90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

NCT ID: NCT01247285

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2001-07-31

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 non-fasting conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Investigational Test Product

90 mg Fluoxetine Hydrochloride Capsules (Teva)

Group Type: EXPERIMENTAL

Fluoxetine Hydrochloride

Intervention Type: DRUG

90 mg Capsules

Reference Listed Drug

90 mg PROZAC WEEKLY® Capsules (Eli Lilly)

Group Type: ACTIVE_COMPARATOR

PROZAC WEEKLY®

Intervention Type: DRUG

90 mg Capsules

Interventions

Fluoxetine Hydrochloride

90 mg Capsules

Intervention Type: DRUG

PROZAC WEEKLY®

90 mg Capsules

Intervention Type: DRUG

Other Intervention Names

Fluoxetine Hydrochloride (generic name)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

James D Carlson, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute, Ltd.

Locations

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

R01-141

Identifier Type: -

Identifier Source: org_study_id