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| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
| Yonsei University | OTHER |
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To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hepatic impairment patients | Experimental | Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C) |
|
| Healthy volunteers | Active Comparator | healthy volunteers group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fimasartan | Drug | single administration of fimasartan 120mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics of fimasartan | AUC, Cmax, Tmax, T1/2, CL/F of fimasartan | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h |
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Inclusion Criteria:
<Hepatic impairment patient>
<Healthy volunteer>
Exclusion Criteria:
<Hepatic impairment patient>
<Healthy volunteer>
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| Name | Affiliation | Role |
|---|---|---|
| Minsoo Park, PhD | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24084213 | Derived | Kim CO, Lee HW, Oh ES, Seong SJ, Kim DY, Lee J, Ahn SH, Yoon YR, Cho CM, Park MS. Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan. J Cardiovasc Pharmacol. 2013 Dec;62(6):524-9. doi: 10.1097/FJC.0000000000000010. |
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| fimasartan |
| Drug |
single administration of fimasartan 120mg |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
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