{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T09:04:47Z","timestamp":1784192687857,"version":"3.55.0"},"reference-count":39,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T00:00:00Z","timestamp":1784160000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Asofarma de M\u00e9xico S.A. de C.V."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>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\u201372 were 92.32% [84.51\u2013100.85] and 96.77% [91.10\u2013102.80], respectively. Both parameters fell within the 80.00\u2013125.00% 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.<\/jats:p>","DOI":"10.3390\/ph19071093","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T08:08:34Z","timestamp":1784189314000},"page":"1093","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence of a Generic Vortioxetine 20 mg Tablet in Healthy Mexican Volunteers Under Fasting Conditions"],"prefix":"10.3390","volume":"19","author":[{"given":"Porfirio de la Cruz","family":"Cruz","sequence":"first","affiliation":[{"name":"Doctorado Institucional en Ingenier\u00eda y Ciencia de Materiales (DICIM), de la Universidad Aut\u00f3noma de San Luis Potos\u00ed (UASLP), Av. Sierra Leona No. 550 Col. Lomas 2da. Secci\u00f3n, San Luis Potos\u00ed C.P. 78210, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto Mart\u00ednez","family":"Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"FS SCIENTIA PHARMA S.A. de C.V. (Authorized Third Party), Fray Diego de la Magdalena 630, Jard\u00edn, San Luis Potos\u00ed C.P. 78270, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika Gabriela","family":"Guido \u00c1vila","sequence":"additional","affiliation":[{"name":"Asofarma de M\u00e9xico S.A. de C.V., Av. Santa Fe 485, Lomas de Santa Fe, Contadero, Cuajimalpa de Morelos, Ciudad de M\u00e9xico C.P. 05348, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar Emmanuel Hern\u00e1ndez","family":"Pi\u00f1a","sequence":"additional","affiliation":[{"name":"Asofarma de M\u00e9xico S.A. de C.V., Av. Santa Fe 485, Lomas de Santa Fe, Contadero, Cuajimalpa de Morelos, Ciudad de M\u00e9xico C.P. 05348, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4676-1625","authenticated-orcid":false,"given":"Abraham","family":"Escobedo-Moratilla","sequence":"additional","affiliation":[{"name":"Asofarma de M\u00e9xico S.A. de C.V., Av. Santa Fe 485, Lomas de Santa Fe, Contadero, Cuajimalpa de Morelos, Ciudad de M\u00e9xico C.P. 05348, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0642-0033","authenticated-orcid":false,"given":"Jos\u00e9 Trinidad P\u00e9rez","family":"Urizar","sequence":"additional","affiliation":[{"name":"FS SCIENTIA PHARMA S.A. de C.V. (Authorized Third Party), Fray Diego de la Magdalena 630, Jard\u00edn, San Luis Potos\u00ed C.P. 78270, Mexico"},{"name":"Facultad de Ciencias Qu\u00edmicas, de la Universidad Aut\u00f3noma de San Luis Potos\u00ed, Mart\u00ednez #6, Av. Dr. Manuel Nava, Zona Universitaria, San Luis Potos\u00ed C.P. 78210, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1080\/14740338.2022.2019705","article-title":"Vortioxetine in major depressive disorder: From mechanisms of action to clinical studies. An updated review","volume":"21","author":"Crespo","year":"2022","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1037\/a0038550","article-title":"A brief history of the development of antidepressant drugs: From monoamines to glutamate","volume":"23","author":"Hillhouse","year":"2015","journal-title":"Exp. Clin. 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