NCT00835497

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting

A Relative Bioavailability Study of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	5 mg/500 mg Glipizide Metformin Hydrochloride Tablets	1 x 5 mg/500 mg, single-dose fasting
DRUG	5 mg/500 mg METAGLIP™ Tablets	1 x 5 mg/500 mg, single-dose fasting

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2009-02-03
• Last updated: 2009-09-15
• Results posted: 2009-08-18

Locations

2 sites across 1 country: United States