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Table 2 Summary of pharmacokinetic parameters in Study 1 and Study 2

From: Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

  Geometric Mean Parameter Estimate (Geometric CV)a
Study 1 Study 2
FKB327
N = 65
RP
N = 65
FKB327
N = 65
RP
N = 65
n value n value n value n value
Cmax (ng/mL) 65 3920 (25.2) 65 3650 (29.5) 65 3920 (19.1) 65 3710 (17.5)
AUC0-t (h•ng/mL) 65 2,540,000 (36.7) 65 2,180,000 (41.3) 65 2,620,000 (38.5) 65 2,350,000 (33.7)
AUC0-∞ (h•ng/mL) 55 2,770,000 (37.5) 58 2,380,000 (41.9) 56 2,830,000 (40.6) 58 2,550,000 (35.9)
AUC0–360 (h•ng/mL) 65 1,170,000 (26.3) 65 1,070,000 (32.2) 65 1,130,000 (21.3) 65 1,080,000 (20.2)
T1/2 (h) 55 330.487 (53.7) 58 288.644 (58.2) 56 281.084 (60.8) 58 275.219 (61.8)
  1. aMeasured values (no correction for protein content of drugs) were used for the analysis in Study 1 and Study 2
  2. AUC0-∞ Area under the concentration-time curve from time zero to infinity; AUC0–360 Area under the concentration-time curve from time zero to 360 h; AUC0-t Area under the concentration-time curve from time zero to the last measurable concentration; Cmax Maximum serum concentration; CV Coefficient of variation; RP Reference product; T1/2 Half-life