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Table 2.

Pharmacokinetic parameters of sorafenib and metabolites M‐2, M‐4, and M‐5: sorafenib following single dose and multiple dose of 200 mg and 400 mg geometric mean (coefficient of variation)

Sorafenib Parameter Unit 200 mg bid 400 mg bid
Child–Pugh A Child–Pugh B Child–Pugh A Child–Pugh B
Single n  7  6  6  8
Dose AUC mg*h/L 28.29 190.29 18.64 74.1 20.33 90.31 26.87 96.97
Day 1 AUC0–12 mg*h/L  5.02 190.36  2.75 61.06  3.82 86.06  3.11 88.16
Cmax mg/L  0.81 195.96  0.49 67.85  0.55 83.75  0.53 86.68
Tmax h  7 3–12 18 4–24  8 6–24 24 4–24
T1/2 H 25.14  30.13 30.44 35.67 22.28 12.49 27.2 45.19
Cycle 1 N  6  6  6  6
Day 14 AUC0–12 mg*h/L 25.52  75.04 15.28 55.26 33.47  60.13 29.45 59.44 §
Cmax mg/L  3.36  87.29  1.89 62.14  4.66  66.12  3.04 94.39
Cycle 1 N  6  6  6  5
Day 28 AUC0–12 mg*h/L 31.63 101.64 20 73.4 28.91  86.79 20.71 72.06
Cmax mg/L  4.22  92.32  3.32 78.65  3.32 113.47  4.01 79.12

Median (range),

n = 6,

§

n = 5. AUC0–12, area under the concentration–time curve for 0–12 h.