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Clinical Trials/NCT00694317
NCT00694317CompletedNot Applicable

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.

Roxane Laboratories1 site in 1 country40 target enrollmentStarted: February 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
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' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) 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 Zaleplon or any comparable or similar product.

Outcomes

Primary Outcomes

Bioequivalence

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (1)

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