Dose |
PK parameters |
PK parameters |
Mean (SD) |
Mean (SD) |
P
value |
|
|
|
Male |
Female |
|
|
n |
/ |
5 |
5 |
|
|
Cmax
|
μg/mL |
99.79 (13.47) |
122.77 (17.33) |
0.047* |
|
AUC0-t
|
μg·h /mL |
225.65 (17.19) |
308.53 (58.47) |
0.016* |
2.0 g single-dose |
AUC0-∞
|
μg·h /mL |
231.24 (18.70) |
318.24 (58.86) |
0.014* |
|
T1/2
|
h |
4.91 (1.78) |
5.39 (1.87) |
0.687 |
|
CLz
|
L/h |
8.70 (0.69) |
6.46 (1.19) |
0.007* |
|
Vz
|
L |
60.03 (19.07) |
48.49 (14.02) |
0.297 |
|
n |
|
5 |
5 |
|
|
Cmax
|
μg/mL |
237.15 (27.34) |
224.38 (32.61) |
0.521 |
4.0 g single-dose |
AUC0-t
|
μg·h /mL |
503.98 (36.19) |
545.01 (97.91) |
0.405 |
|
AUC0-∞
|
μg·h /mL |
511.87 (43.19) |
560.2 (102.01) |
0.357 |
|
T1/2
|
h |
4.58 (1.57) |
5.83 (1.57) |
0.246 |
|
CLz
|
L/h |
7.86 (0.65) |
7.38 (1.64) |
0.560 |
|
Vz
|
L |
51.14 (13.59) |
62.70 (23.64) |
0.371 |
|
n |
|
5 |
5 |
|
|
Cmax
|
μg/mL |
339.46 (40.13) |
365.88 (45.85) |
0.361 |
8.0 g single-dose |
AUC0-t
|
μg·h /mL |
776.09 (103.22) |
869.27 (65.67) |
0.127 |
|
AUC0-∞
|
μg·h /mL |
784.77 (102.82) |
879.37 (70.45) |
0.128 |
|
T1/2
|
h |
4.25 (1.37) |
4.30 (1.23) |
0.954 |
|
CLz
|
L/h |
10.33 (1.27) |
9.14 (0.74) |
0.110 |
|
Vz
|
L |
63.73 (24.74) |
56.26 (14.93) |
0.579 |
|
n |
|
5 |
5 |
|
|
Cmax
|
μg/mL |
172.47 (24.78) |
190.10 (22.54) |
0.273 |
4.0 g multiple-dose |
AUC0-t
|
μg·h /mL |
509.60 (83.31) |
593.53 (73.70) |
0.130 |
Day 1 |
AUC0-∞
|
μg·h /mL |
528.57 (92.59) |
596.86
(74.32) |
0.234 |
|
T1/2
|
h |
5.92 (2.10) |
3.44 (0.14) |
0.058 |
|
CLz
|
L/h |
7.75 (1.32) |
6.78 (0.84) |
0.202 |
|
Vz
|
L |
64.86 (19.76) |
33.70 (3.97) |
0.023* |
|
n |
|
5 |
5 |
|
|
Css-max
|
μg/mL |
174.30 (23.04) |
198.33 (29.98) |
0.193 |
4.0 g multiple-dose |
AUCss
|
μg·h /mL |
519.79 (40.52) |
635.36 (93.12) |
0.034* |
Day 7 |
AUC0-∞
|
μg·h /mL |
539.18 (43.74) |
662.25
(105.11) |
0.042* |
|
t1/2
|
h |
5.80 (2.43) |
6.28 (1.35) |
0.708 |
|
CLss
|
L/h |
7.46 (0.60) |
6.18 (1.07) |
0.048* |
|
Vss
|
L |
61.94 (23.82) |
54.62 (8.30) |
0.545 |