Table 2.
Mean pharmacokinetic parameters after a single subcutaneous epoetin dose
| Treatment | AUC0–48, sd | δAUC0–48, sd | Cmax, sd | δCmax, sd | tmax, sd | t½, sd∗ |
|---|---|---|---|---|---|---|
| mIU/ml·h | mIU/ml·h | mIU/ml | mIU/ml | h | h | |
| HX575 | ||||||
| Mean | 2,793.4 | 2,356.6 | 98.694 | 89.572 | 11.68 | 17.93 |
| SD | 654.2 | 632.8 | 30.249 | 30.199 | 3.54 | 6.31 |
| Min | 1,752.7 | 1,464.5 | 53.401 | 45.778 | 6.00 | 8.30 |
| Median | 2,640.4 | 2,184.4 | 94.834 | 84.380 | 10.05 | 16.48 |
| Max | 4,097.2 | 3,684.2 | 170.570 | 165.567 | 24.00 | 37.41 |
| GeoM | 2,718.9 | 2,277.1 | 94.299 | 84.827 | – | 16.97 |
| GeoCV, % | 24.1 | 26.9 | 31.5 | 34.5 | – | 34.3 |
| Comparator | ||||||
| Mean | 3,031.2 | 2,624.6 | 109.700 | 101.154 | 11.95 | 18.54 |
| SD | 1,032.9 | 983.5 | 58.198 | 57.426 | 4.98 | 6.12 |
| Min | 1,686.3 | 1,227.7 | 47.019 | 37.353 | 6.00 | 7.81 |
| Median | 2,964.8 | 2,617.2 | 94.857 | 85.522 | 10.00 | 17.49 |
| Max | 6,563.7 | 6,331.2 | 352.790 | 347.929 | 24.00 | 32.94 |
| GeoM | 2,883.5 | 2,473.7 | 99.422 | 90.608 | – | 17.60 |
| GeoCV, % | 32.2 | 35.3 | 44.6 | 47.5 | – | 34.0 |
AUC0–48, sd = Area under total concentration curve from 0 to 48 h after single dose; δAUC0–48, sd = baseline-adjusted area under total concentration curve from 0 to 48 h after single dose; Cmax, sd = peak serum concentration after single dose; δCmax, sd = baseline- adjusted peak serum concentration after single dose; tmax, sd = time to Cmax, sd; t½, sd = terminal elimination half-life; SD = standard deviation; GeoM = geometric mean; GeoCV = coefficient of variation of GeoM.
∗
Calculated from 36 subjects (HX575) and 34 subjects (comparator). For all other parameters: n = 37.