Skip to main content
OpenTrials
Completed

NCT Number: NCT00652886

Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

-To compare the single dose bioavailability of Kali and BTG

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gateway Medical Research, Inc

Saint Charles, Missouri, 63301, United States

About this study

-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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Female subjects with positive or inconclusive results will be withdrawn from the study.

Treatment and study plan

Oxandrolone

Drug

Tablets, 10mg, single-dose

Other names: Oxandrin

Oxandrin

Drug

tablets, 10mg, single-dose

Other names: Oxandrolone

Primary outcomes

  1. Rate and Extend of Absorption

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Par Pharmaceutical, Inc.

Industry

Collaborators

  • Cetero Research, San Antonio

Registry information

Official study title

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.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 4, 2008
Registry last updated
Apr 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.