Table 2.
Parameter | Fasted (Reference) (n = 15) | Fed (Test) (n = 15) | Least‐Squares Geometric Mean Ratio (90%CI) (Test/Reference) |
---|---|---|---|
Median Tmax, hours (range) | 1.02 (0.48‐4.0) | 4.0 (1.93‐8.03) | |
Geometric mean Cmax, ng/mL (%CV) | 77.0 (57) | 22.8 (54) | 0.31 (0.21‐0.45) |
Geometric mean AUC0‐216, h · ng/mL (%CV) | 1470 (50) | 999 (79) | 0.72 (0.58‐0.89) |
Abbreviations: AUC0‐216, area under the plasma concentration‐time curve from 0 to 216 hours postdose; CI, confidence interval; Cmax, maximum observed plasma concentration; PK, pharmacokinetic; Tmax, first time of Cmax.