TABLE 2.
Pharmacokinetic parameters of adalimumab in each group (Mean [CV%] or median [min, max]).
| HOT-3010 group (N = 66) | Adalimumab group (N = 68) | p | GMR (90%CI) | GMR (90%CI)a | Re-estimated size | |
|---|---|---|---|---|---|---|
| T max*(h) | 144.00 (96.00, 336.02) | 144.00 (48.00, 336.83) | 0.45 | — | — | — |
| C max (ng/ml) | 3904.35 (34.78) | 3790.65 (33.55) | 0.61 | 102.22 (92.06–113.49) | 101.91 (91.72–113.23) | 84 |
| AUC0-t (hr*ng/mL) | 2335328.82 (39.58) | 2272030.28 (29.77) | 0.65 | 98.47 (87.60–110.68) | 98.82 (87.85–111.17) | 104 |
| AUC0-∞(hr*ng/mL) | 2512012.43 (39.79) | 2461783.86 (31.15) | 0.74 | 98.27 (87.70–110.11) | 98.65 (87.98–110.62) | 106 |
| t1/2(h) | 285.94 (50.49) | 308.23 (47.56) | 0.38 | — | — | — |
| CL/F (mL/h) | 19.23 (50.26) | 18.48 (44.87) | 0.63 | — | — | — |
| Vz/F (mL) | 6847.75 (41.71) | 7208.08 (33.13) | 0.43 | — | — | — |
a
HOT-3010/adalimumab after excluding Subject no.004, whose ADA was positive pre-dose.