NCT00939367

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions

Randomized, Two Period Crossover Studies in Fed Healthy, Normal Subjects to Compare the Single Dose Bioavailability of Torrent's Zolpidem Tartrate Tablets 10 mg and Sanofi-Synthelabo's Ambien® 10 mg Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.

Detailed description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under Fed Condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolpidem Tartrate Tablets 10 mg
DRUG	'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg

Timeline

• Start date: 2007-02-24
• Primary completion: 2007-05-02
• Completion: 2007-05-02
• First posted: 2009-07-15
• Last updated: 2018-06-28
• Results posted: 2013-11-14

Locations

1 site across 1 country: India