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. 2022 Sep 27;11(1):2315–2325. doi: 10.1080/22221751.2022.2117094

Table 4.

Summary of serum PK parameters for CT-P63 (PK Set).

  CT-P63 600 mg (n = 6) CT-P63 900 mg (n = 6) CT-P63 1800 mg (n = 6)
Cmax (μg/mL) 191.3 (17.9) 282.4 (11.7) 482.8 (9.0)
Tmax (h), median (range) 1.56 (1.08–13.08) 1.59 (1.10–5.07) 2.08 (1.10–13.07)
t½ (h) 578.4 (21.0) 643.3 (19.0) 600.1 (20.9)
CL (mL/h) 8.514 (29.2) 8.674 (23.4) 10.01 (21.6)
AUC0–inf (h*μg/mL) 70470 (29.2) 103800 (23.4) 179900 (21.6)
AUC0–last (h*μg/mL) 65020 (25.9) 93790 (19.9) 159700 (17.6)*
%AUCext (%) 6.782 (67.4) 8.836 (50.0) 8.995 (71.5)
λz (1/h) 0.001198 (21.0) 0.001078 (19.0) 0.001155 (20.9)
Vss (mL) 6572 (12.4) 7261 (12.4) 8045 (5.6)
Dose-normalized      
Cmax/dose (μg/mL/mg) 0.3188 (17.9) 0.3138 (11.7) 0.2682 (9.0)
AUC0–inf/dose (h*μg/mL/mg) 117.5 (29.2) 115.3 (23.4) 99.94 (21.6)
AUC0–last/dose (h*μg/mL/mg) 108.4 (25.9) 104.2 (19.9) 88.70 (17.6)*

Notes: All data are geometric mean (gCV%) unless otherwise stated.

AUC0–inf, area under the concentration–time curve from time zero to infinity; AUC0–last, area under the concentration–time curve from time zero to the last quantifiable concentration; %AUCext, percentage of AUC0–inf obtained by extrapolation; CL, total body clearance; Cmax, maximum serum concentration; EOS, end-of-study; gCV, geometric coefficient of variation; λz, terminal elimination rate constant; PK, pharmacokinetic; t½, terminal elimination half-life; Tmax, time to maximum serum concentration; Vss volume of distribution at steady state.

*One patient in the CT-P63 1800 mg group was excluded from AUC0–last and AUC0–last/dose calculations because they were lost to follow-up at EOS visit.