Dose-normalised MTX PK parameters by treatment (PK analysis population)
| Cmax (ng/mL) | tmax (h) | λz (L/h) | t½ (h) | AUC0–24h (ng·h/mL) | AUC0–inf (ng·h/mL) | |
|---|---|---|---|---|---|---|
| Oral MTX (n=47) | ||||||
| Mean (SD) | 22.697 (7.4967) | 1.388 (0.8378) | 0.188 (0.0333) | 3.804 (0.6574) | 107.64 (37.732) | 109.47 (39.190) |
| CV% | 33.0 | 60.4 | 17.7 | 17.3 | 35.1 | 35.8 |
| Geometric mean | 21.586 | – | – | – | 101.73 | 103.23 |
| Geometric CV% | 32.7 | – | – | – | 34.6 | 35.3 |
| SC MTXAI (abdomen and thigh, n=96) | ||||||
| Mean (SD) | 20.222 (7.1509) | 1.523 (0.9175) | 0.184 (0.0331) | 3.887 (0.7017) | 135.87 (44.274) | 138.69 (46.477) |
| CV% | 35.4 | 60.3 | 18.0 | 18.1 | 32.6 | 33.5 |
| Geometric mean | 19.081 | – | – | – | 129.38 | 131.72 |
| Geometric CV% | 35.1 | – | – | – | 31.9 | 32.8 |
λz, apparent terminal rate constant; AUC0–24, area under the concentration versus time curve from 0 to 24 h; AUC0–inf, area under the concentration versus time curve from time 0 to infinity; Cmax, maximum observed concentration; CV%, coefficient of variation percentage; MTX, methotrexate; MTXAI, methotrexate auto-injector; PK, pharmacokinetic; t½, terminal half-life; tmax, time to reach maximum observed concentration.