Parameter |
Dosing Condition |
Fasting |
Fed |
Low-fat meal* |
Medium-fat meal |
High-fat meal |
Cmax (ng/ml) |
433 ± 111 (26)
[419] |
471 ± 117 (25)
[455] |
463 ± 118 (26)
[447] |
500 ± 121 (24)
[483] |
tmax (h)† |
6.00 (4.00, 24.00) |
10.00 (4.00, 16.00) |
8.00 (4.00, 16.00) |
8.00 (6.00, 12.00) |
t½ (h) |
10.73 ± 1.69 (16)
[10.60]‡ |
10.64 ± 1.74 (16)
[10.49] |
11.04 ± 4.68 (42)
[10.53] |
10.39 ± 2.13 (21)
[10.18] |
AUCT (ng*h/ml) |
11019 ± 2863 (26)
[10541]‡ |
10797 ± 2496 (23)
[10434] |
11200 ± 2346 (21)
[10907] |
10507 ± 2609 (25)
[10096] |
AUC (ng*h/ml) |
11245 ± 2936 (26)
[10759]‡ |
10995 ± 2558 (23)
[10624] |
11496 ± 2562 (22)
[11170] |
10683 ± 2703 (25)
[10259] |
Cl/F (L/h) |
19.90 ± 9.91 (50)
[18.59]‡ |
19.81 ± 8.32 (42)
[18.83] |
18.6 ± 6.38 (34)
[17.90] |
20.68 ± 9.18 (44)
[19.50] |
Cl/F (L/h/kg) |
0.27 ± 0.14 (50)
[0.25]‡ |
0.27 ± 0.10 (39)
[0.25] |
0.26 ± 0.08 (31)
[0.25] |
0.28 ± 0.12 (43)
[0.26] |