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

• Status: Completed
• Trial end date: 2018-09-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Conjupro Biotherapeutics; Conjupro Biotherapeutics, Inc.
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Maleic acid; Niacin

Criteria

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.