Status:
COMPLETED
Pharmacodynamic Drug Interaction Between Cilostazol and Statins
Lead Sponsor:
Samsung Medical Center
Conditions:
Healthy
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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 su...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01870466
Start Date
June 1 2012
End Date
December 1 2013
Last Update
May 27 2015
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea