Table 3.
Comparison of the predicted and observed PK parameters of oral midazolam and budesonide based on in active CD population with reduced HSA
| 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) | 2.4 | 14 ± 6.38 | 0.2 | AUC0–∞ (nmol*h/L) | 61.6 | 114 (81.4–159.5) | 0.54 |
| Cmax (nM) | 1.45 | 8.4 ± 5.13 | 0.2 | Cmax (nM) | 7.8 | 14.3 (6–13.7) | 0.55 |
| Tmax (h) | 0.37 | 0.53 ± 1.3 | 0.7 | Tmax (h) | 4.84 | 6 (3–8) | 0.81 |
| F % | 27 | 31 ± 22 | 0.9 | F % | 14 | 20.5 (8.8–15) | 0.7 |
AUC area under the curve, CD Crohn’s disease, CI confidence interval, Cmax maximum drug concentration, HSA human serum albumin, PK pharmacokinetics, Tmax time to reach Cmax, F oral bioavailability