Table 2.
Summary of PK data
| PK parameter | Geometric mean (range) | Ratio | 90% CI | |
|---|---|---|---|---|
| Hospira filgrastim | Amgen filgrastim | |||
| i.v. route (n = 20) | ||||
| AUC0–tlast, pg.hour/ml | 1,259,808 (827,253–1,882,329) | 1,316,067 (914,165–1,864,730) | 0.96 | 0.90–1.02a |
| C max, pg/ml | 288,450 (194,944–479,154) | 305,687 (198,410–935,835) | 0.94 | 0.84–1.07a |
| T max, hours | 0.62 (0.50–1.00) | 0.71 (0.50–3.00) | – | – |
| T 1/2, hours | 7.57 (3.22–15.37) | 8.06 (3.36–13.68) | 0.95 | 0.81–1.12a |
| AUC0–infinity, pg.hour/ml | 1,264,255 (832,227–1,888,906) | 1,319,602 (916,022–1,868,352) | 0.96 | 0.91–1.02a |
| λ z | 0.092 (0.045–0.216) | 0.086 (0.051–0.206) | – | – |
| Clearance, ml/hour/kg | 7.910 (5.294–12.016) | 7.578 (5.352–10.917) | – | – |
| s.c. route (n = 26) | ||||
| AUC0–tlast, pg.hour/ml | 946,611 (426,566–1,340,753) | 929,670 (671,388–1,248,375) | 1.02 | 0.95–1.09a |
| C max, pg/ml | 94,765 (49,602–159,675) | 90,754 (62,633–119,410) | 1.04 | 0.97–1.13a |
| Tmax, hours | 5.11 (3.00–8.00) | 5.06 (3.05–8.00) | – | – |
| T1/2, hours | 7.01 (5.29–11.26) | 6.91 (5.30–9.98) | 1.01 | 0.94–1.09a |
| AUC0–infinity, pg.hour/ml | 950,955 (427,687–1,344,385) | 933,847 (676,427–1,252,249) | 1.02 | 0.95–1.09a |
| λ z | 0.099 (0.062–1.131) | 0.100 (0.069–1.131) | – | – |
| Clearance, ml/hour/kg | 10.516 (7.438–23.382) | 10.708 (7.986–14.784) | – | – |
– not reported.
aThe 90% CI was within the predefined equivalence range of 0.80–1.25, demonstrating bioequivalence between the two agents