NCT00650169

Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg

Single-Dose Food In Vivo Bioequivalence Study of Clopidogrel Bisulfate Tablets (75 mg; Mylan) to Plavix® Tablets (75 mg; Bristol-Myers Squibb/Sanofi) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (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 clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clopidogrel Bisulfate Tablets 75 mg	75mg, single dose fed
DRUG	Plavix® Tablets 75 mg	75mg, single dose fed

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States