Table 2.
PK parameter | N | LSM | Geometric mean | Ratioa (%) | 90% CIb | ANOVA p-valuec | ||
---|---|---|---|---|---|---|---|---|
Fed | Fasted | Fed | Fasted | |||||
AUC0−t (ng × min/mL) | 20 | 9.53 | 9.65 | 13,772.6 | 15,521.3 | 88.7 | (82.27, 95.8) | 0.01 |
AUC0−∞ (ng × min/mL) | 20 | 9.55 | 9.66 | 14,000.7 | 15,767.0 | 88.8 | (82.2, 96.0) | 0.02 |
Cmax (ng/mL) | 20 | 3.36 | 3.61 | 28.9 | 37.1 | 77.8 | (72.3, 83.6) | < 0.0001 |
ANOVA analysis of variance; AUC0−t area-under-the-curve; AUC0−∞ AUC0−t extrapolated to infinity; Cmax maximum plasma concentration; CI confidence interval; LSM least square mean; mL milliliters; min minutes; N number of subjects; ng nanograms; PK pharmacokinetic; SD standard deviation
aRatio = 100% × geometric mean (fed) / geometric mean (fasted)
b90% Confidence interval on the ratio of fed and fasted
cp-value for the difference in the treatment estimates. Significant difference was defined as p-value < 0.05