Overview

BE Study of Metformin GSK 500mg

Status:
Completed
Trial end date:
2012-05-18
Target enrollment:
Participant gender:
Summary
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study. To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male subjects under fasting condition and to monitor the safety of the study subjects.
Phase:
Phase 2
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Metformin