Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers

• Status: Completed
• Trial end date: 2017-03-21
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days

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

Details

• Lead Sponsor: Shanghai Haini Pharmaceutical Co., Ltd.
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

1. Healthy adult volunteers of 18-40 years old, male or female.

2. Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.

3. No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.

4. Medically healthy subjects with clinically normal laboratory profiles and ECGs.

5. Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration

6. Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

1. History of allergy or hypersensitivity to amlodipine

2. Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study

3. History of postural hypotension

4. Blood donation or lost more than 400mL blood within 3 months prior to the study

5. Use of medications within 2 weeks before the study

6. Volunteer in any other clinical drug study within 3 months prior to this study

7. Drug abuse or alcohol abuse (220ml beer /day or >5 times in 2 hours)

8. Smoker (>10 cigarettes/day)

9. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test

10. Abnormal chest X-ray results with clinical significance

11. Women of childbearing potential, pregnant and lactating women.

12. Other unfavorable factors diagnosed by investigators.