Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Par Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

To Determine the Bioequivalence Under Fasting Conditions

Treatments

Drug: Oxandrin

Drug: Oxandrolone

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00652886

B053205

Details and patient eligibility

About

-To compare the single dose bioavailability of Kali and BTG

Full description

-To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
Each subject shall be given a general physical examination within 28days of the initiation study.
At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
Each female subject will be given a serum test as part of the pregnancy study screening process.
Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen

Exclusion criteria

Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
Female subjects who are not able to bear children will not be allowed to participate.
Female subjects with positive or inconclusive results will be withdrawn from the study.