Table 4.
Pharmacokinetic analysis of KB on day 7
| Parameter | 0.06 mg/kg | 0.12 mg/kg | 0.24 mg/kg |
|---|---|---|---|
| AUC0–24h (h·n/mL) | 284.02 (37.24) | 541.55 (238.99) | 1236.08 (76.04) |
| AUC0–8h (h·n/mL) | 267.39 (34.13) | 507.27 (217.49) | 1166.30 (73.24) |
| AUC_%Extrap (%) | 0.96 (0.32) | 1.73 (2.03) | 0.97 (0.41) |
| AUCinf (h·ng/mL) | 286.74 (37.46) | 549.80 (239.24) | 1247.97 (73.43) |
| CLss (L/h) | 10.81 (2.22) | 12.59 (4.39) | 9.76 (0.79) |
| CLav,ss (ng/h) | 33.42 (4.27) | 63.41 (27.19) | 145.79 (9.16) |
| Cmax (ng/mL) | 146.91 (14.05) | 290.35 (69.47) | 629.98 (36.27) |
| Cmin_day7 (ng/mL) | 4.42 (1.34) | 10.62 (5.66) | 20.76 (3.06) |
| Kel (1/h) | 0.12 (0.03) | 0.11 (0.04) | 0.11 (0.02) |
| MRTinf,ss (h) | 2.04 (0.09) | 2.00 (0.43) | 2.06 (0.16) |
| PTF (%) | 429.36 (37.37) | 498.90 (186.75) | 418.96 (25.26) |
| R1 | 0.94 (0.05) | 1.08 (0.09) | 0.96 (0.09) |
| RAUC1 | 1.00 (0.05) | 1.15 (0.11) | 1.02 (0.09) |
| RAUC2 | 0.99 (0.06) | 1.13 (0.11) | 1.01 (0.09) |
| RCmax | 0.98 (0.08) | 1.08 (0.10) | 1.01 (0.08) |
| Tmax (h)# | 1.00 (1.00–1.00) | 1.00 (0.50–1.00) | 1.00 (1.00–1.00) |
Data was expressed in mean (standard deviation)
#Data was expressed in median (range)
AUC0–24h area under the plasma concentration–time curve from zero time to 24 h, AUC0–8h area under the plasma concentration–time curve from zero time to 8 h, AUC_%Extrap extrapolated area percentage, AUCinf area under the plasma concentration–time curve from the zero time to the estimated infinite time, CL apparent clearance rate, Cmax peak plasma concentration, Kel elimination rate constant, MRTinf average retention time, Tmax time to peak plasma concentration, Vd apparent volume of distribution, T1/2 elimination half-life, CLss apparent drug clearance rate, CLavss steady-state mean plasma concentration, Cmin_day7 trough concentration before the last dose, MRTinf, ss mean residence time, PTF fluctuation percentage, RAUC1 steady-state accumulation ratio expressed by AUC0–24h, RAUC1 = AUC0–24h (last dose)/AUC0–24h (first dose), RAUC2 steady accumulation ratio by AUC0–8h, RAUC2 = AUC0–8h (last dose)/AUC0–8h (first dose), R1 steady state accumulation ratio expressed by AUC, R1 = AUC0–8h (last dose)/AUCinf (first dose), RCmax steady-state accumulation expressed by Cmax, RCmax = Cmax (last dose)/Cmax (first dose)