Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions

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.

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 Cilostazol or any comparable or similar product.