90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Fluoxetine Hydrochloride

Drug: PROZAC WEEKLY®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01247272

R01-140

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.