Table 3.
PK Parameters by Gender Classification–PKAS
| PK Parameters | Mean ± SD (%CV) | |||
|---|---|---|---|---|
| Male (N = 24) | Female (N = 24) | |||
| LZM003 (N = 24) | Reference Drug (N = 24) | LZM003 (N = 23) | Reference Drug (N = 24) | |
| AUC0-∞ (hr*ng/mL) | 351.79 ± 150.14 (42.68) | 337.65 ± 118.23 (35.02) | 323.89 ± 133.21 (41.13) | 343.82 ± 133.16 (38.73) |
| AUC0–t (hr*ng/mL) | 322.28 ± 136.03 (42.21) | 319.96 ± 117.18 (36.63) | 309.79 ± 131.63 (42.49) | 317.21 ± 122.05 (38.48) |
| Cmax (ng/mL) | 7.30 ± 4.35 (59.58) | 6.85 ± 2.86 (41.73) | 6.35 ± 3.38 (53.16) | 5.33 ± 2.21 (41.39) |
| Tmax (hr)a | 15.99 (6.03, 28.00) | 15.99 (6.00, 28.00) | 16.00 (6.00, 28.00) | 23.99 (12.00, 32.00) |
| λz (1/hr) | 0.03 ± 0.01 (33.15) | 0.02 ± 0.01 (24.26) | 0.02 ± 0.01 (21.24) | 0.02 ± 0.00 (22.76) |
| t1/2 (hr) | 32.26 ± 21.31 (66.06) | 35.02 ± 9.59 (27.39) | 31.53 ± 7.52 (23.86) | 44.41 ± 11.60 (26.12) |
| CL (L/hr) | 0.84 ± 0.35 (41.422) | 0.84 ± 0.33 (39.53) | 0.90 ± 0.40 (44.47) | 0.83 ± 0.33 (39.47) |
| Vd (L) | 37.13 ± 22.03 (59.34) | 42.77 ± 21.00 (49.10) | 39.16 ± 14.08 (35.96) | 51.66 ± 19.30 (37.35) |
| F (%) | 107.19 ± 35.49 (33.11) | 94.09 ± 16.50 (17.54) | ||
Note: 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.