Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: To Determine the Bioequivalence Under Fasting Conditions
• Interventions: Drug: Oxandrin; Drug: Oxandrolone

• Registration Number: NCT00652886
• Lead Sponsor: Par Pharmaceutical, Inc.

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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-03
• Study Completion: 2005-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Last Update Submitted: 2008-04-03
• Study First Posted: 2008-04-04
• Last Update Posted: 2008-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Oxandrin	Subjects received BTG products under fasting conditions
A	Oxandrolone	Subjects received Kali's products under fasting conditions

Primary Outcome Measures

Name	Time	Method
Rate and Extend of Absorption	24 hours

Trial Locations

Locations (1)

Gateway Medical Research, Inc; 🇺🇸 St.Charles, Missouri, United States