Table 1.
Parameter | Study phase | Geometric mean | 95% confidence interval | |
---|---|---|---|---|
Lower | Upper | |||
In vivo Midazolam AUC | Baseline | 8.2 | 4.9 | 11.5 |
Induced | 2.2 | 1.5 | 2.9 | |
In vivo Midazolam C max | Baseline | 4.1 | 3.2 | 5.0 |
Induced | 0.9 | 0.6 | 1.2 | |
Exosome CYP3A4 protein expression | Baseline | 0.24 | 0.20 | 0.28 |
Induced | 0.42 | 0.21 | 0.65 | |
Exosome CYP3A4 mRNA expression | Baseline | 6.0 | 1.1 | 32.7 |
Induced | 48.3 | 11.3 | 104 | |
Ex Vivo CYP3A4 activity | Baseline | 25.8 | 22.9 | 30.5 |
Induced | 38.9 | 27.7 | 68.1 |
Area under the plasma–concentration time curve (AUC): μg l–1 h; maximal concentration (Cmax): μg l–1; Exosome CYP3A4 protein expression; ng ml–1 concentrated exosome sample, exosome CYP3A4 mRNA expression (x10–11); 2‐ΔΔCt, Ex vivo CYP3A4 activity (rate of 1‐hydroxy midazolam formation at 50 μmol l–1 midazolam); pmol min–1 mg–1