NCT00648362

Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Glimepiride Tablets (1 mg; Mylan) to Amaryl® Tablets (1 mg; Aventis) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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 glimepiride 1 mg tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glimepiride Tablets 1 mg	1mg, single dose fasting
DRUG	Amaryl® Tablets 1 mg	1mg, single dose fasting

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2004-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States