Table 2.
PK Parameters for LZM003 and Reference Drug–PKAS
| PK Parameters | Mean ± SD (%CV) | |
|---|---|---|
| LZM003 (N = 47) | Reference Drug (N = 48) | |
| AUC0-∞ (hr*ng/mL) | 338.136 ± 141.2665 (41.78) | 340.733 ± 124.6080 (36.57) |
| AUC0–t (hr*ng/mL) | 316.169 ± 132.5797 (41.93) | 318.583 ± 118.3718 (37.16) |
| Cmax (ng/mL) | 6.838 ± 3.8923 (56.92) | 6.092 ± 2.6405 (43.35) |
| Tmax (hr)a | 16.000 (6.00, 28.00) | 19.955 (6.00, 32.00) |
| λz (1/hr) | 0.025 ± 0.0071 (29.01) | 0.019 ± 0.0050 (26.55) |
| t1/2 (hr) | 31.902 ± 15.9461 (49.99) | 39.716 ± 11.5495 (29.08) |
| CL (L/hr) | 0.867 ± 0.3710 (42.77) | 0.837 ± 0.3271 (39.08) |
| Vd (L) | 38.123 ± 18.4011 (48.27) | 47.216 ± 20.4491 (43.31) |
| F (%) | 100.780 ± 28.3496 (28.13) | |
Notes: aTmax was represented by a median (minimum, maximum).
Abbreviations: PKAS, pharmacokinetic analysis set; AUC0-∞, the area under the curve between 0 and infinity; AUC0–t, the area under the curve of the plasma concentration until the last concentration observed; Cmax, the peak of concentration; Tmax, time to Cmax; λz, rate constant of apparent terminal elimination; t1/2, terminal elimination half-life; CL, total body clearance; Vd, apparent volume of distribution; F, relative bioavailability; SD, standard deviation; CV, coefficient of variation.