To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions...
Date First Received: June 2, 2009
Last Updated: June 3, 2009
Verified by: Sandoz Inc., June 2009
Clinical Trial Phase: Phase 1 | Start Date: June 1996
Overall Status: Completed
Estimated Enrollment: 46
Brief Summary
Official Title: “Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fasting Conditions Following Administration of a 40 mg Dose”
Condition Keyword(s):
To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Study Primary Completion Date: July 1996
Intervention(s) in this Clinical Trial
- Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
- Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
- Active Comparator: 2
- Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
Outcome Measures for this Clinical Trial
Primary Measures
- Bioequivalence based on AUC and Cmax
- Time Frame: 86 days
Safety Issue?: No
- Time Frame: 86 days
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Sandoz Inc.
Overall Clinical Trial Officials and Contacts
Roderick Malone, M.D. Principal Investigator Clinical Research Center (Cincinnati)
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00913718
Study ID Number: 960380
ClinicalTrials.gov Identifier: NCT00913718
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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