Pharmacodynamic Drug Interaction Between Cilostazol and Statins

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Simvastatin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C -> C + S<br>cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Simvastatin<br>* simvastatin qd for 7 days<br>* Other names: simvastatin (S); Zocor 40 mg;|
| Experimental: C + S -> C<br>cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Simvastatin<br>* simvastatin qd for 7 days<br>* Other names: simvastatin (S); Zocor 40 mg;|
| Experimental: S -> S + C<br>simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Simvastatin<br>* simvastatin qd for 7 days<br>* Other names: simvastatin (S); Zocor 40 mg;|
| Experimental: C + S -> S<br>cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Simvastatin<br>* simvastatin qd for 7 days<br>* Other names: simvastatin (S); Zocor 40 mg;|
| Experimental: R -> C + R<br>rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Rosuvastatin<br>* rosuvastatin qd for 7 days<br>* Other names: Rosuvastatin (R); Crestor 20 mg;|
| Experimental: C + R -> R<br>cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2 | Drug: Cilostazol<br>* cilostazol bid for 7 days<br>* Other names: cilostazol (C); Plettal 100 mg;Drug: Rosuvastatin<br>* rosuvastatin qd for 7 days<br>* Other names: Rosuvastatin (R); Crestor 20 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid lowering effect | lipid panel | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-platelet effect | platelet aggregation test | 7 days |