NCT00836472

Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting

Randomized, 2-Way Crossover, Bioequivalence Study of Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets and Glucovance® 5 mg/500 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glyburide/Metformin 5 mg/500 mg Tablets	1 x 5 mg/500 mg, single-dose fasting
DRUG	Glucovance® 5 mg/500 mg Tablets	1 x 5 mg/500 mg, single-dose fasting

Timeline

• Start date: 2003-04-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2009-02-04
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada