Abstract

Background/Objectives: Major Depressive Disorder (MDD) is a complex psychiatric condition characterized by persistent low mood and cognitive dysfunction. Vortioxetine, a multimodal antidepressant, modulates serotonin receptor activity and inhibits the serotonin transporter. This study aimed to evaluate the bioequivalence and in vitro dissolution performance of a generic 20 mg vortioxetine formulation compared to the reference product under fasting conditions in healthy Mexican volunteers. Methods: This was a randomized, open-label, two-period, crossover study. Twenty healthy subjects were enrolled, and 18 completed both periods, with a 4-week washout period between them. Plasma concentrations were quantified using a validated LC-MS/MS method. Results: The 90% confidence intervals (CI) for the geometric mean ratios (Test/Reference) of Cmax and AUC0–72 were 92.32% [84.51–100.85] and 96.77% [91.10–102.80], respectively. Both parameters fell within the 80.00–125.00% bioequivalence acceptance range. No serious adverse events were reported. Conclusions: The generic vortioxetine formulation is bioequivalent to the reference product, supporting its therapeutic interchangeability for the treatment of MDD. NCT07624357.

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