TABLE 5.
Statistical analysis of food effect on the PK of SPR719 following single oral 1,000 mg doses of SPR720a
| Parameter | Geometric LS mean |
Geometric LS mean ratio (%) 90% CI | Within-subject CV (%) | |
|---|---|---|---|---|
| 1,000 mg, fasted (n = 6) | 1,000 mg, fed (n = 6) | |||
| Cmax (ng/ml) | 4,730 | 4,000 | 84.6 (69.9–102.4) | 16.6 |
| AUClast (h ⋅ ng/ml) | 56,500 | 45,100 | 79.9 (68.5–93.0) | 13.2 |
| AUCinf (h ⋅ ng/ml) | 56,800 | 45,200 | 79.6 (68.3–92.8) | 13.2 |
a
Results were obtained using a fixed-effects ANOVA with fixed effects of treatment and subject. AUCinf, area under the concentration-time curve (AUC) extrapolated to infinity; AUClast, AUC from time of dosing to time of the last measurable concentration; CI, confidence interval; Cmax, maximum plasma concentration; CV, coefficient of variation; LS mean, least-squares mean.