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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

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ClinicalTrials.gov Identifier: NCT00913588
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : May 1996
Actual Primary Completion Date : August 1996
Actual Study Completion Date : August 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
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)



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


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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.

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)

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 Posted: June 4, 2009    Key Record Dates
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