DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fluoxetine Hydrochloride (Drug); PROZAC WEEKLY® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
James D Carlson, Pharm.D., Principal Investigator, Affiliation: PRACS Institute, Ltd.

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.

Clinical Details

Official title: A Relative Bioavailability Study of 90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax of Fluoxetine.

AUC0-t of Fluoxetine.

AUC0-inf of Fluoxetine.

Secondary outcome:

Cmax of Norfluoxetine.

AUC0-t of Norfluoxetine.

AUC0-inf of Norfluoxetine.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

PRACS Institute, Ltd., Fargo, North Dakota 58102, United States
Additional Information

Starting date: May 2001
Last updated: January 24, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017