Table 8.
Mean (±SD) of pharmacokinetic parameters of edotecarin after 1-h
Parameter | Edotecarin |
|
---|---|---|
Cycle 1 | Cycle 2 | |
Cmax (ng/ml)a | 79.0 ± 17.6 | 59.2± 27.3 |
Dose normalized Cmax (ng/ml)b | 13.2 ± 2.9 | 10.1 ± 4.4 |
Tmax (h) | 0.48 ± 0.22 | 0.83 ± 0.0 |
AUC (0–24) (ng/h/ml)a | 91.0 ± 21.6 | 65.3 ± 22.9 |
Dose normalized AUC (0–24) (h/ng/ml)b | 15.3 ± 3.6 | 11.1 ± 3.7 |
AUC (0-inf) (ng/h/ml)a | 124.5 ± 34.7 | 91.7 ± 31.9 |
Dose normalized AUC (0-inf) (ng/h/ml/)b | 20.7 ± 5.4 | 15.4 ± 5.1 |
CL (l/h/m2) | 51.3 ± 12.4 | 73.3± 29.7 |
Vss (l/m2) | 884.4 ± 296.0 | 1408.7± 999.7 |
T (h) | 25.3 ± 6.4 | 20.3 ± 4.2 |
AUC, area under the plasma concentration–time curve; CL, total body-clearance; Cmax, peak plasma concentration; t, half-life; tmax, time to maximum concentration.
Parameter following the 6 mg/m2 dose only.
Normalized to a 1 mg/m2 dose.