Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

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.

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.

Key Inclusion Criteria:

1. 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.

2. Considered healthy by the Principal Investigator, based on a detailed medical history,
full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;

3. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6
months before screening;

4. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;

Exclusion Criteria:

1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
immunologic, lipid metabolism disorders, or drug hypersensitivity;

2. Mean systolic blood pressure of three measurements >140 mmHg, or a mean diastolic
blood pressure of three measurements >90 mmHg at screening.

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;

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.