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Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

NCT00658541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2011-05-03

Study results available
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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.

Conditions

  • Healthy
  • Therapeutic Equivalency

Interventions

DRUG

Zolpidem Tartrate 10 mg tablet

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

DRUG

Zolpidem Tartrate 10 mg tablet (Ambien®)

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

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-05-31
Completion
2004-05-31

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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 NCT00658541 on ClinicalTrials.gov