Table 4.
Statistical analysis of the effect of ensitrelvir on the pharmacokinetics of midazolam following single-dose administration of midazolam (2 mg) alone and when co-administered with ensitrelvir (375/125 mg)a
| Parameters | Midazolam alone | Midazolam with ensitrelvir | Midazolam with ensitrelvir/midazolam alone | ||
|---|---|---|---|---|---|
| N | GLS mean (Day − 2) | N | GLS mean (Day 5) | GLS mean ratio (90% CI) (Day 5/Day − 2) | |
| Cmax (ng/mL) | 14 | 12.6 | 14 | 35.2 | 2.8012 (2.3798–3.2971) |
| AUC0–last (ng·h/mL) | 14 | 23.35 | 14 | 161.1 | 6.9011 (6.2722–7.5931) |
| AUC0–inf (ng·h/mL) | 14 | 24.08 | 14 | 163.0 | 6.7685 (6.1572–7.4404) |
| λz (1/h) | 14 | 0.2139 | 14 | 0.0940 | 0.4396 (0.3936–0.4909) |
| t1/2,z (h) | 14 | 3.24 | 14 | 7.37 | 2.2750 (2.0373–2.5406) |
| MRT (h) | 14 | 3.18 | 14 | 8.44 | 2.6506 (2.4623–2.8532) |
AUC0–last area under the concentration-time curve to the last measurable concentration, AUC0–inf area under the concentration-time curve extrapolated to infinity, CI confidence interval, Cmax maximum plasma concentration, GLS geometric least square, MRT mean residence time, N number of participants, λz terminal elimination rate constant, t1/2z terminal elimination half-life
a375/125 mg, multiple once-daily doses with 375 mg as the loading dose on Day 1 and 125 mg as the maintenance dose on Days 2–5