Overview

Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Collaborator:
Chinese University of Hong Kong
Treatments:
Amlodipine