Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

April 3, 2008 updated by: Par Pharmaceutical, Inc.

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.

-To compare the single dose bioavailability of Kali and BTG

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St.Charles, Missouri, United States, 63301
        • Gateway Medical Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Subjects received Kali's products under fasting conditions
Drug: Oxandrolone
Tablets, 10mg, single-dose
Other Names:
  • Oxandrin
Active Comparator: B
Subjects received BTG products under fasting conditions
Drug: Oxandrin
tablets, 10mg, single-dose
Other Names:
  • Oxandrolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate and Extend of Absorption
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Par Pharmaceutical, Inc.

Collaborators

Cetero Research, San Antonio

Investigators

  • Principal Investigator: Steve Herrmann, Cetero Research, San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B053205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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