TABLE 4.
Food effects on pharmacokinetic parameters
| Parameter | 30‐mg ASP0367 EP fed | 30‐mg ASP0367 EP fasted | Mean ratio (%) | 90% CI (%) | ||
|---|---|---|---|---|---|---|
| n | Geometric LS mean | n | Geometric LS mean | |||
| AUCinf (h∙ng/mL) | 5 | 295.60 | 5 | 298.84 | 98.92 | 61.38‐159.42 |
| AUClast (h∙ng/mL) | 8 | 302.95 | 6 | 323.31 | 98.71 | 64.62‐135.89 |
| Cmax (ng/mL) | 8 | 50.43 | 6 | 68.87 | 73.22 | 37.65‐142.44 |
Note: Pharmacokinetic analysis set; assessment is based on an analysis of variance performed on natural logarithmic‐transformed parameters with food condition as a fixed effect.
Abbreviations: AUCinf, area under the concentration‐time curve from time zero to infinity; AUClast, area under the concentration‐time curve from time 0 to the time of last quantifiable concentration; CI, confidence interval; Cmax, maximum concentration; EP, extemporaneously prepared; LS, least squares.