Pharmacokinetic parameters obtained in humans after a single oral administration of 50 mg of [14C]sunitinib and in male and female Cynomolgus monkeys after a single oral administration of 6 mg/kg [14C]sunitinib
The plasma levels of radioactivity are expressed as nanograms equivalents per milliliter.
| Parameters | Human | Female Monkey | Male Monkey | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Radioactivity No.* | Sunitinib | M1 | Radioactivity | Sunitinib | M1 | Radioactivity | Sunitinib | M1 | |
| Cmax (ng/ml) | 67.4 ± 19.4 | 24.4 ± 4.0 | 6.2 ± 1.8 | 214 ± 26 | 83 ± 12 | 54 ± 5 | 243 ± 13 | 92 ± 10 | 67 ± 12 |
| tmax (h) | 8.0 ± 0 | 8.0 ± 0 | 6.7 ± 3.3 | 4.0 ± 0 | 4.0 ± 0 | 7.0 ± 2.0 | 8.0 ± 0 | 5.0 ± 2.0 | 8.0 ± 0 |
| AUC0-∞ (ng · h/ml) | 2537.1 ± 858.4 | 1063 ± 262 | 592.6 ± 91.4 | 5692 ± 1151 | 1099 ± 87 | 1272 ± 137 | 9095 ± 432 | 1453 ± 205 | 1383 ± 246 |
| t1/2 (h) | 28.2 ± 13.2 | 50.9 ± 6.7 | 93.2 ± 15.4 | 121 ± 2.0 | 16.0 | 19.0 ± 6.0 | 222.0 ± 40.0 | 18.0 ± 4.0 | 19.0 ± 8.0 |
| CL/F (l/h) | 23.5 ± 14.2 | 49.9 ± 14.0 | NA | NA | NA | NA | NA | NA | NA |
NA, not applicable; CL, clearance; F, bioavailability.
↵* Calculated from data up to 24 h after dose.