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

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.
 
ClinicalTrials.gov Identifier: NCT00947076
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Tracking Information
First Submitted Date  ICMJE July 24, 2009
First Posted Date  ICMJE July 27, 2009
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE February 2001
Actual Primary Completion Date April 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
Bioequivalence based on AUC and Cmax [ Time Frame: 42 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Official Title  ICMJE A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg
Brief Summary To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
  • Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
Study Arms  ICMJE
  • Experimental: 1
    Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
    Intervention: Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
  • Active Comparator: 2
    Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
    Intervention: Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2001
Actual Primary Completion Date April 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947076
Other Study ID Numbers  ICMJE 005-49-11634
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories Inc.
PRS Account Sandoz
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP