|
Part 1 |
Part 1 |
Part 1 |
Part 1 |
Part 1 |
Part 2 |
Part 2 |
|
LSF 5 mg |
ASD tablet 5 mg |
ASD tablet 5
mg |
ASD tablet 5 mg |
ASD tablet 5 mg |
ASD
tablet 10 mg |
ASD tablet 10 mg |
|
Fasting
N=11
|
GR fasting
N=11
|
GS fasting
N=10
|
GR fed
N=12
|
GS fed
N=11
|
GR fasting
N=12
|
GS fasting
N=10
|
AUClast
(hng/mL)
|
1160
(43.7)
|
856
(19.2)
|
921
(24.0)
|
677
(32.3)
|
735
(35.0)
|
1665
(32.2)
|
1990
(29.9)
|
AUC0-7d
(hng/mL)
|
1215
(37.2)
|
852
(19.1)
|
931
(23.3)
|
674
32.1)
|
733
(34.9)
|
1609
(35.9)
|
1943
(26.5)
|
AUC0-7d/D
([hng/mL]/mg)
|
243
37.2)
|
170
(19.1)
|
186
(23.3)
|
135
(32.1)
|
147
34.9)
|
161
(35.9)
|
194
(26.5)
|
Cmax
(ng/mL)
|
88.5
(20.1)
|
41.9
(20.0)
|
54.2
(35.3)
|
27.1
(26.8)
|
36.2
(39.8)
|
71.7
(28.5)
|
135
(35.3)
|
Cmax/D
([ng/mL]/mg)
|
17.7
(20.1)
|
8.38
(20.0)
|
10.8
(35.3)
|
5.41
(26.8)
|
7.24
(39.8)
|
7.17
(28.5)
|
13.5
(35.3)
|
tmax
(h)
|
1.00
(0.50–1.50)
|
4.00
(2.50–6.00)
|
1.50
(1.00–2.52)
|
5.01
(1.50–8.00)
|
3.00
(2.00–6.00)
|
3.50
(2.50–6.00)
|
1.50
(1.00–2.50)
|
Terminal t½
(h)
|
220
(87.1)
|
234
(71.2)
|
253
(53.0)
|
235
(75.7)
|
208
(63.9)
|
238
(100.6)
|
233
(90.2)
|
t ½ 0-24*
(h)
|
11.0
(31.6)
|
10.0
(20.6)
|
11.0
(29.1)
|
10.5
(22.9)
|
11.1
(31.7)
|
9.23
(21.6)
|
10.7
(17.1)
|
λz
(1/h)
|
0.00315
(87.1)
|
0.00296
(71.2)
|
0.00274
(53.0)
|
0.00295
(75.7)
|
0.00334
(63.9)
|
0.00291
(100.6)
|
0.00297
(90.2)
|
MRTlast
(h)
|
48.1
(45.1)
|
55.9
(7.4)
|
54.2
(15.4)
|
60.6
(5.4)
|
58.5
(9.3)
|
60.2
(21.1)
|
57.9
(13.8)
|