Table 4.
Comparison of Secondary Pharmacokinetic Parameters
| PK Parameters | N1:N2 | Median (Q1, Q3) of CMAB015 Group | Median (Q1, Q3) of Secukinumab Group | Statistical Magnitude | P value |
|---|---|---|---|---|---|
| Tmax (h) | 65:65 | 95.9833 (95.9833, 119.9833) | 95.9833 (95.9833, 191.9833) | 1.967[T] | 0.051[T] |
| t1/2 (h) | 62:65 | 611.2085 (540.9398, 687.5034) | 648.8537 (577.4123, 692.8254) | −1.681[T] | 0.095[T] |
| λz (h−1) | 62:65 | 0.0011 (0.0010, 0.0013) | 0.0011 (0.0010, 0.0012) | 1.660[T] | 0.099[T] |
| CL/F (mL/h) | 62:65 | 7.2066 (6.6033, 8.1680) | 6.9879 (6.1492, 8.2442) | 0.991[T] | 0.324[T] |
| Vd/F (mL) | 62:65 | 6556.1400 (5804.1877, 7601.4152) | 6722.4651 (5682.6037, 7580.4246) | −0.234[T] | 0.815[T] |
Notes: N1: Subjects of CMAB015 group; N2: Subjects of secukinumab group. [T] Wilcoxon rank-sum test for two-sided P-values based on t-distribution approximation. 3 Subjects in CMAB015 group had AUC_%Extrap > 20%, then the respective other PK parameters (t1/2, λz, CL/F, Vd/F) were not included in the comparison.