Table 2.
Parameter | Fed | Fasted | Adjusted GMR, % (90% CI) [fed/fasted] |
---|---|---|---|
Patients, n | 15 | 15 | – |
t max a | 4 [1–24] | 3 [1–6] | – |
, nM·h | 30,992c | 33,518 | 92.46 (74.24–115.16) |
AUC0–∞,obs, nM·h | 39,219 | 39,949 | 98.17 (78.53–122.74) |
Cmax, nM | 1636 | 1873 | 87.34 (71.04–107.38) |
t½, hb | 18.0 (16.1)c | 18.0 (22.6) | – |
Unless otherwise specified, data are adjusted geometric mean
AUC0–∞,obs observed area under the plasma concentration–time curve extrapolated from time zero to infinity, area under the plasma concentration–time curve from time zero to the last quantifiable concentration at tz, Cmax maximum plasma concentration, t½ terminal half-life, tmax time to maximum plasma concentration, – not calculated
aMedian [range]
bGeometric mean [coefficient of variation (%)]
cn = 14