A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the PK/PD of Edoxaban

Summary

The aim of the study is to evaluate the effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults

Timeline

Start

2025-09-02

Primary completion

2025-09-24

Completion

2025-10

Publications

• 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.
• Background 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.