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Table 2 Study 2: AUC and Cmax ratios of ‘crushed tablet suspended in water or applesauce/whole IR tablet’ (fasted) and ‘whole IR tablet fed/whole IR tablet fasted’ after a single oral dose of riociguat (pharmacokinetic analysis population, n=24):

From: Bioavailability, pharmacokinetics and safety of riociguat given as an oral suspension or crushed tablet with and without food

Ratio Parameter Unit CV Estimated ratio (%) 90% CI
Crushed tablet suspended in applesauce/whole tablet fasted AUC μ*h/L 16.76 98 (91–107)
  Cmax μ/L 18.77 88 (80– 96)
Crushed tablet suspended in water/whole tablet fasted AUC μ*h/L 16.76 103 (95–112)
  Cmax μ/L 18.77 117 (107–128)
Whole tablet fed (continental breakfast)/whole tablet fasted AUC μ*h/L 16.76 96 (89–104)
  Cmax μ/L 18.77 84 (77–92)
  1. AUC, area under the concentration versus time curve; Cmax, maximum drug concentration in plasma
  2. CI, confidence interval; CV, coefficient of variation; IR, immediate release