Age/sex grouping |
n |
Cmax, ng/mla |
tmax, h |
t1/2, h |
AUC, ng•h/mla |
Cl/F, L/h/kg |
ClR, ml/min |
ClCr, ml/min |
Youngb men |
8 |
|
|
|
|
|
|
|
Mean (SD) |
|
411 (93) |
7.3 (2.1) |
11.8 (4.5) |
9,702 (4,134) |
0.28 (0.11) |
121 (35) |
128 (39) |
CV, % |
|
23 |
29 |
38 |
43 |
39 |
29 |
30 |
Geo. mean |
|
402 |
7.0 |
11.1 |
8,713 |
0.26 |
117 |
122 |
Youngb women |
8 |
|
|
|
|
|
|
|
Mean (SD) |
|
562 (133) |
5.8 (0.7) |
9.2 (0.9) |
10,237 (2,249) |
0.32 (0.5) |
113 (44) |
88 (32) |
CV, % |
|
24 |
12 |
10 |
22 |
14 |
39 |
36 |
Geo. mean |
|
549 |
5.7 |
9.1 |
9,913 |
0.32 |
100 |
80 |
Elderlyc men |
7 |
|
|
|
|
|
|
|
Mean (SD) |
|
450 (61) |
9.7 (2.9) |
11.1 (1.7) |
12,037 (3,284) |
0.23 (0.5) |
105 (26) |
91 (21) |
CV, % |
|
14 |
30 |
15 |
27 |
24 |
25 |
23 |
Geo. mean |
|
446 |
9.3 |
11.0 |
11,425 |
0.22 |
102 |
90 |
Elderlyc women, |
8 |
|
|
|
|
|
|
|
Mean (SD) |
|
566 (140) |
6.3 (1.7) |
11.1 (3.4) |
14,126 (5,342) |
0.24 (0.6) |
102 (29) |
102 (61) |
CV, % |
|
25 |
27 |
30 |
38 |
27 |
28 |
60 |
Geo. mean |
|
551 |
6.0 |
10.7 |
13,065 |
0.23 |
98 |
93 |
Very oldd men |
9 |
|
|
|
|
|
|
|
Mean (SD) |
|
582 (135) |
8.7 (2.6) |
11.7 (1.9) |
14,941 (4,660) |
0.19 (0.4) |
91 (44) |
73 (29) |
CV, % |
|
23 |
31 |
17 |
31 |
21 |
45 |
40 |
Geo. mean |
|
569 |
8.3 |
11.6 |
13,994 |
0.18 |
82 |
64 |
Very oldd women |
8 |
|
|
|
|
|
|
|
Mean (SD) |
|
688 (132) |
8.5 (3.2) |
10.6 (1.3) |
15,851 (4,669) |
0.22 (0.7) |
83 (21) |
82 (24) |
CV, % |
|
19 |
37 |
12 |
30 |
34 |
25 |
30 |
Geo. mean |
|
678 |
7.9 |
10.6 |
14,899 |
0.21 |
81 |
79 |
Two-factor analysis of variance of log-transformed data |
Age |
|
0.001 |
0.060 |
0.433 |
0.001 |
<0.001 |
0.119 |
0.102 |
Sex |
|
<0.001 |
0.011 |
0.091 |
0.288 |
0.096 |
0.555 |
0.611 |
Age/sex |
|
0.633 |
0.200 |
0.543 |
0.934 |
0.713 |
0.870 |
0.125 |
aCmax and AUC were normalized to a common 200-mg dose.
bYoung, 18–45 years.
cElderly, 65–75 years.
dVery old, >75 years.
AUC, total area under plasma concentration-versus-time curve; ClCr, creatinine clearance; Cl/F, apparent oral-dose clearance (dose/AUC); ClR, renal clearance; Cmax, peak
plasma concentration; CV, coefficient of variation; Geo. mean, geometric mean; t1/2, terminal-phase elimination half-life; tmax, time to Cmax. |