Overview

Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

Status:
Completed
Trial end date:
2017-10-15
Target enrollment:
Participant gender:
Summary
The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa 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:
Methyldopa