Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652886

Enrollment

Registered

2008-04-04

Start date

2005-03-31

Completion date

2005-06-30

Last updated

2008-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Determine the Bioequivalence Under Fasting Conditions

Keywords

Bioequivalence, Oxandrolone,fasting

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.

Interventions

DRUGOxandrolone

Tablets, 10mg, single-dose

DRUGOxandrin

tablets, 10mg, single-dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Rate and Extend of Absorption	24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026