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

Table 2 Study 2: AUC and C_max 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):

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)
	C_max	μ/L	18.77	88	(80– 96)
Crushed tablet suspended in water/whole tablet fasted	AUC	μ*h/L	16.76	103	(95–112)
	C_max	μ/L	18.77	117	(107–128)
Whole tablet fed (continental breakfast)/whole tablet fasted	AUC	μ*h/L	16.76	96	(89–104)
	C_max	μ/L	18.77	84	(77–92)

AUC, area under the concentration versus time curve; C_max, maximum drug concentration in plasma
CI, confidence interval; CV, coefficient of variation; IR, immediate release

ISSN: 2050-6511