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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

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ClinicalTrials.gov Identifier: NCT00913718
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 1996
Actual Primary Completion Date : July 1996
Actual Study Completion Date : July 1996

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 86 days ]

Eligibility Criteria
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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
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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): NCT00913718


Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Roderick Malone, M.D. Clinical Research Center (Cincinnati)
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913718    
Other Study ID Numbers: 960380
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
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