To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00947076
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.


Condition Intervention Phase
Depression
Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
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: A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2001
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
Active Comparator: 2
Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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: NCT00947076

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00947076     History of Changes
Other Study ID Numbers: 005-49-11634
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antidepressant

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014