NCT00939536

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

Studies in Fasted Healthy, Normal Subjects to Compare the Single Dose Bio-availability 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: 24 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

* Objective: * To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human subjects. * Study Design: * Open label, randomized, two-period, two-treatment, two-sequence single dose crossover design.

Detailed description

Open label, randomized, two-period, two-treatment, two-sequence single dose

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolpidem Tartrate Tablets 10 mg

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-07-01
• First posted: 2009-07-15
• Last updated: 2013-10-22
• Results posted: 2013-10-22

Locations

1 site across 1 country: India