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Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

NCT00833937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-19

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Zolpidem 10 mg tablets

1 x 10 mg

DRUG

AMBIEN® 10 mg tablets

1 x 10 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Shirley Ann Kennedy, M.D. · Novum Pharmaceuticals Research Services

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2002-03-31
Completion
2002-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00833937 on ClinicalTrials.gov