Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
Not Applicable
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT01331434
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47
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.
What are the molecular mechanisms of exemestane in aromatase inhibition for breast cancer treatment?
How does exemestane compare to other aromatase inhibitors in postmenopausal breast cancer patients?
What are the key biomarkers for predicting exemestane response in hormone receptor-positive breast cancer?
What adverse events are associated with exemestane use under fed conditions and how are they managed?
Are there combination therapies involving exemestane that improve outcomes in ER+ breast cancer patients?
Trial Locations
- Locations (1)
Bio-Kinetic Clinical Applications, Inc.
🇺🇸Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, Inc.🇺🇸Springfield, Missouri, United States