Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets

AAPS Open

Table 2 Numeric predictive check of statistical analysis of pharmacokinetic parameters comparison of statistical analysis of pharmacokinetic parameters derived from empirical Bayesian estimates versus pharmacokinetic parameters from study NCT03802682

PK parameter	Source	n	Geometric means		Applesauce versus whole tablet
PK parameter	Source	n	Whole tablet	Mixed in applesauce	Geometric mean ratio (%)	Lower limit 90% CI	Upper limit 90% CI
C_max (µg/mL)	Study^a	10	1.80	2.30	127.57	113.76	143.05
C_max (µg/mL)	EBE	10	1.54	2.14	138.95	124.60	154.96
AUC_0–168 h	Study^a	10	106	111	105.22	102.88	107.60
AUC_0–168 h	EBE	10	107	111	103.12	100.50	105.80

AUC Area under the concentration–time curve, C_max Maximum plasma concentration, CI Confidence interval, EBE Empirical Bayes estimates, PK Pharmacokinetics
^aRefers to NCT03802682