Table 6.
Statistical summary of food-effect comparisons
| Molecule and pharmacokinetic parameter | Adjusted geometric means | Ratio (test/reference) | 90 % CI for ratio | |
|---|---|---|---|---|
| Fed (test) | Fasted (reference) | |||
| Enzalutamide | ||||
| N, n | 30, 30 | 27, 27 | – | – |
| AUClast, µg·h/mL | 269 | 270 | 1.00 | 0.88–1.13 |
| AUC∞, µg·h/mL | 276 | 279 | 0.99 | 0.87–1.12 |
| C max, µg/mL | 3.61 | 5.13 | 0.70 | 0.63–0.79 |
| N-desmethyl enzalutamide | ||||
| N, n | 30, 30 | 27, 25 | – | – |
| AUClast, µg·h/mL | 386 | 355 | 1.09 | 0.98–1.21 |
| AUC∞, µg·h/mL | 410 | 379 | 1.08 | 0.96–1.21 |
| C max, µg/mL | 0.81 | 0.76 | 1.06 | 0.95–1.18 |
AUC ∞ area under the plasma concentration–time curve from time zero to infinity, AUC last area under the plasma concentration–time curve from time zero to the last quantifiable concentration, CI confidence interval, C max maximum plasma concentration, N number of subjects for whom AUClast and C max were calculated, n number of subjects for whom AUC∞ was determined