At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 38 enrolled
Drug / intervention
Zolpidem 10 mg tablets +1 moredrug
Likely dose
Zolpidem 10 mg tabletsfrom 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.
A Relative BioAvailability Study of Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Zolpidem 10 mg tablets and AMBIEN® 10 mg tablets for Healthy. Completed, enrolled 38 participants across 1 site.
Detailed Summary
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2002
Primary CompletionFeb 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 2, 2009
Enrollment StartFeb 1, 2002
Primary CompletionFeb 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Zolpidem 10 mg tabletsdrug
1 x 10 mg
AMBIEN® 10 mg tabletsdrug
1 x 10 mg