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The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
This is an open-label, randomized, 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/Amlodipine and co-administration of Fimasartan and Amlodipine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period. |
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| Sequence B | Experimental | Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period. |
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| Sequency C | Experimental | Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan/Amlodipine | Drug | Treatment B |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUClast of Fimasartan, Amlodipine | Time Frame: 0~144 hour after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, PhD | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fimasartan + Amlodipine |
| Drug |
Treatment A |
|