A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening
- 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
Type of Study:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
bioequivalence determined by statistical comparison Cmax
Outcome Time Frame:
Alan K Copa, PharmD
PRAC Institute, Ltd.
United States: Food and Drug Administration
- Breast Cancer
- Breast Neoplasms
|PRACS Institute, Ltd.||Fargo, North Dakota 58104|