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A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day. |
|
| Group 2 | Other | Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan/Atorvastatin Combination Tablet | Drug |
| ||
| Fimasartan |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin | 0~48 hour after medication | |
| Area under the curve(AUCt) of Fimasartan and Atorvastatin | 0~48 hour after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Atorvastatin | Drug |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |