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Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (R)(T) | Active Comparator | Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg |
|
| (T)(R) | Active Comparator | Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl, | PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, M.D, Ph.d | Division of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea |
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| Fimasartan | Drug | Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg |
|
| ID | Term |
|---|---|
| C558933 | fimasartan |
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