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This is a randomized, open-label, single & multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male volunteers
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).
On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin+Cilostazol | Experimental | Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8. |
|
| Pravastatin+Cilostazol | Active Comparator | Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 40 mg on Day 1 & Day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the time-concentration curve) of Simvastatin | up to 12 hours after Simvastatin dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum plasma concentration) of Simvastatin | up to 12 hours after Simvastatin dosing | |
| Cmax (maximum plasma concentration) of Pravastatin | up to 12 hours after Pravastatin dosing | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doo-Yeoun Cho, MD | Contact | +82-31-219-4271 | dooycho@ajou.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Doo-Yeoun Cho, MD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Medical Center | Recruiting | Suwon | Gyeonggi-do | 443-380 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050197 | Atherosclerosis |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D017035 | Pravastatin |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Pravastatin | Drug | Pravastatin 20 mg on Day 1 & Day 8. |
|
|
| Cilostazol | Drug | Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin. |
|
|
| AUC (area under the time-concentration curve) of Pravastatin |
| up to 12 hours after Pravastatin dosing |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |