To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

Verified by: Sandoz, June 2009
First Received: June 2, 2009 | Last Updated: June 3, 2009 | Phase: Phase 1 | Start Date: May 1996
Overall Status: Completed | Estimated Enrollment: 24
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To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions...

Brief Summary

Official Title: “Comparative, Randomized, Single-Dose, 3-Way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fed and Fasted Conditions Following Administration of a 40 mg Dose”

To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: August 1996

Intervention(s) in this Clinical Trial

  • Drug: Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
  • Drug: Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
  • Drug: Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
  • Experimental: 2
    • Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
  • Active Comparator: 3
    • Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

Outcome Measures for this Clinical Trial

Primary Measures

  • Bioequivalence based on AUC and Cmax
    • Time Frame: 141 days
      Safety Issue?: No

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 Investigator Information

Lead Investigator: Sandoz Inc. Industry

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, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00913588

Study ID Number: 960379

ClinicalTrials.gov Identifier: NCT00913588

Health Authority: United States: Institutional Review Board

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