Parameter |
Treatment Day |
Statistic |
40 mg |
80 mg |
|
|
n/nmiss |
Day 1 and 10:
9/0
|
Day 1: 8/0
Day 10: 7/1
|
AUC0-24h (nmol∙h/L) |
Day 1 |
Mean (SD) |
5580
(1650) |
11500 (2410) |
|
|
Median
(Min, Max)
|
5990
(3170, 8680)
|
1160
(8220, 16400)
|
|
|
Geometric mean |
5360 |
11300 |
|
|
Geometric CV (%) |
31.6 |
20.3 |
AUCss (nmol∙h/L) |
Day 10 |
Mean (SD) |
6000
(1970) |
12200 (3150) |
|
|
Median
(Min, Max)
|
5920
(3690, 9360)
|
11900
(8150, 18200)
|
|
|
Geometric mean |
5730 |
11900 |
|
|
Geometric CV (%) |
32.8 |
25.2 |
Cmax (nmol/L) |
Day 1 |
Mean (SD) |
630 (54.0) |
1490 (410) |
|
|
Median
(Min, Max)
|
630
(559, 729)
|
1370
(1010, 2220)
|
|
|
Geometric mean |
628 |
1440 |
|
|
Geometric CV (%) |
8.54 |
27.1 |
|
Day 10 |
Mean (SD) |
567 (95.7) |
1430 (393) |
|
|
Median
(Min, Max)
|
600
(438, 736)
|
1370
(881, 2150)
|
|
|
Geometric mean |
560 |
1380 |
|
|
Geometric CV (%) |
17.1 |
28.0 |
tmax (h) |
Day 1 |
Median
(Min, Max)
|
2.0
(0.3, 3.0)
|
0.8
(0.3, 2.0)
|
|
Day 10 |
Median
(Min, Max)
|
2.0
(0.7, 8.0)
|
2.0
(0.4, 3.0)
|
t1/2 (h) |
Day 1 |
Mean (SD) |
6.8 (1.3) |
7.1
(1.1) |
|
|
Median
(Min, Max)
|
6.3
(5.4, 9.4)
|
6.7
(5.7, 8.7)
|
|
Day 10 |
Mean (SD) |
7.0 (1.4) |
7.2 (0.6) |
|
|
Median
(Min, Max)
|
6.7
(4.8, 9.5)
|
7.3
(6.1, 8.0)
|
CL/F (L/h) |
Day 1 |
Mean (SD) |
26.0 (9.44) |
23.7
(5.12) |
|
|
Median
(Min, Max)
|
22.2
(13.5, 43.5)
|
23.6
(15.2, 33.3)
|
|
|
Geometric mean |
24.6 |
23.2 |
|
|
Geometric CV (%) |
36.7 |
22.5 |
|
Day 10 |
Mean (SD) |
26.5 (8.1) |
25.0 (6.1) |
|
|
Median
(Min, Max)
|
24.5
(15.5, 39.3)
|
24.4
(15.9, 35.6)
|
|
|
Geometric mean |
25.4 |
24.4 |
|
|
Geometric CV (%) |
32.8 |
25.2 |
Vz/F (L) |
Day 1 |
Mean (SD) |
242 (54.5) |
239
(43.0) |
|
|
Median
(Min, Max)
|
222
(183, 356)
|
229
(180, 301)
|
|
|
Geometric mean |
237 |
236 |
|
|
Geometric CV (%) |
20.9 |
18.2 |
|
Day 10 |
Mean (SD) |
256 (53.3) |
258 (63.4) |
|
|
Median
(Min, Max)
|
232
(190, 349)
|
250
(159, 348)
|
|
|
Geometric mean |
251 |
251 |
|
|
Geometric CV (%) |
20.2 |
26.5 |