An Open-Label Crossover Study of the Pharmacokinetics of the 60-mg Edoxaban Tablet Crushed and Administered Either by a Nasogastric Tube or in Apple Puree in Healthy Adults

Clinical Pharmacokinetics
Kenneth DuchinTarundeep Kakkar

Abstract

Edoxaban is an orally active, direct factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation and for the treatment of venous thromboembolism. This study assessed the pharmacokinetics, safety, and tolerability of the edoxaban 60-mg tablet crushed and administered via a nasogastric tube in a water suspension or orally mixed in apple puree. This phase 1, open-label, crossover study randomized 30 healthy adults to receive three edoxaban treatment regimens (oral 60-mg edoxaban tablet, or 60-mg edoxaban tablet crushed and administered via a nasogastric tube or orally in apple puree) in one of six treatment sequences. Total edoxaban exposure was similar between the intact and crushed tablet regimens (mean area under the plasma concentration-time curve from time zero to infinity: whole tablet, 2132 ng·h/mL; nasogastric tube, 2021 ng·h/mL; apple puree, 2076 ng·h/mL). Mean maximum plasma concentration, area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, terminal half-life, and apparent total body clearance values were also similar. Time to maximum plasma concentration was significantly shorter for the nasogastric tube ...Continue Reading

References

Mar 17, 1990·BMJ : British Medical Journal·B R BloemA R Wintzen
Mar 30, 2005·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Patricia Cornish
Jun 11, 2010·Journal of Clinical Pharmacology·Jeanne MendellSatoshi Kunitada
May 15, 2015·Journal of Clinical Pharmacology·Dolly A ParasrampuriaSatoshi Kunitada
Oct 1, 2013·Clinical Pharmacology in Drug Development·Nobuko MatsushimaJeanne Mendell

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Citations

Mar 23, 2019·Expert Review of Cardiovascular Therapy·Carlos Escobar CervantesVivencio Barrios
Sep 13, 2020·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Rami A Al-Horani
Jan 14, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Victoria R Nachar, Allison J Schepers
Apr 26, 2021·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Jan SteffelUNKNOWN External reviewers
May 7, 2021·Deutsche medizinische Wochenschrift·Daniel DürschmiedChristoph Bode
Aug 28, 2021·International Journal of Molecular Sciences·Grzegorz GrześkJoanna Banach
Nov 19, 2021·European Heart Journal·UNKNOWN Task Force for the management of COVID-19 of the European Society of Cardiology
Dec 6, 2021·Cardiovascular Research·UNKNOWN Task Force for the management of COVID-19 of the European Society of Cardiology

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Methods Mentioned

BETA
pregnancy test
blood collection

Software Mentioned

SAS
WinNonlin

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