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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
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Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G3041 | Experimental | Amlodipine orotate 10mg/Olmesartan medoxomil 40mg |
|
| SEVIKARĀ® | Active Comparator | Amlodipine besylate 10mg/Olmesartan medoxomil 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G3041 | Drug |
| ||
| SEVIKARĀ® |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h |
| Measure | Description | Time Frame |
|---|---|---|
| tmax, t1/2, AUCinf, CL/F, Vz/F | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h | |
| ĪAUEC24, ĪEmax, tEmax | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JW Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
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