representative to review study progress, Investigator and subject 
compliance with study protocol requirements, and any emergent problems. During monitoring 
visits, the following points will be reviewed in accordance with all applicable regulatory 
requirements and SOPs: original medical records and other source documents, the Investigator 
site file, screening logs, subject informed consent, subject recruitment and follow-up, SAE 
documentation and reporting, documentation and reporting of endpoints, study drug allocation, 
subject compliance with the study drug regimen, study drug accountability, concomitant therapy 
use, and quality of data. In addition, other required regulatory documents will be reviewed, 
including but not limited to: IRB/IEC composition and correspondence, laboratory 
certification(s), delegation of authority, and Investigator and study personnel curricula vitae. 
13.2. Sponsor’s Responsibility 
CSPC Pharma or its designee is responsible for the following: 
1. 
Selecting qualified Investigators 
2. 
Providing Investigators with the information they need to properly conduct an investigation 
3. 
Ensuring proper monitoring of the investigation 
4. 
Ensuring that the applicable regulatory authorities, and all participating Investigators are 
properly informed of significant new information regarding AEs or risks associated with the 
medication being studied 
As the sponsor, CSPC Pharma has delegated some responsibilities to a Contract Research 
Organization (CRO). 
13.3. Audits and Inspections 
CSPC Pharma’s Quality Assurance Unit (or representative) may conduct audits at the study 
site(s). Audits will include, but are not limited to: drug supply, presence of required documents, 
the informed consent process, laboratory specimen processing, and comparison of CRFs with 
source documents. The Investigator agrees to cooperate with audits conducted at a reasonable 
time and in a reasonable manner. 
Regulatory authorities worldwide may also audit the Investigator during or after the study. The 
Investigator should contact CSPC Pharma immediately if this occurs, and must fully cooperate 
with the audits conducted at a reasonable time in a reasonable manner. 
The Investigator is required to make all study documentation promptly available for inspection, 
review or audit at the study site upon request by sponsor, its representatives, or any appropriate 
regulatory agencies. 
 

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14. 
QUALITY CONTROL AND QUALITY ASSURANCE 
A quality control and quality assurance plan, addressing aspects of the trial that may affect data 
integrity or the protection of human subjects, may be instituted for this study. All audit findings 
will be summarized and placed on file with appropriate documentation of response/resolution. 
 
15. 
ETHICS 
The procedures set out in this study protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the sponsor and the Investigator abide by 
Good Clinical Practice (GCP), including but not limited to Title 21 Code of Federal Regulations 
(CFR) Parts 50, 56, and 312 and the International Conference on Harmonisation (ICH) 
guidelines and directives. Compliance with these regulations also constitutes compliance with 
the ethical principles described in the current revision of the Declaration of Helsinki, Tokyo 
2004 and applicable local regulatory requirements and law. 
Copies of these materials are available from CSPC Pharma and the CRO designee by request. 
The purpose of these regulations, legal obligations and guidance is to define the standards and 
principles for the proper conduct of clinical trials that have been developed by the medical, 
scientific, and regulatory communities. They are not intended to impede or restrict clinical 
research. 
The ethical standards defined within GCP are intended to ensure that: 
1. 
Human subjects are provided with an adequate understanding of the possible risks of their 
participation in the study, and that they have a free choice to participate or not. 
2. 
The study is conducted with diligence and in conformance with the protocol in such a way 
as to protect subject safety and ensure the integrity of the findings. 
3. 
The potential benefits of the research justify the risks. 
The Investigator is responsible for protecting the rights, safety, and welfare of subjects under 
his/her care, and for the control of the medications under investigation. 
The Principal Investigator will ensure that all persons assisting with the study are adequately 
informed about the protocol, any amendments to the protocol, the study drug, and their study 
related duties and functions. The Investigator will maintain a list of sub-Investigators and other 
appropriately qualified persons to whom he or she has delegated significant study-related duties. 
Individuals ineligible to conduct or work on clinical studies, including those ineligible as a result 
of debarment under the Generic Drug Enforcement Act of 1992, will not be allowed to conductor 
work on studies sponsored by CSPC Pharma. The Investigator is required to immediately 
disclose to CSPC Pharma in writing, if any person involved in the conduct of the study is 
debarred pursuant to a hearing by US FDA under this anti-fraud law, or if any proceeding for 
debarment is pending, or is (to the best of the Investigator’s knowledge) threatened. 

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The rest of this section of the protocol describes in more detail the specific GCP-defined 
responsibilities the Investigator assumes by agreeing to participate in this study. 
15.1. Ethics Review 
The Investigator (or designee) must submit this study protocol, the CSPC Pharma approved ICF, 
patient information sheets (PISs), subject recruitment materials, and other appropriated 
documents to the appropriate IRB or IEC, and following review of the submitted materials is 
required to forward to CSPC Pharma (or designee) a copy of the written and dated 
approval/favorable opinion signed by the Chairman, along with a list of the IRB/IEC 
composition. 
The approval/favorable opinion should clearly state the trial (study number, protocol title, and 
version number), the documents reviewed (Protocol, ICF, IB, etc) and the date of the review. The 
study will not commence at the study site until CSPC Pharma has received a copy of this written 
and dated approval/favorable opinion. 
During the trial, any amendment to the protocol and the ICF (as appropriate) should be submitted 
to the IRB/IEC. The IRB/IEC should also be informed of any event likely to affect the safety of 
subjects or the continued conduct of the trial, in particular any change in safety. Additionally, all 
updates to the IB will be sent to the IRB/IEC. A progress report will be sent to the IRB/IEC and 
the protocol will be reviewed annually (e.g., re-approved) or more frequently, as required by 
IRB/IEC or local regulations. 
The Investigator will notify the IRB/IEC of the conclusion of the clinical study within 1 month 
of completion or termination of the study. The final report sent to the IRB/IEC will also be sent 
to CSPC Pharma, along with the completed CRFs and all necessary regulatory documents, 
thereby fulfilling the Investigator’s regulatory responsibility. 
The Investigator will maintain a copy of all correspondence with the IRB/IEC, including copies 
of approved documents. The Investigator will also maintain a copy of the IRB/IEC membership 
list, including members’ occupation and qualifications (or a statement confirming compliance 
with GCP requirements for committee composition). An IRB or IEC General Assurance Number 
may be accepted in lieu of a membership roster. 
15.2. Ethical Conduct of the Study 
This study will be conducted in accordance with GCP as delineated by Title 21 CFR Parts 50,56, 
and 312, and the ICH guidelines and directives. Participating Investigators, including members 
of the Committees and National Coordinators, will receive compensation for their time but will 
receive no financial profit from their activities related to the trial. 
Before the first subject is enrolled in the study, all ethical, regulatory, and legal requirements 
must be met. 

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An Investigator participating in this study is required to maintain complete and accurate study 
documentation in compliance with current GCP standards and all applicable local regulations 
related to the conduct of a clinical study. 
15.3. Written Informed Consent 
Prior to performing any study-related activities under this protocol, including screening tests and 
assessments, written informed consent with the approved ICF must be obtained from the subject 
or subject’s legally authorized representative, as applicable, in accordance with local practice and 
regulations. Written informed consent must be obtained from all subjects participating in a 
clinical study conducted by CSPC Pharma. 
The background of the proposed study, the procedures, the benefits and risks of the study, and 
that study participation is voluntary for the subject must be explained to the subject. The subject 
must be given sufficient time to consider whether to participate in the study. 
A copy of the ICF, signed and dated by the subject, must be given to the subject. Confirmation of 
a subject’s informed consent must also be documented in the subject’s source documentation 
prior to any testing under this protocol, including screening tests and assessments. 
Each consent form should contain an authorization allowing the Principal Investigator(s) and 
CSPC Pharma to use and disclose patient health information (PHI) in compliance with local law. 
The original signed consent form will be retained with the study records. 
 
16. 
DATA HANDLING AND RECORD KEEPING 
16.1. Data Collection 
All data obtained for analysis in the clinical study described in this protocol will be documented 
in the CRF. Data reported in the CRFs should be consistent with and substantiated by the 
subject’s medical record and original source documents. Any discrepancies must be explained. 
Unless explicitly allowed in the CRF instructions, blank data fields are not acceptable. If a field 
is blank because the item was not done, the field will be marked “Not Done”. If the item is 
unknown, the field will be marked “Unknown”. 
Prior to the start of the study, the Principal Investigator will complete a Delegation of Authority 
form (Site Signature and Delegation Log), showing the signatures and handwritten initials of all 
individuals and the delegation of responsibilities, such as identifying those individuals who are 
authorized to make or change entries on CRFs. 
16.2. Case Report Form Completion 
Data within the CRF will be monitored by the Clinical Research Associate according to the 
Monitoring Plan. Queries will be generated based on discrepancies found while monitoring. Site 
personnel will review and respond to these queries appropriately. Additionally, the CRO and 

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CSPC Pharma may periodically perform aggregate data reviews, which could result in queries 
being generated for site personnel resolution. The final, completed CRF for each subject must be 
signed and dated by the Principal Investigator to signify that the Principal Investigator has 
reviewed the CRF and certifies it to be complete and accurate. 
16.3. Database Management, Data Clarification, and Quality Assurance 
A designated CRO will be responsible for data management. Data Management will develop a 
Data Management Plan (DMP) document and provide it to CSPC Pharma for approval. The 
DMP document will define all activities in the data collection and cleaning process. The detailed 
DMP will be based on the protocol, work scope, contract, analysis plans, data-flows, CRFs, data 
cleaning procedures, other supporting documents, and data management standards and practices. 
The programmed data validations will be run to check for database completeness and 
consistency, and queries will be generated upon data entry or via review by a Clinical Data 
Manager after entry. The site will respond to the data queries in a timely manner. 
Concurrent medications entered into the database will be coded using a WHO Anatomical 
Therapeutic Chemical dictionary. Coexistent diseases and AEs will be coded using MedDRA. 
Quality control procedures will be conducted prior to database lock according to the designated 
CRO SOPs. 
When the database has been declared to be complete and accurate, it will be locked. Any changes 
to the database after that time will only be made by joint written agreement between CSPC 
Pharma, the Trial Statistician, the Data Manager, and the Quality Assurance Auditor according to 
designated CRO SOPs. 
16.4. Inspection of Records/Source Documents 
According to the ICH guidelines for GCP, the sponsor or designee must verify data entered in 
the CRF against the source documents, except for the pre-identified source data directly 
documented in the CRF (if applicable). The ICF will include a statement by which the subject 
allows the sponsor’s duly authorized personnel, the IRB/IEC, and the regulatory authorities to 
have direct access to source data that supports the data in the CRF (e.g., subject’s medical file, 
appointment books, and original laboratory records). These personnel, bound by professional 
secrecy, must keep confidential all personal medical information. 
The objective of source document verification (SDV) is to comply with GCP and international 
regulatory requirements and to reduce the risks of fraud. Source document verification means 
ensuring that the source documents are an accurate and verifiable reflection of the subject’s 
participation in the study and that all relevant information that is recorded in the source 
document is accurately entered into the CRF. 
Where source documents serve as the basis for deriving data for the trial, SDV should ensure that 
these documents are correctly labeled and filed and that the data derived from them are correct. 

CSPC Ouyi Pharmaceutical Co. Ltd                                       
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All source documents pertaining to this study will be maintained by the Investigator and made 
available for inspection by authorized persons. If electronic progress notes and other electronic 
source documents are not Title 21 CFR Part 11 compliant, they are not considered a valid source 
for this study. If electronic records are printed, they should been marked as certified, all progress 
notes must be dated and signed by the Principal Investigator or sub-Investigator at the time of the 
visit. CSPC Pharma reserves the right to terminate the study for refusal of the Investigator to 
supply original source documentation for this clinical study. 
The Investigator will note in a source independent from the CRF the following information: 
1. 
Information to confirm that the subject exists (e.g., initials, date of birth, sex) 
2. 
Confirmation that the subject satisfies the inclusion/exclusion criteria 
3. 
Confirmation that the subject is taking part in the clinical trial 
4. 
Confirmation of the informed consent process 
5. 
Visit dates and documentation of protocol assessments and procedures 
6. 
Information concerning all AEs 
7. 
Details of concomitant and investigational medications 
Source document verification is not a substitute for clinical trial monitoring, the purpose of 
which is to ensure that the protocol has been followed correctly, the CRF has been fully and 
accurately completed, SDV has been carried out, and the study timelines and enrollment goals 
and requirements have been met. 
16.5. Retention of Records 
The Investigator must maintain all study documentation as confidential, and take measures to 
prevent accidental or premature destruction of these documents. 
The Investigator must retain the study documents at least 2 years after the last approval of a 
marketing application/new drug application for the indication investigated or at least 2 years 
have elapsed since the formal discontinuation of clinical development of the investigational 
product (e.g., the Investigational New Drug application is withdrawn). These documents should 
be retained for a longer period, however, if required by the applicable regulatory requirements or 
by an agreement with CSPC Pharma. 
The Investigator must notify CSPC Pharma prior to destroying any study essential documents. 
If the Investigator can no longer ensure archiving, he/she shall inform CSPC Pharma. The 
relevant records shall be transferred to a mutually agreed upon designee. 
 
17. 
CONFIDENTIALITY 
All information disclosed or provided by CSPC Pharma (or designee) or produced during the 
trial including, but not limited to, the protocol, the CRFs, the IB, and the results obtained during 
the course of the trial (if applicable), are confidential. The Investigator or any person under 

CSPC Ouyi Pharmaceutical Co. Ltd                                       
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his/her authority agrees to undertake to keep confidential and not to disclose the information to 
any third party without the prior written approval of CSPC Pharma. 
However, submission of this protocol and any other necessary documentation to the IRB/IEC is 
expressly permitted, the IRB/IEC members having the same obligation of confidentiality. 
All information generated in this study must be considered highly confidential and must not be 
disclosed to any persons not directly concerned with the study without written prior permission 
from CSPC Pharma. However, authorized regulatory officials and sponsor personnel (or 
designee) will be allowed full access to inspect and copy the records. The copied and inspected 
records will remain at the site and will not be transmitted or removed from the site. 
All study drugs, subject bodily fluids, and/or other materials collected shall be used solely in 
accordance with this protocol, unless otherwise agreed to in writing by CSPC Pharma and 
responsible ethics committee(s) or regulatory authorities. 
Subjects will be identified only by unique subject numbers in CRFs. Their full names may, 
however, be made known to a regulatory agency or other authorized officials in the event of 
inspections. Documents containing the full name or other personally identifiable information of 
the subject are to remain at the site. This information will not be transferred to CSPC Pharma nor 
be contained in regulatory filings. In the event of inspections by authorized agencies, this subject 
identification may be disclosed. 
17.1. Subject Data Protection 
Prior to any testing under this protocol, including screening tests and assessments, candidates 
must also provide all authorizations required by local law (e.g., PHI authorization in North 
America). 
The subject will not be identified by name in the CRF or in any study reports and these reports 
will be used for research purposes only. CSPC Pharma, its partner(s) and designee(s), and 
various government health agencies may inspect the records of this study. Every effort will be 
made to keep the subject’s personal medical data confidential. 
CSPC Pharma will protect individual subject information to the fullest extent possible during this 
trial. At no time will a subject become identified in any publication or presentation. 
However, the subject may have to become identified in the event of a regulatory authority 
auditor inspection in order to verify the accuracy of the data. Access to subject information is at 
the discretion of CSPC Pharma and cannot occur prior to database lock or other specified events 
as determined solely by the discretion of CSPC Pharma. 
 

CSPC Ouyi Pharmaceutical Co. Ltd                                       
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18. 
STUDY PROTOCOL AMENDMENTS 
The Investigator will not make any changes to this protocol without prior written consent from 
CSPC Pharma and subsequent approval by the IRB/IEC. Any permanent change to the protocol, 
whether it is an overall change or a change for specific study center(s), must be handled as a 
protocol amendment. Any amendment to the protocol that appears necessary as the study 
progresses will be fully discussed by the Investigator(s) and CSPC Pharma. If agreement is 
reached regarding the need for an amendment, it will be written by CSPC Pharma. The written 
amendment must be submitted to the chairman of the IRB/IEC identified with this responsibility. 
Except for administrative amendments, Investigators must await IRB/IEC approval of protocol 
amendments before implementing the change(s). 
Administrative amendments are defined as having no effect on the safety of the research 
subjects, scope of the investigation, or quality of the trial. However, a protocol change intended 
to eliminate an apparent immediate hazard to subjects should be implemented immediately, and 
the IRB/IEC notified within 5 days. CSPC Pharma will ensure submission of any protocol 
amendments to the appropriate regulatory agencies. 
When, in the judgment of the chairman of the local IRB/IEC, the Investigators, and/or CSPC 
Pharma, the amendment to the protocol substantially alters the study design and/or increases the 
potential risk to the subject, the currently approved written ICF will require similar modification. 
In such cases, the Investigator will obtain repeat informed consent from subjects enrolled in the 
study before expecting continued participation. 
 
19. 
PUBLICATION 
All information concerning the product as well as any information such as clinical indications for 
the study drugs, their formula, their formulation, methods of manufacture and other scientific 
data relating to it, that have been provided by CSPC Pharma or designee, and are unpublished, 
are confidential and must remain the sole property of CSPC Pharma. 
The Investigator will agree to use the information only for the purposes of carrying out this study 
and for no other purpose unless prior written permission from CSPC Pharma is obtained. CSPC 
Pharma has full ownership of the CRFs completed as part of the study. 
By signing the study protocol, the Investigator agrees that the results of the study may be used 
for the purposes of national and international registration, publication, and information for 
medical and pharmaceutical professionals by CSPC Pharma. If necessary, the authorities will be 
notified of the Investigator’s name, address, qualifications, and extent of involvement. 
CSPC Pharma or designee will prepare a final report on the study. The Investigator may not 
publish or present any information on this study without first presenting the information to CSPC 
Pharma for review. 

CSPC Ouyi Pharmaceutical Co. Ltd                                       
      Protocol #: LAM-US-101 
 
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APPENDIX A. 
LABORATORY ASSESSMENTS 
Hematology 
Clinical Chemistry 
Urinalysis 
Hemoglobin (Hgb) 
Hematocrit (Hct) 
Platelet count 
Red blood cell (RBC) count 
White blood cell (WBC) count 
with differential 
 
 
 
 
 
Alcohol test 
 
Blood urea nitrogen (BUN) 
Creatinine 
Total bilirubin 
Alkaline phosphatase 
Aspartate transaminase (AST) 
Alanine transaminase (ALT) 
Gamma-glutamyl 
transferase (GGT) 
Lactic dehydrogenase (LDH) 
Glucose 
Albumin 
Total protein 
Bicarbonate 
Phosphate 
Sodium 
Potassium 
Chloride 
Calcium 
Total cholesterol 
Urate 
pH 
Specific gravity 
Protein 
Glucose 
Ketones 
Bilirubin 
Blood 
Nitrites 
Leukocytes 
Urobilinogen 
Microscopic urine analysis  
Urine Drug Screen 
Serology Screen 
Amphetamines 
Barbiturates 
Cannabinoids 
Cocaine metabolites 
Opiates 
Benzodiazepines 
Methamphetamine 
 
 
Human immunodeficiency 
virus (HIV) 
Hepatitis B surface 
antigen (HBsAg) 
Hepatitis C virus (HCV) 
 
Other 
Pregnancy test