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Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00652886
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by:
Par Pharmaceutical, Inc.

Study Description
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Brief Summary:
-To compare the single dose bioavailability of Kali and BTG

Condition or disease Intervention/treatment Phase
To Determine the Bioequivalence Under Fasting Conditions Drug: Oxandrolone Drug: Oxandrin 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
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Study Type : Interventional  (Clinical Trial)
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 : March 2005
Actual Primary Completion Date : March 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Oxandrolone

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Subjects received Kali's products under fasting conditions
 Drug: Oxandrolone
Tablets, 10mg, single-dose
Other Name: Oxandrin
Active Comparator: B
Subjects received BTG products under fasting conditions
 Drug: Oxandrin
tablets, 10mg, single-dose
Other Name: Oxandrolone


Outcome Measures
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Primary Outcome Measures :
  1. Rate and Extend of Absorption [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652886


Locations
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United States, Missouri
Gateway Medical Research, Inc
St.Charles, Missouri, United States, 63301
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Cetero Research, San Antonio
Investigators
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Principal Investigator: Steve Herrmann Cetero Research, San Antonio
More Information
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Responsible Party: Dr. Alfred Elvin, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00652886    
Other Study ID Numbers: B053205
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008
Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, Oxandrolone,fasting
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Oxandrolone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents