Parameter | Formulation A N = 17 | Formulation B N = 16 | Difference (%) | p | 90 % CI |
---|---|---|---|---|---|
AUC120(mUI·h/mL) | 4500 ± 2281 | 4654 ± 2221 | 5.1 | 0.49 | (0.71 – 1.27) |
AUC (mUI·h/mL) | 4667 ± 2319 | 4918 ± 2113 | 3.3 | 0.66 | (0.71 – 1.32) |
Cmax (mUI/ml) | 119.1 ± 56.4 | 119.7 ± 60.5 | 0.5 | 0.96 | (0.73 – 1.35) |
Tmax (h) | 13.9 ± 9.9 | 18.1 ± 14.9 | 23.2 | 0.08 | - |
λ(h-1) | 0.040 ± 0.018 | 0.037 ± 0.015 | 10.8 | 0.49 | (0.89 – 1.32) |
t1/2 (h) | 20.0 ± 7.9 | 22.5 ± 12.1 | 11.1 | 0.29 | (0.69 – 1.14) |
CAV | 0.027 ± 0.008 | 0.024 ± 0.007 | 8.0 | 0.38 | (0.94 – 1.31) |
F | 0.29 ± 0.14 | 0.31 ± 0.14 | 6.4 | 0.53 | (0.75 – 1.17) |
MRT (h) | 33.9 ± 10.7 | 42.3 ± 20.8 | 19.8 | 0.15 | - |
CL (mL/h·Kg) | 6.3 ± 0.3 | 6.3 ± 0.4 | 0.5 | 0.55 | (0.98 – 1.03) |
Vd (mL/Kg) | 182 ± 74 | 202 ± 107 | 10.0 | 0.67 | (0.70 – 1.15) |