90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

A Relative Bioavailability Study of 90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

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 fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PROZAC WEEKLY®; Drug: Fluoxetine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • PRACS Institute, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of 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 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 neurologic 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 medication in the 14 days prior to Period I dosing.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference Listed Drug; 90 mg PROZAC WEEKLY® Capsules (Eli Lilly)	Drug: PROZAC WEEKLY®; 90 mg Capsules; Other Names: Fluoxetine Hydrochloride (generic name)
Experimental: Investigational Test Product; 90 mg Fluoxetine Hydrochloride Capsules (Teva)	Drug: Fluoxetine Hydrochloride; 90 mg Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Fluoxetine.	Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).	Blood samples collected over a 25 day period.
AUC0-t of Fluoxetine.	Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).	Blood samples collected over a 25 day period.
AUC0-inf of Fluoxetine.	Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).	Blood samples collected over a 25 day period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Norfluoxetine.	Informational comparison of Cmax values for the metabolite Norfluoxetine.	Blood samples collected over a 25 day period.
AUC0-t of Norfluoxetine.	Informational comparison of AUC0-t values for the metabolite Norfluoxetine.	Blood samples collected over a 25 day period.
AUC0-inf of Norfluoxetine.	Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).	Blood samples collected over a 25 day period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): July 1, 2001
• Study Completion (Actual): July 1, 2001

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): February 21, 2011
• Last Update Submitted That Met QC Criteria: January 24, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: R01-140