The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol
Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions
using a single-dose, randomized, 2-treatment, 2-period, crossover design.
- 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 Cilostazol or any comparable or similar