CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Zolpidem 10 mg tablets +1 moredrug
Likely dose
Zolpidem 10 mg orally, single doseAI-extracted
Key inclusion· 2
  • ✓Non-smoker at least 18 years of age
  • ✓BMI of 30 or less
Key exclusion· 8
  • ✕Significant recent history of chronic alcohol consumption or drug addiction
  • ✕Serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma
  • ✕History of allergic responses to zolpidem or drug class
  • ✕Tobacco use in any form; three months abstinence required

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00833937
NCT00833937Phase 1Completed
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A Relative Bioavailability Study of Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 2, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Zolpidem 10 mg tablets and AMBIEN® 10 mg tablets for Healthy. Completed, enrolled 24 participants across 2 sites.

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 non-fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2, 2009
Enrollment StartMar 1, 2002
Primary CompletionMar 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