The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Rivaroxaban granule 10mg for one day
Rivaroxaban tablet 10mg for one day
Unnamed facility
Kumamoto, Kumamoto, Japan
Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Time frame: Multiple time point up to 3 day
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
Time frame: Multiple time point up to 3 day
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 30 day
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