Table 2.

Comparison of the predicted and observed PK parameters of oral midazolam and budesonide in inactive CD populations

Parameter	Midazolam oral solution, fasted			Parameter	Budesonide controlled release, fed
	Predicted	Observed Mean ± SD	Predicted/Observed		Predicted	Observed Mean (95% CI)	Predicted/Observed
AUC0–∞ (nM*h)	2.1	14 ± 6.38	0.15	AUC0–∞ (nM*h)	46.7	114 (81.4–159.5)	0.41
Cmax (nM)	1.3	8.4 ± 5.13	0.16	Cmax (nM)	6.22	14.3 (6–13.7)	0.43
Tmax (h)	0.39	0.53 ± 1.3	0.5	Tmax (h)	4.8	6 (3–8)	0.8
F %	22	31 ± 22	0.8	F %	10	20.5 (8.8–15)	0.5

AUC area under the curve, CD Crohn’s disease, CI confidence interval, C_max maximum drug concentration, PK pharmacokinetics, T_max time to reach C_max, F oral bioavailability