PulseExploreJournal ClubResearchersJournals
Instagram
HomeJournal ClubExplore
Synapse
⌘+K
Synapse
September 9, 2013Clinical Pharmacology in Drug Development

Bioavailability and Safety of the Factor Xa Inhibitor Edoxaban and the Effects of Quinidine in Healthy Subjects

View Full Paper
Ask AI
Bookmark
Share

Why the study?

What is the absolute bioavailability of edoxaban and the effect of the P-glycoprotein inhibitor quinidine on its pharmacokinetics in healthy subjects?

Population

36 healthy volunteers

Design

RCT, Randomized sequence

Key result

Edoxaban oral absolute bioavailability was 61.8% in healthy volunteers, and concomitant quinidine increased total edoxaban exposure by ~35%.

Authors

NMNobuko MatsushimaFLFrank LeeTSToshiyuki Sato

Discussion

Loading...

Member takes

Overview

Increased edoxaban exposure with quinidine warrants P-gp interaction caution; extends bioavailability data for NOAC dosing in atrial fibrillation.

Study Design

Type

RCT (n=36)

Randomization

randomized sequence

Structured PICO

What is the absolute bioavailability of edoxaban and the effect of the P-glycoprotein inhibitor quinidine on its pharmacokinetics in healthy subjects?

P
Population
36 healthy volunteers
I
Intervention
Three treatments in a randomized sequence: single oral 60-mg edoxaban dose, single intravenous 30-mg edoxaban dose, and concomitant single intravenous 30-mg edoxaban dose with quinidine 300 mg every 8 hours for 4 days
O
Outcome
Absolute bioavailability of edoxabansurrogate

Edoxaban has an absolute oral bioavailability of 61.8% in healthy subjects, and its exposure is moderately increased by the P-glycoprotein inhibitor quinidine.

Cite This Study

Matsushima et al. (2013) conducted an RCT in Healthy volunteers (n=36). Edoxaban vs. Different administration routes and concomitant quinidine was evaluated on Absolute bioavailability of edoxaban. Edoxaban oral absolute bioavailability was 61.8% in healthy volunteers, and concomitant quinidine increased total edoxaban exposure by ~35%.

synapsesocial.com/papers/6a0e989b3903c9222ec84939https://doi.org/10.1002/cpdd.53
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers2010 · 454 citations
  2. 2A randomized trial of the safety, pharmacokinetics and pharmacodynamics of edoxaban, an oral factor <scp>Xa</scp> inhibitor, following a switch from warfarin2012 · 42 citations
  3. 3Pharmacokinetics and Pharmacodynamics of Edoxaban, a Non-Vitamin K Antagonist Oral Anticoagulant that Inhibits Clotting Factor Xa2015 · 230 citations
  4. 4Drug-Drug Interaction Studies of Cardiovascular Drugs Involving P-Glycoprotein, an Efflux Transporter, on the Pharmacokinetics of Edoxaban, an Oral Factor Xa Inhibitor2013 · 227 citations
  5. 5Pharmacokinetics and Pharmacodynamics of the Nonvitamin K Antagonist Oral Anticoagulant Edoxaban When Administered Alone or After Switching from Rivaroxaban or Dabigatran Etexilate in Healthy Subjects2015 · 6 citations