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The aim of the study is to evaluate the effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults
Pharmacokinetics and pharmacodynamics of edoxaban without coadministration of grapefruit juice will be compared with those after administration of grapefruit juice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban and Grapefruit Juice | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban 60 MG [Lixiana] | Drug | Single administration of edoxaban |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum concentration | 24 hours post-dose |
| AUCinf | Area under the concentration-time curve from time of administration extrapolated to infinity | 24 hours post-dose |
| PT | prothrombin time | 24 hours post-dose |
| aPTT | activated partial thromboplastin time | 24 hours post-dose |
| TGA | Thrombin generation assay | 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Seoul | 08308 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23784266 | Background | Mendell J, Zahir H, Matsushima N, Noveck R, Lee F, Chen S, Zhang G, Shi M. Drug-drug interaction studies of cardiovascular drugs involving P-glycoprotein, an efflux transporter, on the pharmacokinetics of edoxaban, an oral factor Xa inhibitor. Am J Cardiovasc Drugs. 2013 Oct;13(5):331-42. doi: 10.1007/s40256-013-0029-0. | |
| 20081065 |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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| Edoxaban 60 MG [Lixiana] + Grapefruit Juice |
| Other |
Coadministration of edoxaban and grapefruit juice |
|
| Ogata K, Mendell-Harary J, Tachibana M, Masumoto H, Oguma T, Kojima M, Kunitada S. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol. 2010 Jul;50(7):743-53. doi: 10.1177/0091270009351883. Epub 2010 Jan 15. |
| 35950601 | Background | Liu L, Li X, Liu Y, Xu B, Li Y, Yuan F, Zhang P, Tu S, Hu W. Bioequivalence and Pharmacokinetic Study of 2 Edoxaban Tablets in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1440-1446. doi: 10.1002/cpdd.1156. Epub 2022 Aug 11. |
| 11451028 | Background | Wang EJ, Casciano CN, Clement RP, Johnson WW. Inhibition of P-glycoprotein transport function by grapefruit juice psoralen. Pharm Res. 2001 Apr;18(4):432-8. doi: 10.1023/a:1011089924099. |
| 24459178 | Background | Mikkaichi T, Yoshigae Y, Masumoto H, Imaoka T, Rozehnal V, Fischer T, Okudaira N, Izumi T. Edoxaban transport via P-glycoprotein is a key factor for the drug's disposition. Drug Metab Dispos. 2014 Apr;42(4):520-8. doi: 10.1124/dmd.113.054866. Epub 2014 Jan 23. |