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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 Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913718
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose
To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.

Condition Intervention Phase
Depression
Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 86 days ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 1996
Study Completion Date: July 1996
Primary Completion Date: July 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
Active Comparator: 2
Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913718

Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Roderick Malone, M.D. Clinical Research Center (Cincinnati)
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913718     History of Changes
Other Study ID Numbers: 960380 
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016