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| Name | Class |
|---|---|
| Kyunghee university hospital A Drug Analytical Laboratory | UNKNOWN |
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An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.
And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.
At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment AB | Other | Treatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination |
|
| Treatment BA | Other | Treatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug |
| ||
| Amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| (Cmax) | 0~144 hour after medication | |
| (AUClast) | 0~144 hour after medication |
| Measure | Description | Time Frame |
|---|---|---|
| (AUCinf) | 0~144 hour after medication | |
| (tmax) | 0~144 hour after medication | |
| (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| seunghoon han, M.D., Ph.D. | The Catholic university St. Mary hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic university St. Mary hospital | Seoul | 137-701 | South Korea |
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|
| Fimasartan/Amlodipine combination | Drug |
|
| 0~144 hour after medication |
| 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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