Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

-To compare the single dose bioavailability of Kali and BTG

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Cetero Research, San Antonio
• Treatments: Oxandrolone

Criteria

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• Female subjects with positive or inconclusive results will be withdrawn from the study.