At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
Zolpidem Tartrate Tablets 10 mg +1 moredrug
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.
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
In Brief
A Phase 1 clinical trial evaluating Zolpidem Tartrate Tablets 10 mg and 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg for Healthy. Completed, enrolled 50 participants across 1 site.
Detailed Summary
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesIndia
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
Primary CompletionMay 2007
First PostedJul 2009
TodayJul 2026
First PostedJul 15, 2009
Enrollment StartFeb 24, 2007
Primary CompletionMay 2, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
Zolpidem Tartrate Tablets 10 mgdrug
'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mgdrug