Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects.

ABSTRACT:

Aims

The primary objective was to explore the pharmacodynamic changes during transition from rivaroxaban to warfarin in healthy subjects. Safety, tolerability and pharmacokinetics were assessed as secondary objectives.

Methods

An open label, non-randomized, sequential two period study. In treatment period 1 (TP1), subjects received rivaroxaban 20 mg once daily (5 days), followed by co-administration with a warfarin loading dose regimen of 5 or 10 mg (for the 10 mg regimen, the dose could be uptitrated to attain target international normalized ratio [INR] ≥2.0) once daily (2-4 days). When trough INR values ≥2.0 were attained, rivaroxaban was discontinued and warfarin treatment continued as monotherapy (INR 2.0-3.0). During treatment period 2, subjects received the same warfar

SUBMITTER: Moore KT 

PROVIDER: S-EPMC4456123 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature