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Table 6 Effects of crushing tablets on PK parameters of vericiguat: single oral dose administration of 10 mg intact or crushed tablet

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

Comparison (test vs reference)

Parameter (unit)

n

CV (%)

Ratio (%)

90% CI

Comparative bioavailability study

 10 mg crushed tablet (high-fat, high-calorie meal)/10 mg intact tablet (high-fat, high-calorie meal)

AUC/D, h/L

29

15.06

101.10

94.72–107.91

Cmax/D, /L

29

22.96

102.25

92.65–112.86

  1. Geometric CV indicating intra-individual variability
  2. AUC/D Dose-normalized area under the curve, CI Confidence interval, Cmax Maximum plasma concentration, Cmax/D Dose-normalized maximum plasma concentration, CV Coefficient of variation, LS Least squares, PK Pharmacokinetic
  3. Ratio: LS means for the respective treatment ratio calculated by ANOVA
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