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. 2021 Apr 8;38(6):2936–2952. doi: 10.1007/s12325-021-01707-9

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