At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 38 enrolled
Drug / intervention
Zolpidem Tartrate 10 mg tablet +1 moredrug
Likely dose
Zolpidem Tartrate 10 mg tabletfrom 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 Randomized, Two-way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10 mg, Compared to an Equivalent Dose of Ambien® in Healthy Adult Subjects.
In Brief
A Phase 1 clinical trial evaluating Zolpidem Tartrate 10 mg tablet and Zolpidem Tartrate 10 mg tablet (Ambien®) for Healthy. Completed, enrolled 38 participants.
Detailed Summary
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
Primary CompletionMay 2004
First PostedMay 2008
TodayJul 2026
First PostedMay 28, 2008
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 18.1 years ago
Interventions
Zolpidem Tartrate 10 mg tabletdrug
10 mg tablet administered after an overnight fast of at least 10 hours
Zolpidem Tartrate 10 mg tablet (Ambien®)drug
10 mg tablet administered after an overnight fast of at least 10 hours