Parameter |
SPL026 9 mga |
|
|
|
(n=5) |
SPL026 12 mga (n=6) |
SPL026
17 mga,b (n=5) |
SPL026 21.5
mga (n=6) |
|
Cmax, ng/mL |
|
|
|
|
Mean (SD)
|
20.8 (12.9)
|
30.6 (18.1)
|
72.1 (47.1)
|
62.7 (25.8)
|
Range
|
5.0–34.9
|
12.7–62.3
|
16.2–126.0
|
29.0–107.0
|
CV (%)
|
0.62
|
0.59
|
0.65
|
0.41
|
Tmax, min |
|
|
|
|
Median (range)
|
9.6 (7.0–11.0)
|
10.5 (6.0–11.2)
|
9.8 (9.7–11.3)
|
9.7 (9.7–11.0)
|
AUClast, ng.min/mL |
|
|
|
|
Mean (SD)
|
349 (253)
|
451 (229)
|
842 (453)
|
835 (231)
|
Range
|
71–705
|
245–755
|
204–1298
|
477–1052
|
CV (%)
|
0.72
|
0.51
|
0.54
|
0.28
|
AUCinf, ng.min/mL |
|
|
|
|
Mean (SD)
|
352 (252)
|
455 (229)
|
-
|
837 (231)
|
Range
|
75–707
|
249–763
|
-
|
478–1054
|
CV (%)
|
0.72
|
0.50
|
-
|
0.28
|
t1/2, min |
|
|
|
|
Mean (SD)
|
12.1 (4.7)
|
9.5 (4.0)
|
-
|
12.1 (5.2)
|
Range
|
5.8–18.3
|
6.0–17.0
|
-
|
6.3–20.3
|
CV (%)
|
0.39
|
0.42
|
-
|
0.43
|
CL, L/min |
|
|
|
|
Mean (SD)
|
46.0 (43.6)
|
32.4 (14.6)
|
-
|
27.9 (9.7)
|
Range
|
12.7–120.0
|
15.7–48.2
|
-
|
20.4–45.0
|
CV (%)
|
0.95
|
0.45
|
-
|
0.35
|
Vz, L |
|
|
|
|
Mean (SD)
|
611 (308)
|
425 (214)
|
-
|
456 (157)
|
Range
|
241–996
|
172–683
|
-
|
218–653
|
CV (%)
|
0.50
|
0.50
|
-
|
0.34
|
Vss, L |
|
|
|
|
Mean (SD)
|
551 (346)
|
375 (173)
|
-
|
400 (149)
|
Range
|
246–1094
|
157–587
|
-
|
215–673
|
CV (%)
|
0.63
|
0.46
|
-
|
0.37
|
MRTinf, min |
|
|
|
|
Mean (SD)
|
14.6 (4.1)
|
12.4 (5.6)
|
-
|
15.0 (5.0)
|
Range
|
9.1–19.3
|
8.6–23.3
|
-
|
8.4–20.1
|
CV (%)
|
0.28
|
0.45
|
-
|
0.33
|