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This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.
An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID1801 | Active Comparator | qd daily for 6days Intervention: Drug: administration of ID1801 for 6days. |
|
| ID1803 | Active Comparator | qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. |
|
| ID1801 and ID1803 | Experimental | qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID1803 | Combination Product | Amlodipine 10mg/Valsartan 160mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCÏ„ | 0~72hours |
| Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss | 0~72hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCÏ„, Cmax,ss | N-desmethyl rosuvastatin, total ezetimibe: AUCÏ„ | 0~72hours |
| Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCÏ„, Cmax,ss |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID1801 |
| Combination Product |
Ezetimibe 10mg/Rosuvastatin Ca 20.8mg |
|
| ID1803+ID1801 | Combination Product | Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg |
|
N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss |
| 0~72hours |
| Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss | 0~72hours |
| Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss | 0~72hours |
| t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2 | 0~72hours |
| CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F | 0~72hours |
| Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F | 0~72hours |
| PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF | 0~72hours |
| D009750 | Nutritional and Metabolic Diseases |