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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