Table 3.
Statistical analysis of the effect of alcohol on systemic exposure to remimazolam and CNS7054
| Test vs. reference | PK parameter | LS geometric mean ratio (90% CI) | |
|---|---|---|---|
| Remimazolam | CNS7054 | ||
| Remimazolam 360 mg + 5% v/v alcohol vs. remimazolam 360 mg alone | Cmax (ng/mL) | 1.195 (0.983–1.452) | 1.019 (0.913–1.138) |
| AUC0–last (h·ng/mL) | 1.127 (1.039–1.223) | 1.005 (0.949–1.065) | |
| AUC0–inf (h·ng/mL) | 1.116 (1.030–1.209) | 1.019 (0.954–1.088) | |
| Remimazolam 360 mg + 15% v/v alcohol vs. remimazolam 360 mg alone | Cmax (ng/mL) | 1.572 (1.294–1.911) | 1.035 (0.927–1.156) |
| AUC0–last (h·ng/mL) | 1.617 (1.490–1.754) | 1.066 (1.007–1.130) | |
| AUC0–inf (h·ng/mL) | 1.593 (1.467–1.730) | 1.066 (0.998–1.138) | |
| Remimazolam 360 mg + 40% v/v alcohol vs. remimazolam 360 mg alone | Cmax (ng/mL) | 1.866 (1.500–2.323) | 1.058 (0.936–1.197) |
| AUC0–last (h·ng/mL) | 2.073 (1.892–2.272) | 1.195 (1.120–1.275) | |
| AUC0–inf (h·ng/mL) | 1.995 (1.823–2.183) | 1.225 (1.138–1.319) | |
AUC area under the curve, CI confidence interval, Cmax maximum observed plasma concentration, LS least squares, PK pharmacokinetic