Table 4.
Comparison of the predicted and observed PK parameters of oral midazolam and budesonide in active CD populations with normal 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) | 5 | 14 ± 6.38 | 0.36 | AUC0–∞ (nM*h) | 104.6 | 114 (81.4–159.5) | 0.92 |
| Cmax (nM) | 2.31 | 8.4 ± 5.13 | 0.3 | Cmax (nM) | 14.1 | 14.3 (6–13.7) | 0.99 |
| Tmax (h) | 0.45 | 0.53 ± 1.3 | 0.85 | Tmax (h) | 4.75 | 6 (3–8) | 0.8 |
| F % | 34 | 31 ± 22 | 1.1 | F % | 21 | 20.5 (8.8–15) | 1.02 |
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