Table III.
Part III, healthy adults | Part IV, elderly subjects | ||||||
---|---|---|---|---|---|---|---|
Pharmacokinetic parameters | Units | 10 mg BID (N = 9) | 40 mg BID (N = 9) | 100 mg BID (N = 9) | 160 mg BID (N = 9) | 40 mg BID (N = 9) | 160 mg BID (N = 9) |
Day 7 | Day 14 | Day 7 | |||||
C max | ng/mL | 598 ± 204 | 2,070 ± 242 | 5,140 ± 968 | 7,370 ± 1,650 | 2,270 ± 713 | 8,620 ± 1,790 |
T max | h | 2.56 ± 0.53 | 2.44 ± 0.53 | 2.83 ± 0.50 | 2.17 ± 0.66 | 2.25 ± 0.65 | 1.88 ± 0.58 |
C trough | ng/mL | 151 ± 80 | 494 ± 210 | 1,080 ± 502 | 1,240 ± 520 | 693 ± 606 | 1,610 ± 608 |
AUC0–12 a | μg·h/mL | 3.97 ± 1.5 | 13.5 ± 3.1 | 30.7 ± 8.3 | 42.5 ± 11.8 | 15.9 ± 8.2 | 52.0 ± 13.6 |
AUC12–24 a | μg·h/mL | 3.45 ± 1.40 | 11.9 ± 2.8 | 26.6 ± 7.5 | 39.7 ± 9.7 | 14.7 ± 7.7 | 46.7 ± 10.8 |
CL/F | L/h | 2.82 ± 0.98 | 3.10 ± 0.64 | 3.46 ± 0.86 | 4.04 ± 1.17 | 2.94 ± 0.95 | 3.28 ± 0.91 |
t ½ b | h | 5.52 ± 1.2 | 5.80 ± 1.7 | 6.56 ± 1.5 | 6.44 ± 2.24 | 7.40 ± 2.32 | 8.77 ± 2.91 |
AUC R ac c | 1.36 [1.13–1.75] | 1.12 [1.07–1.45] | 1.16 [1.02–1.47] | 1.23 [1.08–1.40] | 1.25 [1.10–1.60] | 1.13 [0.97–1.29] |
Mean ± standard deviation reported
aAUC value on study day 7
bHarmonic mean and pseudo standard deviation
cMedian (range)