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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C -> C + S | Experimental | cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2 |
|
| C + S -> C | Experimental | cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2 |
|
| S -> S + C | Experimental | simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2 |
|
| C + S -> S | Experimental | cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2 |
|
| R -> C + R | Experimental | rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2 |
|
| C + R -> R | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | cilostazol bid for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| lipid lowering effect | lipid panel | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| anti-platelet effect | platelet aggregation test | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Wook Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D019821 | Simvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2 |
|
|
| Simvastatin | Drug | simvastatin qd for 7 days |
|
|
| Rosuvastatin | Drug | rosuvastatin qd for 7 days |
|
|
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |