The study objective is to investigate the pharmacodynamics (effects of a drug product) when
switching the treatment from warfarin to rivaroxaban.
84 young, healthy subjects will participate; they will be treated following a randomized,
parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind
(Treatments A and B) design.
The first two groups (A, B) will receive warfarin for approximately one week to adjust their
blood coagulation values to a specific level, i.e. to maintain an INR (international
normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant
treatment.
The first group (A) will receive rivaroxaban for four days, the second group (B) will take
placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize
the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin
but will receive rivaroxaban for four days.
Phase:
Phase 1
Details
Lead Sponsor:
Bayer
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Rivaroxaban Vitamin K Vitamin K 1 Vitamins Warfarin