Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions

This publication reports a bioequivalence study comparing a generic and an innovator 40-mg lurasidone hydrochloride film-coated tablet formulation in healthy subjects under fed conditions, using a single-dose, open-label, two-way crossover design with at least a one-week washout. Plasma lurasidone concentrations were analyzed by LC-MS/MS, and pharmacokinetic parameters were calculated using Phoenix WinNonlin based on non-compartmental analysis, with bioequivalence assessed using standard two one-sided t-tests. The 90% confidence intervals for all key pharmacokinetic parameters, including AUC and Cmax, fell within the standard 80.00-125.00% acceptance range, and no clinically meaningful differences in safety or tolerability were observed between products. The results demonstrate bioequivalence between the generic and innovator lurasidone products in healthy Caucasian male subjects under fed conditions.