NCT00650234

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

Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR Tablets (500 mg; Bristol-Myers Squibb) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride ER Tablets 500 mg	500mg, single dose fasting
DRUG	Glucophage® XR Tablets 500 mg	500mg, single dose fasting

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States