drugset / Trial / NCT00650234

Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg

NCT00650234 ↗

Phase 1 Completed 47 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.

Timeline

Start
2004-02
Primary completion
2004-03
Completion
2004-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg Oral

Indications

No indication recorded.