Table 5.

Mean plasma BAY 43-9006 pharmacokinetic variables after dosing for 7 d in cycle 1

Dose level (mg bid)AUC0-12 (μg·h/mL), n
Cmax (μg/mL), n
tmax (h), n
t1/2 (h), n
Geo mean (∼CV%,)
Geo mean (∼CV%,)
Median (range)
Geo mean (∼CV%,)
Day 1Day 7Day 1Day 7Day 1Day 7Day 7
1001333333
6.8 (NC)24.4 (76.3)1.0 (31.8)3.5 (73.7)6.0 (2.0-7.3)2.0 (2.0-2.0)38.1 (47.8)
2001333333
6.1 (NC)19.1 (16.9)0.8 (85.6)2.6 (8.6)6.0 (2.0-6.0)2.0 (0.5-24.1)20.1 (12.8)
4002444443
18.0 (5.3)56.6 (90.5)2.3 (37.3)6.2 (106.7)9.2 (2.0-12.0)2.0 (0.0-6.0)20.0 (21.9)
6003666666
21.0 (81.3)64.8 (76.8)2.7 (61.2)6.6 (70.9)6.0 (2.0-9.9)1.5 (0.1-6.5)24.3 (21.0)
8002333333
23.7 (14.7)92.8 (32.4)4.6 (7.4)12.3 (32.8)10.0 (2-12.0)2.1 (1.0-24.0)32.1 (34.7)
  • NOTE: ∼CV% is the approximate coefficient of variation. AUC0-12 is the AUC value over the dosing interval, after 7 d of dosing, over a nominal period of 12 h (the exact time interval may be different for each patient). For tmax, the median, instead of geometric mean, and range, instead of ∼CV%, are presented (n = number of observations).

    Abbreviations: Geo mean, geometric mean; NC, not calculated.