At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Zolpidem Tartrate Tablets 10 mgdrug
Likely dose
Zolpidem Tartrate Tablets 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Zolpidem Tartrate Tablets 10 mg for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesIndia
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
Primary CompletionJun 2005
Study CompletionJul 2005
First PostedJul 2009
TodayJul 2026
First PostedJul 15, 2009
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2005
Study CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.0 years ago
Interventions
Zolpidem Tartrate Tablets 10 mgdrug