90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

NCT01247272 | Completed Phase 1 Results

• 1 other identifier: R01-140
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Cmax of Norfluoxetine.

  Blood samples collected over a 25 day period.

• AUC0-t of Norfluoxetine.

  Blood samples collected over a 25 day period.

• AUC0-inf of Norfluoxetine.

  Blood samples collected over a 25 day period.

Study Arms (2)

Reference Listed Drug

ACTIVE COMPARATOR

90 mg PROZAC WEEKLY® Capsules (Eli Lilly)

Drug: PROZAC WEEKLY®

Investigational Test Product

EXPERIMENTAL

90 mg Fluoxetine Hydrochloride Capsules (Teva)

Drug: Fluoxetine Hydrochloride

Interventions

Fluoxetine Hydrochloride DRUG

90 mg Capsules

Investigational Test Product

PROZAC WEEKLY® DRUG

90 mg Capsules

Also known as: Fluoxetine Hydrochloride (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

Fluoxetine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: Teva Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm.D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: May 1, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: February 21, 2011
• Results First Posted: February 21, 2011

Record last verified: 2011-01

Locations

US (1)