Table 3.
Pharmacokinetic Parameters of EMD 273063
| Peak Concentration (ng/mL)*† |
Clearance (L/h)
|
Half-Life (h)
|
AUC (ng/mL*h)*‡ |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose (mg/m2) | No. of Patients | Mean | SD | Mean | SD | Mean | SD | Mean | SD |
| 0.8 | 3 | 185 | 31 | 1.39 | 0.45 | 2.7 | 0.21 | 1,138 | 248 |
| 1.6 | 6 | 696 | 390 | 0.67 | 0.16 | 3.5 | 1.10 | 5,106 | 2,540 |
| 3.2 | 6 | 1,490 | 693 | 0.66 | 0.22 | 3.8 | 0.45 | 11,448 | 4,970 |
| 4.8 | 6 | 3,965 | 2,001 | 0.39 | 0.11 | 4.2 | 1.25 | 25,529 | 6,794 |
| 6.0 | 6 | 6,339 | 1,519 | 0.33 | 0.09 | 3.8 | 0.86 | 38,944 | 12,294 |
| 7.5 | 6 | 5,514 | 2,808 | 0.38 | 0.11 | 3.9 | 0.66 | 40,870 | 18,958 |
Abbreviations: AUC, area under the curve; SD, standard deviation.
*
Peak concentration and AUC were obtained at course 1, day 1. Values shown are mean and SD for all patients at each dose level.
†
The association between maximal concentration and dose level was highly significant (P < .001).
‡
The association between AUC and dose level was highly significant (P < .001).