Table 2 Comparison of the PK primary and secondary endpoints in the PK set.

From: Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study

 

IBI301 (n = 82)

Rituximab (n = 89)

Geometric mean ratio (IBI301/rituximab) and 90% CI

AUC0-inf (day × µg/mL)

3,420 (978)

3,769 (1,005)

0.91 (0.85, 0.97)

AUC0-t (day × µg/mL)

3,226 (821)

3,534 (825)

0.91 (0.86, 0.97)

Cmax (µg/mL)

257 (58)

266 (55)

0.96 (0.92, 1.01)

  1. Data are expressed as mean ± SD.
  2. AUC area under the curve, Cmax maximum serum concentration, PK pharmacokinetics.