Table 3.
Parameter | Trabectedin | Doxorubicin | ||
---|---|---|---|---|
Level 1 (n = 6) | Level 2 (n = 12) | Level 1 (n = 6) | Level 2 (n = 12) | |
tmax, h | 2.68 ± 0.94 | 2.78 ± 0.66 | 4.38 ± 1.70 | 4.37 ± 1.80 |
Cmax, *pg/mL or **µg/mL | 8640 ± 1320* | 9890 ± 3150* | 19.8 ± 1.7** | 22.2 ± 3.0** |
AUC0–inf, *ng·h/mL or **µg·h/mL | 61.5 ± 7.4* | 83.7 ± 69.0* | 2542.0 ± 391.2** | 1941.2 ± 548.3** |
t½, h | 102.8 ± 27.8 | 124.9 ± 100.2 | 92.0 ± 15.3 | 61.0 ± 12.7 |
CL, *L/h or **mL/h | 21.5 ± 2.2* | 26.8 ± 9.3* | 17.7 ± 3.4** | 26.9 ± 9.1** |
Vdss, L | 1461 ± 456 | 1921 ± 727 | 2.26 ± 0.27 | 2.15 ± 0.35 |
All data are expressed as mean ± SD
AUC0–inf area under the concentration–time curve from zero to infinity, CL clearance, Cmax maximum concentration, SD standard deviation, t½ terminal half-life, tmax time to Cmax, Vdss volume of distribution at steady state