Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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-To compare the single dose bioavailability of Kali and BTG

Detailed Description
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-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.

Official Title
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Compare the Relative Bioavailability of Oxandrolone 10mg Tablets With That of OXANDRIN 10 mg Tablets Following a Single Oral Dose(1*10 mg Tablet) in Healthy, Adult Subjects Under Fasting Conditions.

Conditions
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To Determine the Bioequivalence Under Fasting Conditions

Intervention / Treatment
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* Drug: Oxandrolone
* Drug: Oxandrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subjects received Kali's products under fasting conditions | Drug: Oxandrolone<br>* Tablets, 10mg, single-dose<br>* Other names: Oxandrin;|
| Active Comparator: B<br>Subjects received BTG products under fasting conditions | Drug: Oxandrin<br>* tablets, 10mg, single-dose<br>* Other names: Oxandrolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Extend of Absorption |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Oxandrolone,fasting