Table 4 Summary of PK parameters.
PK Parameter (Unit) | Statistics | China | New Zealand | ||||
|---|---|---|---|---|---|---|---|
0.12 mg/kg | 0.25 mg/kg | 0.40 mg/kg | 0.12 mg/kg | 0.25 mg/kg | 0.40 mg/kg | ||
(N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | ||
Cmax (mg/L) | Mean (SD) | 2.208 (0.4985) | 5.142 (0.2922) | 9.200 (1.3049) | 2.8135 (0.5216) | 6.5245 (0.9994) | 8.5279 (4.3509) |
Tmax (h) | Median | 0.333 | 0.333 | 0.583 | 0.4583 | 0.3333 | 0.5833 |
AUC0-t (h*mg/L) | Mean (SD) | 28.405 (29.6554) | 43.114 (21.7201) | 170.261 (176.5502) | 45.2515 (47.9476) | 101.9423 (113.8636) | 56.4783 (29.7341) |
AUC0-∞ (h*mg/L) | Mean (SD) | 14.426 (9.9368) | 28.566 (12.7335) | 310.104 (368.8912) | 27.3255 (26.0003) | 19.4597 (1.9367) | 55.8364 (20.6792) |
λz (1/h) | Mean (SD) | 6.260 (6.1106) | 4.862 (2.5096) | 81.648 (107.5154) | 0.1144 (0.1389) | 0.1571 (0.1649) | 0.1155 (0.1445) |
t1/2 (h) | Mean (SD) | 6.260 (6.1106) | 4.862 (2.5096) | 81.648 (107.5154) | 11.3978 (13.3972) | 2.2629 (0.1476) | 8.4130 (8.0801) |
MRT0-∞ (h) | Mean (SD) | 7.956 (7.8214) | 5.714 (2.7533) | 196.187 (268.7298) | 14.7852 (17.5298) | 2.9775 (0.2253) | 8.9927 (7.8506) |
CL (L/h/kg) | Mean (SD) | 0.011 (0.0075) | 0.011 (0.0063) | 0.004 (0.0052) | 0.0079 (0.0054) | 0.0129 (0.0014) | 0.0079 (0.0027) |
Vz (L/kg) | Mean (SD) | 0.065 (0.0283) | 0.059 (0.0076) | 0.113 (0.0661) | 0.0592 (0.0197) | 0.0423 (0.0054) | 0.0836 (0.0710) |
