Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT01331447
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to exemestane or any comparable or similar product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 21 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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Trial Locations
- Locations (1)
BioKinetic Clinical Applications, Inc.
🇺🇸Springfield, Missouri, United States
BioKinetic Clinical Applications, Inc.🇺🇸Springfield, Missouri, United States