Table 2.

Statistical analysis of the effect of multiple-dose administration of ensitrelvir on the pharmacokinetics of dexamethasone following single-dose administration of dexamethasone (1 mg) alone, when co-administered with ensitrelvir (750/250 mg)^a on Day 5, and then alone on Days 9 and 14

Parameters	Dexamethasone alone (Day − 2)		Dexamethasone with ensitrelvir (Day 5)		5th day after the last ensitrelvir dose (Day 9)		10th day after the last ensitrelvir dose (Day 14)		Dexamethasone with ensitrelvir/dexamethasone alone (Day 5/Day − 2)	5th day after the last ensitrelvir dose/dexamethasone alone (Day 9/Day − 2)	10th day after the last ensitrelvir dose/dexamethasone alone (Day 14/Day − 2)
	N	GLS mean	N	GLS mean	N	GLS mean	N	GLS mean	GLS mean ratio (90% CI)	GLS mean ratio (90% CI)	GLS mean ratio (90% CI)
Cmax (ng/mL)	14	11.4	14	16.9	14	14.2	14	13.4	1.4737 (1.3037–1.6660)	1.2376 (1.0948–1.3991)	1.1725 (1.0372–1.3255)
AUC0–last (ng·h/mL)	14	45.21	14	143.9	14	110.7	14	70.56	3.1840 (2.9607–3.4240)	2.4480 (2.2764–2.6326)	1.5608 (1.4514–1.6785)
AUC0–inf (ng·h/mL)	13	51.73	11	179.3	14	123.0	11	81.70	3.4666 (3.2318–3.7184)	2.3769 (2.2263–2.5377)	1.5792 (1.4704–1.6960)
λz (1/h)	14	0.1716	14	0.0738	14	0.1000	14	0.1289	0.4304 (0.4105–0.4512)	0.5830 (0.5561–0.6113)	0.7514 (0.7166–0.7878)
t1/2,z (h)	14	4.04	14	9.39	14	6.93	14	5.38	2.3235 (2.2161–2.4361)	1.7152 (1.6360–1.7984)	1.3309 (1.2694–1.3954)
MRT (h)	13	5.80	11	13.9	14	10.4	11	7.72	2.4006 (2.2526–2.5584)	1.7949 (1.6913–1.9048)	1.3298 (1.2465–1.4187)

AUC_0-last area under the concentration-time curve to the last measurable concentration, AUC_0-inf area under the concentration-time curve extrapolated to infinity, CI confidence interval, C_max maximum plasma concentration, GLS geometric least square, MRT mean residence time, N number of participants, λ_z terminal elimination rate constant, t_1/2z terminal elimination half-life

^a750/250 mg, multiple once-daily doses with 750 mg as the loading dose on Day 1 and 250 mg as the maintenance dose on Days 2–5