Overview
Pharmacodynamic Drug Interaction Between Cilostazol and Statins
Status:
Completed
Completed
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Samsung Medical CenterTreatments:
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