To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Phase 1
Completed
- Conditions
- Depression
- Interventions
- Registration Number
- NCT00913718
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 46
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista) Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista) 1 Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.) Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 86 days
- Secondary Outcome Measures
Name Time Method