Table 2.
Parameter | Geometric Mean | Geometric CV (%) | Arithmetic Mean | Arithmetic SD | Min | Median | Max |
---|---|---|---|---|---|---|---|
AUC0‐24 (μg · h/L) | 89.2 | 23.5 | 91.3 | 20.4 | 53.1 | 135 | |
AUC0‐24,md (μg · h/L) | 258 | 39.8 | 276 | 109 | 148 | 505 | |
Cav,md (μg/L) | 10.8 | 39.8 | 11.5 | 4.55 | 6.18 | 21.0 | |
Cmax (μg/L) | 12.1 | 29.8 | 12.5 | 3.04 | 5.77 | 15.8 | |
Cmax,md (μg/L) | 22.5 | 27.8 | 23.3 | 6.73 | 16.0 | 35.4 | |
Cmin,md (μg/L) | 7.52 | 45.5 | 8.22 | 3.83 | 4.14 | 15.7 | |
tmax (h) | 1.00 | 1.50 | 6.00 | ||||
tmax,md (h) | 1.00 | 1.50 | 2.50 | ||||
t1/2,md (h) | 43.4 | 22.9 | 44.5 | 10.3 | 30.8 | 66.8 | |
tlast,md (h) | 168 | 336 | 336 | ||||
RAAUC | 2.89 | 26.7 | 2.98 | 0.767 | 1.67 | 4.66 | |
RACmax | 1.86 | 25.2 | 1.92 | 0.554 | 1.43 | 3.36 | |
CLmd/F (L/h) | 7.75 | 39.8 | 8.27 | 3.10 | 3.96 | 13.5 |
AUC, area under the concentration vs time curve; AUC0‐24, AUC from time zero to 24 h after dosing; Cav,md, average concentration; Cmax, maximum observed concentration; Cmin,md, minimum observed concentration above lower limit of quantitation in the dose interval after multiple dosing; CLmd/F, apparent oral clearance calculated from dose and AUC0‐24,md; CV, coefficient of variation; md, multiple dose; RAAUC, accumulation ratio calculated as AUC0‐24,md/AUC0‐24; RACmax, accumulation ratio calculated as Cmax,md/Cmax; SD, standard deviation; t1/2,md, terminal half‐life after multiple dose; tlast,md, time of last observed concentration value above lower limit of quantitation; tmax, time to reach Cmax.
Data are presented on the pharmacokinetic analysis set (N = 11).