Bioequivalence Study of Capsules versus Film Tablets Containing Rivaroxaban in Healthy Caucasian Subjects under Fasting and Fed Conditions

This publication reports two single-dose, randomized crossover bioequivalence studies comparing capsule and film tablet formulations of rivaroxaban (10 mg under fasting conditions and 20 mg under fed conditions) in healthy Caucasian subjects. Plasma rivaroxaban was measured by LC-MS/MS and pharmacokinetic parameters calculated by non-compartmental analysis using Phoenix WinNonlin. The 90% confidence intervals for all pharmacokinetic parameters fell within the standard 80-125% bioequivalence range for both strengths, with no clinically relevant differences in tolerability or safety between formulations. The results demonstrate that the rivaroxaban capsule and film tablet formulations are bioequivalent in healthy Caucasian subjects.