Status:
COMPLETED
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborating Sponsors:
Cetero Research, San Antonio
Conditions:
To Determine the Bioequivalence Under Fasting Conditions
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
-To compare the single dose bioavailability of Kali and BTG
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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- Female subjects with positive or inconclusive results will be withdrawn from the study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00652886
Start Date
March 1 2005
End Date
June 1 2005
Last Update
April 4 2008
Active Locations (1)
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1
Gateway Medical Research, Inc
Saint Charles, Missouri, United States, 63301