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The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A fixed dose combination group | Experimental | A fixed dose combination of Fimasartan/Atorvastatin |
|
| Co-administration group | Active Comparator | Co-administration of Fimasartan and Atorvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan, Atorvastatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin | 0~48 hours after medication | |
| AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin | 0~48 hours after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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