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Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

NCT ID: NCT00652886

Last Updated: 2008-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-06-30

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.

Conditions

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To Determine the Bioequivalence Under Fasting Conditions

Keywords

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Bioequivalence, Oxandrolone,fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Subjects received Kali's products under fasting conditions

Group Type EXPERIMENTAL

Oxandrolone

Intervention Type DRUG

Tablets, 10mg, single-dose

B

Subjects received BTG products under fasting conditions

Group Type ACTIVE_COMPARATOR

Oxandrin

Intervention Type DRUG

tablets, 10mg, single-dose

Interventions

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Oxandrolone

Tablets, 10mg, single-dose

Intervention Type DRUG

Oxandrin

tablets, 10mg, single-dose

Intervention Type DRUG

Other Intervention Names

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Oxandrin Oxandrolone

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cetero Research, San Antonio

NETWORK

Sponsor Role collaborator

Par Pharmaceutical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Par Pharmaceutical, Inc.

Principal Investigators

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Steve Herrmann

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Gateway Medical Research, Inc

Saint Charles, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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B053205

Identifier Type: -

Identifier Source: org_study_id