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Aims  This study investigated relevant pharmacodynamic and pharmacokinetic parameters during the transition from warfarin to rivaroxaban in healthy male subjects.    Methods  Ninety‐six healthy men were randomized into the following three groups: warfarin [international normalized ratio ( INR ) 2.0–3.0] transitioned to rivaroxaban 20 mg once daily (od; group  A ); warfarin ( INR  2.0–3.0) followed by placebo od (group  B ); and rivaroxaban alone 20 mg od (group  C ) for 4 days. Anti‐factor  X a activity, inhibition of factor  X a activity, prothrombin time ( PT ), activated partial thromboplastin time,  HepTest , prothrombinase‐induced clotting time, factor  VIIa  activity, factor  IIa  activity, endogenous thrombin potential and pharmacokinetics were measured.    Results  An additive effect was observed on the  PT  and  PT / INR  during the initial transition period. The mean maximal prolongation of  PT  was 4.39‐fold [coefficient of variation ( CV ) 18.03%; range 3.39–6.50] of the baseline value in group  A , compared with 1.88‐fold ( CV  10.35%; range 1.53–2.21) in group  B  and 1.57‐fold ( CV  9.98%; range 1.37–2.09) in group  C . Rivaroxaban had minimal influence on the  PT / INR  at trough levels. Inhibition of factor  X a activity, activated partial thromboplastin time and endogenous thrombin potential were also enhanced, but to a lesser extent. In contrast, the effects of rivaroxaban on anti‐factor  X a activity,  HepTest  and prothrombinase‐induced clotting time were not affected by pretreatment with warfarin.    Conclusions  Changes in pharmacodynamics during the transition from warfarin to rivaroxaban vary depending on the test used. A supra‐additive effect on  PT / INR  is expected during the initial period of transition, but pretreatment with warfarin does not influence the effect of rivaroxaban on anti‐factor  X a activity.

Pharmacodynamics and pharmacokinetics during the transition from warfarin to rivaroxaban: a randomized study in healthy subjects