Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

This publication evaluates the pharmacokinetics, bioequivalence, and safety of propafenone hydrochloride tablets under fasting conditions in healthy Chinese subjects. Using a fully replicated, four-period crossover design in 36 subjects, plasma concentrations of propafenone and its active metabolite 5-hydroxypropafenone were measured by LC-MS/MS, with pharmacokinetic parameters derived by non-compartmental analysis in Phoenix WinNonlin. Because the reference formulation exhibited high within-subject variability, bioequivalence was assessed using reference-scaled average bioequivalence, and the geometric mean ratios for Cmax, AUC0-t, and AUC0-inf of propafenone all fell within the 80-125% acceptance range. The results demonstrate that the test and reference formulations met bioequivalence criteria under fasting, single-dose conditions.