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dc.contributor.authorVargas M.
dc.contributor.authorVillarraga EA
dc.date.accessioned8/29/2019 10:19
dc.date.available2019-08-29T15:19:41Z
dc.date.issued2016
dc.identifier.otherhttps://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-lurasidone-80-mgtablets-in-healthy-colombian-volunteers-jbb-1000299.pdf
dc.identifier.urihttp://hdl.handle.net/10818/36945
dc.description4 páginases_CO
dc.description.abstractThis is a pharmacokinetic study of two formulations containing Lurasidone 80 mg, with the aim to compare the Bioavailability between the Test product (Lurasidone made by Laboratorios Lafrancol S.A, Colombia) and the Reference product (Latuda® made by Laboratorio Sunovion) in order to declare the Bioequivalence between both formulations. For this, an open-label, two period and two sequences previously randomized, crossover study in 24 healthy volunteers was developed, with a single 80 mg dose in fasting conditions, a washout period of 15 days and 12 plasma samples collection between 0 and 72 h. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 96.4–103.7 with a 103.2 ratio; for the AUC0-t parameter the 90% CI it is between 86.8-107.4 with a 98.2 ratio, and for the AUC0-∞ the 90% CI was found to be between 90.4–108.9 with a 99.2 ratio. According to the European and FDA guidelines for Bioequivalence research, the confidence interval is within the allowed ranges for the Bioequivalence declaration and interchangeability of the Lafrancol S.A. product with the Reference product.en
dc.formatapplication/pdfes_CO
dc.language.isoenges_CO
dc.publisherJournal of Bioequivalence & Bioavailabilityes_CO
dc.relation.ispartofseriesJ Bioequiv Availab 2016, 8:5
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.sourceUniversidad de La Sabanaes_CO
dc.sourceIntellectum Repositorio Universidad de La Sabanaes_CO
dc.subjectBioequivalencees_CO
dc.subjectLurasidonees_CO
dc.subjectAntidepressantes_CO
dc.subjectPharmacokineticses_CO
dc.titleBioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteerses_CO
dc.typearticleen
dc.type.hasVersionpublishedVersiones_CO
dc.rights.accessRightsopenAccesses_CO
dc.identifier.doi10.4172/jbb.1000299


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