Table 3.
0.4 mg/kg (N = 6) | 0.6 mg/kg (N = 6) | 0.9 mg/kg (N = 6) | |
---|---|---|---|
Cmax (ng/mL) | 1,330.0 (985.0, 1,710.0) | 1,170.0 (839.0, 1,440.0) | 3,060.0 (1,750.0, 3,560.0) |
AUC0-30 min (×104 min·ng/mL) | 0.59 (0.55, 0.71) | 0.83 (0.82, 0.85) | 1.59 (1.16, 1.78) |
AUC0-1 h (×104 min ng/mL) | 0.82 (0.74, 1.28) | 1.19 (1.14, 1.27) | 2.07 (1.55, 2.14) |
AUC0-t (×104 min·ng/mL) | 1.52 (1.36, 2.54) | 2.48 (2.26, 2.63) | 3.85 (3.25, 4.70) |
AUC0-∞ (×104 min·ng/mL) | 1.63 (1.47, 3.03) | 2.54 (2.44, 2.75) | 4.24 (3.37, 5.15) |
Tmax (min) | 2.00 (2.00, 3.00) | 2.00 (2.00, 3.00) | 2.00 (1.00, 2.00) |
T1/2z (min) | 125.3 (111.8, 148.0) | 105.6 (100.1, 125.1) | 116.3 (107.9, 602.2) |
Vz (×103 mL/kg) | 4.3 (2.1, 5.0) | 3.6 (3.5, 4.0) | 4.3 (4.3, 15.2) |
CL (mL/min/kg) | 24.6 (13.2, 27.2) | 23.7 (21.8, 24.6) | 21.7 (17.5, 26.7) |
λz (×10-3 L/min) | 5.6 (4.7, 6.2) | 6.6 (5.5, 6.9) | 6.0 (1.2, 6.4) |
MRT0-∞ (min) | 141.7 (113.1, 142.3) | 126.1 (122.0, 132.8) | 156.4 (108.6, 404.5) |
AUC%extrap in % | 7.7 (6.7, 12.4) | 4.8 (4.4, 7.3) | 7.3 (3.5, 9.2) |
Cp LORverbal * | 809.5 (149.0, 2,030.0) | 768.5 (53.5, 2,960.0) | 1,750.0 (386.0, 7,900.0) |
Cp RORverbal * | 233.0 (197.0, 242.0) | 261.0 (224.0, 362.0) | 315.0 (255.0, 361.0) |
Data are presented as the median and range; the remaining data are presented as medians (1st to 3rd) quartiles.
Cmax, maximum plasma concentration; AUC, area under the concentration; Tmax, time of maximum plasma concentration; T1/2z, terminal elimination half-life; CL, clearance; LORverbal, loss of verbal response; RORverbal, recovery of verbal response.