Table 3.
Day | Dose (mg) | N(patients) | tmaxa (h) | Cmax (ng/mL) | Cmin (ng/mL) | AUC0-24 (ng h/mL) | t½ (h) | CL/F (L/h) | Vd/F (L) |
---|---|---|---|---|---|---|---|---|---|
Repeat doses on C1D8, C1D22, C2D8, C2D15 or C2D22 | 600 | 7 | 2 (2–2) | 2470 ± 328 | 230 ± 123 | 22100 ± 2450 | 8.22 ± 1.27 | 26.9 ± 2.85 | 320 ± 61.1 |
800 | 31 | 2 (2–4) | 2480 ± 679 | 312 ± 166 | 24700 ± 8580 | 8.25 ± 1.17 | 38.0 ± 22.2 | 454 ± 299 | |
1000 | 16 | 2 (1–6) | 2490 ± 666 | 499 ± 185 | 27200 ± 9210 | 8.45 ± 1.06 | 39.7 ± 9.20 | 477 ± 87.0 |
AUC0-24 area under the curve 0 to 24 h, C1 Cycle 1, CL/F apparent total clearance of the drug from plasma after oral administration, Cmax maximum plasma concentration, Cmin minimum plasma concentration, D8 Day 8 (of cycle), h hour, ID insufficient data, NA not available, PK pharmacokinetics, t½ elimination half-life, tmax time of maximum plasma concentration, Vd/F apparent volume of distribution.
aMedian (minimum-maximum).