To Determine the Bioequivalence Under Fasting Conditions Clinical Trial
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.
| Verified date | April 2008 |
| Source | Par Pharmaceutical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
-To compare the single dose bioavailability of Kali and BTG
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | June 2005 |
| Est. primary completion date | March 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 - Female subjects with positive or inconclusive results will be withdrawn from the study. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Gateway Medical Research, Inc | St.Charles | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Par Pharmaceutical, Inc. | Cetero Research, San Antonio |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate and Extend of Absorption | 24 hours | No |