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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
To Determine the Bioequivalence Under Fasting Conditions | Drug: Oxandrolone Drug: Oxandrin | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Subjects received Kali's products under fasting conditions
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Drug: Oxandrolone
Tablets, 10mg, single-dose
Other Name: Oxandrin |
Active Comparator: B
Subjects received BTG products under fasting conditions
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Drug: Oxandrin
tablets, 10mg, single-dose
Other Name: Oxandrolone |
- Rate and Extend of Absorption [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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
United States, Missouri | |
Gateway Medical Research, Inc | |
St.Charles, Missouri, United States, 63301 |
Principal Investigator: | Steve Herrmann | Cetero Research, San Antonio |
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 |
Bioequivalence, Oxandrolone,fasting |
Disease Pathologic Processes Oxandrolone Androgens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anabolic Agents |