TABLE 1

Pharmacokinetic parameters of dabigatran, calculated from free dabigatran concentration/time data, following p.o. administration of 200 mg of [14C]dabigatran etexilate (2.8 MBq) or i.v. infusion of 5 mg of [14C]dabigatran (2.8 MBq) in healthy male volunteers (n = 5 per treatment)

Results are presented as mean ± S.D.




5 mg of [14C]Dabigatran i.v.

200 mg of [14C]Dabigatran Etexilate p.o.
Cmax (ng/ml) 187.0 ± 37.4 145.0 ± 45.2
Tmax (h) 0.5 ± 0.02 1.15 ± 0.49
AUC0-24 (ng · h/ml) 490.0 ± 55.5 839.0 ± 209.0
AUC0-∞ (ng · h/ml) 526.0 ± 63.0 930.0 ± 232.0
t1/2 (h) 7.31 ± 0.74 9.4 ± 2.1
Cltot (ml/min) 155.0 ± 20.4 N.A.
Cltot/F (ml/min) N.A. 3020.0 ± 614.0
Vss (1) 68.6 ± 9.76 N.A.
Vz/F (1) N.A. 2400 ± 513
MRT (h) 7.4 ± 0.85 9.7 ± 1.7
F (%)
N.A.
5.97
  • N.A., not applicable.