CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT00658541
NCT00658541Phase 1Completed
CompareCT.gov

A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10mg, Compared to an Equivalent Dose of Ambien® in Fed, Healthy, Adult Subjects

Mutual Pharmaceutical Company, Inc.·interventional·Posted Apr 15, 2008·Updated May 3, 2011

In Brief

A Phase 1 clinical trial evaluating Zolpidem Tartrate 10 mg tablet and Zolpidem Tartrate 10 mg tablet (Ambien®) for Healthy and Therapeutic Equivalency. 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 Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Therapeutic Equivalency
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2008
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 18.2 years ago

Interventions

Zolpidem Tartrate 10 mg tabletdrug

10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Zolpidem Tartrate 10 mg tablet (Ambien®)drug

10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.