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Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Sponsor
Par Pharmaceutical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00652886
Collaborator
Cetero Research, San Antonio (Other)
26
Enrollment
1
Location
2
Arms
3
Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

-To compare the single dose bioavailability of Kali and BTG

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official 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.
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Jun 1, 2005

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate and Extend of Absorption [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gateway Medical Research, Inc St.Charles Missouri United States 63301

    Sponsors and Collaborators

    • Par Pharmaceutical, Inc.
    • Cetero Research, San Antonio

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00652886
    Other Study ID Numbers:
    • B053205
    First Posted:
    Apr 4, 2008
    Last Update Posted:
    Apr 4, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Bioequivalence, Oxandrolone,fasting
    Additional relevant MeSH terms:
    Disease
    Oxandrolone

    Study Results

    No Results Posted as of Apr 4, 2008