Pharmacodynamic Drug Interaction Between Cilostazol and Statins

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cilostazol; Rosuvastatin Calcium; Simvastatin

Criteria

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