Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
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.
1 other identifier
interventional
26
1 country
1
Brief Summary
-To compare the single dose bioavailability of Kali and BTG
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2005
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedApril 4, 2008
April 1, 2008
Same day
April 1, 2008
April 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate and Extend of Absorption
24 hours
Study Arms (2)
A
EXPERIMENTALSubjects received Kali's products under fasting conditions
B
ACTIVE COMPARATORSubjects received BTG products under fasting conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Par Pharmaceutical, Inc.lead
- Cetero Research, San Antoniocollaborator
Study Sites (1)
Gateway Medical Research, Inc
Saint Charles, Missouri, 63301, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Herrmann
Cetero Research, San Antonio
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
March 1, 2005
Primary Completion
March 1, 2005
Study Completion
June 1, 2005
Last Updated
April 4, 2008
Record last verified: 2008-04