Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Overview

The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Full Title of Study: “A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2004

Interventions

  • Drug: Zaleplon

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence
    • Time Frame: Baseline, Two Period, Seven day washout

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Roxane Laboratories
  • Provider of Information About this Clinical Study
    • Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc.
  • Overall Official(s)
    • So Ran Hong, M.D., Principal Investigator, Novum Pharmaceutical Research Services

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