Healthy
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGCilostazol
cilostazol bid for 7 days
DRUGSimvastatin
simvastatin qd for 7 days
DRUGRosuvastatin
rosuvastatin qd for 7 days
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lipid lowering effect | 7 days | lipid panel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-platelet effect | 7 days | platelet aggregation test |
Countries
South Korea
Outcome results
None listed