Overview

Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.

Phase:

Phase 1

Details

Lead Sponsor:

Torrent Pharmaceuticals Limited

Treatments:

Metformin