NCT01630915

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fed Condition

An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Bioequivalence Study of Clopidogrel Tablets USP 75mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Plavix® (Clopidogrel Bisulfate Tablets) 75mg [Reference Formulation, Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA], in Healthy Human Volunteers Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: —

Summary

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a washout period of 7 days. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Clopidogrel Tablets USP 75 mg

Timeline

• First posted: 2012-06-28
• Last updated: 2012-06-28

Locations

1 site across 1 country: India