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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 |
|---|---|---|---|
| Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg) | Active Comparator | Exforge® 10/160 |
|
| G-0081 (Amlodipine orotate 10mg / Valsratan 160mg) | Experimental | G-0081 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exforge® | Drug |
| ||
| G-0081 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf, Tmax, t1/2, % AUCextra | AUCinf = AUClast + Clast/λz %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100 t1/2 = 0.693/λz | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K S Park, MD, PhD | Head of Clinical Development, Clinical Trials Center Severance Hospital | Principal Investigator |
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| Drug |
|
| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017311 | Amlodipine |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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