90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01247285
First received: November 22, 2010
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Fluoxetine Hydrochloride
Drug: PROZAC WEEKLY®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  • AUC0-inf of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).


Secondary Outcome Measures:
  • Cmax of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Informational comparison of Cmax values for the metabolite Norfluoxetine.

  • AUC0-t of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-t values for the metabolite Norfluoxetine.

  • AUC0-inf of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.


Enrollment: 26
Study Start Date: May 2001
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
90 mg Fluoxetine Hydrochloride Capsules (Teva)
Drug: Fluoxetine Hydrochloride
90 mg Capsules
Active Comparator: Reference Listed Drug
90 mg PROZAC WEEKLY® Capsules (Eli Lilly)
Drug: PROZAC WEEKLY®
90 mg Capsules
Other Name: Fluoxetine Hydrochloride (generic name)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years or age or older at the time of dosing. The weight range will not exceed + 15% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan Height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
  • Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
  • If female and:

    • Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), or
    • Is postmenopausal for at least 1 year, or
    • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  • Volunteers with a recent history of drug or alcohol addiction or abuse.
  • Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurological system(s) or psychiatric disease (as determined by the clinical investigators).
  • Volunteers whose clinical laboratory test values are outside the acceptable reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
  • Volunteers demonstrating a positive drug abuse screen when screened for this study.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breastfeeding.
  • Volunteers with a history of allergic response(s) to fluoxetine or related drugs.
  • Volunteers with a history of clinically significant allergies including drug allergies.
  • Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Volunteers who currently use tobacco products.
  • Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
  • Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
  • Volunteers who have donated plasma within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
  • Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
  • Volunteers who report taking any systemic prescription medications in the 14 days prior to Period I dosing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247285

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01247285     History of Changes
Other Study ID Numbers: R01-141
Study First Received: November 22, 2010
Results First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
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 April 14, 2014