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

Verified by: Sandoz, June 2009
First Received: June 2, 2009 | Last Updated: June 3, 2009 | Phase: Phase 1 | Start Date: June 1996
Overall Status: Completed | Estimated Enrollment: 46
  • …
  • Tell a FriendPrint

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

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”

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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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

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/NCT00913718

Study ID Number: 960380

ClinicalTrials.gov Identifier: NCT00913718

Health Authority: United States: Institutional Review Board

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00913718