Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

Roxane Laboratories

Status

Completed

Conditions

Intermittent Claudication

Treatments

Drug: Cilostazol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00602407

CILO-05

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.