Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine obtained from two formulations will be used to access the interchangeability of the products

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

Details

• Lead Sponsor: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
• Collaborator: Chinese University of Hong Kong
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• Body Mass Index between 18 to 27

• Accessible vein for blood sampling

• High probability for compliance and completion of the study

• No significant abnormalities in general physical examination

• Electrocardiogram (ECG) recording within normal limits

• Biochemical and haematological parameters within normal limits

• Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration

Exclusion Criteria:

• History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study

• Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry and haematological test

• Tobacco use in any forms

• Regular consumer of alcohol

• Blood donation within 4 weeks prior to the start of the study

• Use of amlodipine within 4 weeks before the study

• Use of antihypertensive medications within 4 weeks before the study

• Volunteer in any other clinical drug study within 2 months prior to this study

• Hypersensitivity to amlodipine or other drugs in its class

• History of drug abuse in any form

• Female subjects who are breastfeeding or pregnant