TABLE 3

Metabolite balances in urine, bile, and feces (selected metabolites) after administration of [14C]rivaroxaban to rats, dogs, and humans in time interval analyzed


Sample

Species

Time

Route

%Dose in Time Interval

Radioactivity
Rivaroxaban
M-1
M-2
M-4
M-5
M-6
M-7
M-8/M-9
Totala
days % dose
Urine Rat 0-2 p.o.b 23.5 5.2 9.1 4.1 3.2 0.1 0.7 22.4
Rat 0-1 i.v.c 30.3 8.1 11.9 3.4 5.4 1.0 29.8
Dog 0-5 p.o. 52.0 7.9 8.5 7.8 15.7 0.6 0.5 0.9 1.9 43.8
Human 0-2 p.o. 65.4 36.2 13.1 0.7 7.6 0.9 0.3 3.7 2.1 64.6
Bile Rat 0-1 i.v.c 48.4 44.4 44.4
Feces Rat 0-1 i.v.c 12.9 2.9 5.5 2.5 1.9 <0.1 12.9
Dog 0-5 p.o. 42.5 1.1 26.2 2.8 2.1 2.1 2.9 0.7 37.9

Human
0-4
p.o.
26.4
7.3
8.9
1.1

1.6
0.9
2.9
1.6
24.3
  • a Unchanged rivaroxaban and known metabolites

  • b Intact rats.

  • c Bile duct-cannulated rats.