To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg
Phase 1
Completed
- Conditions
- Anxiety
- Interventions
- Registration Number
- NCT00912145
- Lead Sponsor
- Sandoz
- Brief Summary
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
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Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.) Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.) 2 Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.) Alprazolam Tablets, 2 mg, Xanax (The Upjohn Company)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 13 days
- Secondary Outcome Measures
Name Time Method