Table 5.
Relative bioavailability of the M3 metabolite with sprinkle vs capsule formulations, and with sprinkle formulation in fed vs fasted states
| Comparison | Parameter | Geometric LS mean | ||
|---|---|---|---|---|
| Values | Ratio | 90% CI | ||
| Sprinkle vs capsule | Cmax (pg/mL), n = 30 | 129.974 vs 63.566 | 2.045 | 1.615, 2.589 |
| AUC0–t (h·pg/mL), n = 30 | 167.770 vs 116.426 | 1.441 | 1.166, 1.782 | |
| AUC0–∞ (h·pg/mL), n = 8 | 249.646 vs 196.115 | 1.273 | 0.837, 1.937 | |
| Sprinkle, fed vs fasted | Cmax (pg/mL), n = 14 | 48.192 vs 116.815 | 0.413 | 0.339, 0.502 |
| AUC0–t (h·pg/mL), n = 14 | 135.805 vs 152.900 | 0.888 | 0.675, 1.168 | |
AUC area under the concentration–time curve, AUC0–t from hour 0 to the last measurable concentration, AUC0–∞ extrapolated to infinity, CI confidence interval, Cmax maximum observed concentration, LS least squares, M3 lubiprostone metabolite