Table 4.

Pharmacokinetic variables of BIBF 1120 after a single dose (day 1) and multiple dosing for 29 days

Single doseBIBF 1120 dose (mg)
150 (N = 3)200 (N = 12)250 (N = 6)
Cmax, ng/mL28.9 (61.5)52.0 (64.3)99.8 (70.3)
tmax*, h2.00 (1.00-6.00)2.98 (1.98-4.00)2.98 (1.00-4.07)
t1/2, h10.3 (15.8)10.2 (30.4)9.53 (10.8)
AUC0-12, ng·h/mL145 (88.3)233 (40.9)399 (64.9)
Multiple dosing150 (N = 3)200 (N = 7)250 (N = 3)
Cmax,ss, ng/mL38.8 (107)67.6 (74.3)62.9 (14.4)
tmax,ss, h2.00 (1.98-4.00)2.97 (1.98-3.98)2.00 (1.00-4.00)
t1/2,ss, h20.4 (55.3)19.9 (75.5)23.8 (39.4)§
AUCss, ng·h/mL207 (135)423 (66.2)411 (9.15)
Rac1.42 (35.4)1.70 (40.9)1.50 (79.0)

NOTE: Geometric mean (geometric coefficient of variation %).

Abbreviations: tmax,ss, time to reach maximum plasma concentrations at steady state; AUC, area under the curve.