Bioequivalence of a Generic Vortioxetine 20 mg Tablet in Healthy Mexican Volunteers Under Fasting Conditions.

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.