Table 7 Pharmacokinetic parameters (mean ± SD) calculated at day 1 and after the last day of treatment (steady-state) for human healthy volonteers treated for 7 days with subcutaneous injections of 2.5 and 5.0 μg/kg/day of BK0023 and Neupogen ® and for 5 days with subcutaneous injections of 10.0 μg/kg/day of BK0023 and Neupogen ®
Product and dosages | First treatment | Steady-state | ||
|---|---|---|---|---|
Cmax ng/ml | AUC0-24 hoursng/ml · hour | Cmax ng/ml | AUC0-24 hoursng/ml · hour | |
BK0023 2.5 μg/kg/day | 14.1 ± 1.4 | 113.6 ± 30.8 | 4.7 ± 1.6 | 32.8 ± 8.5 |
Neupogen 2.5 μg/kg/day | 13.4 ± 3.9 | 111.9 ± 30.3 | 5.1 ± 2.0 | 33.7 · 9.6 |
BK0023 5 μg/kg/day | 30.1 ± 9.1 | 276.7 ± 71.6 | 7.9 ± 4.4 | 51.2 ± 23.7 |
Neupogen 5 μg/kg/day | 32.2 ± 10.7 | 295.0 ± 86.8 | 9.0 ± 5.2 | 55.3 ± 27.0 |
BK0023 10 μg/kg/day | 60.1 ± 16.7 | 670.0 ± 154.9 | 25.1 ± 10.3 | 189.4 ± 69.7 |
Neupogen 10 μg/kg/day | 56.5 ± 11.8 | 671.5 ± 122.5 | 25.1 ± 9.0 | 188.4 ± 52.2 |