Table 2.
Pharmacokinetic parameters after administration of single 90 μg/kg doses of original rFVIIa or rFVIIa-RT in a randomized crossover study48
| Mean (SD) pharmacokinetic parameter |
rFVIIa |
|
|---|---|---|
| Original (n = 22) | RT (n = 22) | |
| AUC0-t, h/IU/mL | 122.04 (18.03) | 113.26 (17.36)a |
| Cmax, IU/mL | 55.44 (7.89) | 52.83 (7.31) |
| AUC0–30, h/IU/mL | 122.05 (18.01) | 113.26 (17.36) |
| t½, h | 3.48 (0.27) | 3.54 (0.28) |
| Mean residence time, h | 2.97 (0.26) | 3.05 (0.27) |
| CL, mL/h/kg | 37.63 (5.99) | 40.43 (6.23) |
| Vc, mL/kg | 82.68 (12.50) | 86.36 (12.31) |
| Vss, mL/kg | 111.31 (17.52) | 122.96 (20.42) |
Notes:
a
P = 0.1076 for RT vs original formulation.
Copyright © 2007, John Wiley and Sons. Reproduced with permission from Bysted et al.48
Abbreviations: rFVIIa, activated recombinant factor VII; rFVIIa-RT, room temperature stable rFVIIa; SD, standard deviation; AUC, area under the curve; Cmax, maximal concentration; t½, half-life; CL, clearance; Vc, volume of distribution in the central compartment; Vss, volume of distribution at steady state.