Table 2.
Subject | t1/2 (days) | tmax* (h) | Cmax (µm) | AUC† (µm h) |
---|---|---|---|---|
Single dose | ||||
1 | 12.0 | 24.0 | 6.91 | 3130 |
2 | 13.3 | 48.0 | 6.76 | 4060 |
3 | 10.3 | 1.00 | 4.75 | 1980 |
4 | 8.83 | 1.00 | 5.98 | 2470 |
5 | 8.83 | 24.1 | 4.72 | 1590 |
6 | 14.3 | 24.0 | 6.57 | 3850 |
Mean | 11.3 | 24.0 | 5.95 | 2850 |
%CV | 20.4 | 1.00–48.0 | 16.7 | 35.1 |
Multiple dose | ||||
13 | 8.88 | 4.00 | 19.2 | 396 |
14 | 13.6 | 4.00 | 14.9 | 332 |
15 | 11.2 | 10.0 | 19.3 | 441 |
16 | 6.46 | 2.00 | 17.7 | 399 |
17 | 8.92 | 1.00 | 17.3 | 344 |
18 | 10.4 | 4.00 | 10.3 | 225 |
Mean | 9.92 | 4.00 | 16.4 | 356 |
%CV | 24.5 | 1.00–10.0 | 20.7 | 21.3 |
tmax summary statistics reported as median and range.
AUC is defined as the AUC (0,∞) for single dose group and AUC (0,24) on day 7 for multiple dose group. t1/2, terminal phase half-life; tmax, time to maximum observed plasma concentration; Cmax, maximum observed plasma concentration; AUC, area under the plasma concentration–time curve.