Pharmacodynamic Drug Interaction Between Cilostazol and Statins

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer

The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

Inclusion Criteria:

• Healthy male subjects aged 20 - 55 years
• A body mass index in the range 18.5 - 27 kg/m2
• Willingness to participate during the entire study period
• Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

• Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
• Active bleeding or bleeding tendency
• History of gastrointestinal disease or surgery possibly affecting drug absorption
• History of clinically significant drug hypersensitivity
• Use of medication within 7 days before the first dose
• Heavy drinker (>140 g/week)
• Whole blood donation during 60 days before the study
• Judged not eligible for study participation by investigator