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The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days |
|
| Part B | Experimental | Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (fimasartan or linagliptin) x 7days | Drug | Part A: fimasartan, Part B: linagliptin |
|
| Measure | Description | Time Frame |
|---|---|---|
| [Part A] AUC of fimasartan | [Part A] Area under the curve(AUC) of fimasartan in steady state | 0~24 hour after drug administration |
| [Part A] Cmax of fimasartan | [Part A] Cmax of fimasartan in steady state | 0~24 hour after drug administration |
| [Part B] AUC of Linagliptin | [Part B] Area under the curve(AUC) of Linagliptin in Steady State | 0~24 hour after drug administration |
| [Part B] Cmax of linagliptin | [Part B] Cmax of linagliptin in steady state | 0~24 hour after drug administration |
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1. Inclusion Criteria (Total: 5):
2. Exclusion Criteria (Total: 19):
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, PhD | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32546973 | Derived | Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020. |
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| (fimasartan and linagliptin) x 7days | Drug | Part A & Part B: Co-administration of fimasartan and linagliptin |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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