^* A randomised, single-blind, single-dose, 3-arm, parallel-group study to determine the PK equivalence of KANJINTI^® and trastuzumab in healthy male subjects. The primary objective was to evaluate bioequivalence of KANJINTI^® and trastuzumab in terms of AUCinf and Cmax (equivalence criteria: 90% CI for geometric mean ratio within 0.80–1.25).

AUC_inf = area under the concentration curve versus time from zero to infinity; AUC_last = area under the concentration curve from the time of dosing to the last measurable concentration; C_max = maximum serum concentration; PK = pharmacokinetic.