TABLE 4.
Treatment (SHR2285) | |||
---|---|---|---|
Group A n = 12 | Group B n = 13 | Group C n = 12 | |
Cmax, ng/mL | 5,030 (18.7) | 6,330 (25.1) | 7,050 (34.3) |
Tmax, h | 4.0 (1.5–4.0) | 2.5 (2.0–4.0) | 3.0 (2.5–4.0) |
AUCtau, h*ng/mL | 43,200 (23.3) | 48,000 (24.6) | 57,600 (37.2) |
AUC0-last, h*ng/mL | 76,000 (30.6) | 80,800 (30.5) | 102,000 (42.8) |
AUC0-inf, h*ng/mL | 82,100 (33.6) | 83,800 (31.0) | 111,000 (40.8) |
t1/2, h | 13.1 (2.52) | 12.3 (2.52) | 14.3 (3.69) |
CLss/F, L/h | 6.29 (1.53) | 8.69 (2.08) | 7.36 (3.12) |
Vss/F, L | 116 (20.7) | 151 (29.5) | 165 (119) |
Ctrough, ng/mL | 2,250 (32.0) | 2,220 (26.2) | 2,830 (45.7) |
Caverage, ng/mL | 3,600 (23.3) | 4,000 (24.6) | 4,800 (37.2) |
Cmax, AUCtau, AUC0-last and AUC0-inf are presented as geometric mean (GCV), Tmax as median (range), t1/2, CLss/F and Vss/F as mean (standard deviation).
GCV, geometric coefficient of variation; Cmax, maximum concentration;Tmax, time to reach maximum concentration; AUCtau, area under the plasma concentration-time curveat steady-state (one dose interval); AUC0-last, area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration; AUC0-inf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time; t1/2, elimination half-life; CLss/F, steady state clearance rate of oral administration; Vss/F, apparent volume of distribution; Ctrough, valley concentration; Caverage, steady-state average concentration.