A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fasted Conditions
N/A
18 Years
45 Years
18 Years
45 Years
Not Enrolling
Male
Breast Cancer
Male
Breast Cancer
Trial Information
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fasted 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 letrozole 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:
31 days
Safety Issue:
No
Principal Investigator
Alan Copa, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
PRACS Institute, Ltd.
Authority:
United States: Institutional Review Board
Study ID:
LETR-T25-PVFS-1
NCT ID:
NCT01367652
Start Date:
March 2008
Completion Date:
April 2008
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| PRACS Institute, Ltd. | Fargo, North Dakota 58104 |
