Absence of Clinically Relevant Interactions between Rivaroxaban - an Oral, Direct Factor Xa Inhibitor - and Digoxin or Atorvastatin in Healthy Subjects

• Published in: Journal of international medical research Vol. 40; no. 5; pp. 1688 - 1707
• Main Authors: Kubitza, D, Becka, M, Roth, A, Mueck, W
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.10.2012
• Subjects: Adult; Anti-Arrhythmia Agents - adverse effects; Anti-Arrhythmia Agents - pharmacokinetics; Anti-Arrhythmia Agents - pharmacology; Atorvastatin Calcium; Cross-Over Studies; Digoxin - adverse effects; Digoxin - pharmacokinetics; Digoxin - pharmacology; Drug Interactions; Drug Therapy, Combination - adverse effects; Factor Xa Inhibitors; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - pharmacokinetics; Fibrinolytic Agents - pharmacology; Headache - chemically induced; Heptanoic Acids - adverse effects; Heptanoic Acids - pharmacokinetics; Heptanoic Acids - pharmacology; Humans; Male; Middle Aged; Morpholines - adverse effects; Morpholines - pharmacokinetics; Morpholines - pharmacology; Pyrroles - adverse effects; Pyrroles - pharmacokinetics; Pyrroles - pharmacology; Rivaroxaban; Self Administration; Thiophenes - adverse effects; Thiophenes - pharmacokinetics; Thiophenes - pharmacology; Young Adult; Atorvastatin; Rivaroxaban; Pharmacodynamics; Digoxin; Pharmacokinetics; Drug interactions

Objective: To investigate potential interactions between rivaroxaban, an oral direct Factor Xa inhibitor approved for the management of thromboembolic disorders, and digoxin or atorvastatin. Methods: Two randomized, phase 1 clinical trials were undertaken in healthy men to assess pharmacokinetic and...