Results from in vitro and in vivo studies evaluating the bioavailability, effects of food, and administration as crushed tablet suspension on vericiguat pharmacokinetics

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Table 5 Assessments of food and food type: point estimates (LS means) and two-sided 90% CIs of PK parameters after administration of vericiguat

Comparison (test vs reference)	Parameter (unit)	n	CV (%)	Ratio (%)	90% CI
Effects of food
5 mg intact tablet (with food)/5 mg intact tablet (fasted)	AUC, µg*h/L	15	15.69	118.76	107.87–130.74
5 mg intact tablet (with food)/5 mg intact tablet (fasted)	C_max, µg/L	15	27.68	109.23	92.38–129.15
10 mg intact tablet (with food)/10 mg intact tablet (fasted)	AUC, µg*h/L	29	28.02	143.79	127.08–162.69
	C_max, µg/L	29	38.91	140.67	118.83–166.52
Effects of food type: low-fat, low-calorie or high-fat, high-calorie meal
10 mg intact tablet (low-fat, low-calorie meal)/10 mg intact tablet (high-fat, high-calorie meal)	AUC/D, h/L	29	15.06	108.26	101.43–115.56
	C_max/D, /L	29	22.96	118.86	107.69–131.18

Geometric CV indicating intra-individual variability
ANOVA Analysis of variance, AUC Area under curve, AUC/D Dose-normalized area under the curve, CI Confidence interval, C_max Maximum plasma concentration, C_max/D Dose-normalized maximum plasma concentration, CV Coefficient of variation, IR Immediate release, LS Least squares, PK Pharmacokinetic
Ratio: LS means for the respective treatment ratio calculated by ANOVA