A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions
N/A
18 Years
55 Years
18 Years
55 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
bioequivalence determined by statistical comparison Cmax
Outcome Time Frame:
21 days
Safety Issue:
No
Principal Investigator
Dennis N Morrison, D.O.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bio-Kinetic Clinical Applications, Inc.
Authority:
United States: Institutional Review Board
Study ID:
EXEM-02
NCT ID:
NCT01331434
Start Date:
October 2004
Completion Date:
October 2004
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Bio-Kinetic Clinical Applications, Inc. | Springfield, Missouri 65802 |
