Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Completed · Phase 1

Conditions studied: To Determine the Bioequivalence Under Fasting Conditions

In brief

-To compare the single dose bioavailability of Kali and BTG

Key facts

Study ID

NCT00652886

Run by

Par Pharmaceutical, Inc.

People needed

26

Starts

2005-03-01

Expected to finish

2005-06-01

Last updated by the study team

2008-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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• Female subjects with positive or inconclusive results will be withdrawn from the study.

Where it is running

• Gateway Medical Research, Inc — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.