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Clinical Trials/NCT00602719
NCT00602719CompletedNot Applicable

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions

Roxane Laboratories2 sites in 1 country30 target enrollmentStarted: March 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Bioequivalence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

  • •Positive test for HIV, Hepatitis B, or Hepatitis C.
  • •Treatment with known enzyme altering drugs.
  • •History of allergic or adverse response to Zolpidem or any comparable or similar product.

Outcomes

Primary Outcomes

Bioequivalence

Time Frame: Baseline, Two period, Seven day washout

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

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Bioequivalency Study of Zolpidem Tartrate... | Clinical Trial