Avaliação da bioequivalência entre duas formulações de trazodona - comprimidos revestidos de 100 mg

Abstract

Introduction: Trazodone is an atypical antidepressant derived from triazolopyridine, indicated for the treatment of depression with or without episodes of anxiety, pain associated with diabetic neuropathy and other types of chronic pain. Objective: This study aimed to evaluate the bioequivalence between the test formulation of Trazodone 100 mg (Sanofi Medley Farmacêutica Ltda) and the reference product, Donaren (Apsen Farmacêutica S/A) in accordance with the current legislation. Method: A crossover design, open-label, randomized, single-dose study was conducted with healthy individuals of both genders. The clinical phase was conducted with 48 subjects who received the drug under fed conditions. The drug was measured in plasma by liquid chromatography coupled to mass spectrometry (LC-MS/MS). Bioequivalence assessment was based on predefined acceptance criteria of 80.00 – 125.00% for the 90% confidence interval for the ratio of the test and reference products for the logtransformed data of AUC and Cmax, as recommended by Anvisa. Results: Geometric mean ratios (90% confidence intervals) for Cmax and AUC0-t were 103.28% (98.10 – 108.64) and 102.50% (99.87 – 105.19), respectively. There were no adverse events during the study. Conclusion: The test and reference formulations were considered statistically bioequivalent according to regulatory requirements. The test formulation has been available in the local market, contributing to the population's access to quality generic drugs for the treatment of depressive disorders.