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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913588
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  Purpose
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.

Condition Intervention Phase
Depression 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) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 141 days ]

Enrollment: 24
Study Start Date: May 1996
Study Completion Date: August 1996
Primary Completion Date: August 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
Drug: Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
Experimental: 2
Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
Drug: Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
Active Comparator: 3
Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
Drug: Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913588


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: NCT00913588     History of Changes
Other Study ID Numbers: 960379
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

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