Table 4.

Summary of AUC_last (ng·min/L) and C_max (ng/mL) ratios of fexuprazan in the two clinical trials and simulations.

Dose	AUCobs	AUCpred	AUCratio	Cmax,obs	Cmax,pred	Cmax ratio
Training set (1st day MAD) 1
20 mg	9020	11,900	1.32	16.3	16.6	1.02
40 mg	23,700	23,900	1.01	40.4	33.2	0.822
80 mg	62,400	48,000	0.770	99.1	66.6	0.672
Validation set (7th day MAD) 1
20 mg/day	16,300	14,900	0.916	20.8	20.2	0.972
40 mg/day	28,300	30,000	1.06	43.2	40.4	0.935
80 mg/day	68,700	60,400	0.880	94.4	81.2	0.861
Validation set (1st dose) 2
40 mg	21,000	29,800	1.42	28.8	33.2	1.15
80 mg	66,300	60,000	0.905	86.4	66.6	0.770
Validation set (8th dose) 2
40 mg/day	28,300	37,500	1.32	35.5	40.4	1.14
80 mg/day	61,800	75,700	1.23	78.9	81.2	1.03

¹ Observed data from the registered clinical trial in healthy volunteers (registered at ClinicalTrials.gov as NCT02757144 [10,22]). The observed value is the average value of the pharmacokinetic parameters obtained from the data of eight people. ² Observed data from the registered clinical trial among Korean, Caucasian, and Japanese (registered at ClinicalTrials.gov as NCT03574415 [1,23]). The observed value is the average value of the pharmacokinetic parameters obtained from the data of 24 people.