NCT00835172

Glimepiride 4 mg Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of Glimepiride 4 mg Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking subjects under non-fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glimepiride 4 mg Tablets	1 x 4 mg, single-dose non-fasting
DRUG	AMARYL® 4 mg Tablets	1 x 4 mg, single-dose non-fasting

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States