Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions
Not Applicable
Completed
- Conditions
- Short Term Treatment of Insomnia
- Registration Number
- NCT00694187
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Two Period, Seven day washout
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Houston, Texas, United States
Novum Pharmaceutical Research Services🇺🇸Houston, Texas, United States