Overview

90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

Status:
Completed
Trial end date:
2001-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Fluoxetine
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.