NCT00649454

Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Glipizide and Metformin HCl Tablets (5 mg/500 mg; Mylan) to Metaglip® Tablets (5 mg/500 mg; Bristol-Myers Squibb) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glipizide and Metformin HCl Tablets 5 mg/500 mg	5/500mg, single dose fasting
DRUG	Metaglip® Tablets 5 mg/500 mg	5/500mg, single dose fasting

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States