Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers

4 páginas

Autores:: Vargas M.
Villarraga EA

Tipo de recurso:

Fecha de publicación:: 2016

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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spelling	Vargas M.Villarraga EA8/29/2019 10:192019-08-29T15:19:41Z2016https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-lurasidone-80-mgtablets-in-healthy-colombian-volunteers-jbb-1000299.pdfhttp://hdl.handle.net/10818/3694510.4172/jbb.10002994 páginasThis 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.application/pdfengJournal of Bioequivalence & BioavailabilityJ Bioequiv Availab 2016, 8:5Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/http://purl.org/coar/access_right/c_abf2Universidad de La SabanaIntellectum Repositorio Universidad de La SabanaBioequivalenceLurasidoneAntidepressantPharmacokineticsBioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian VolunteersarticlepublishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/36945/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD53CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805https://intellectum.unisabana.edu.co/bitstream/10818/36945/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD5210818/36945oai:intellectum.unisabana.edu.co:10818/369452022-05-10 05:18:36.719Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
title	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
spellingShingle	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers Bioequivalence Lurasidone Antidepressant Pharmacokinetics
title_short	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
title_full	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
title_fullStr	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
title_full_unstemmed	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
title_sort	Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers
dc.creator.fl_str_mv	Vargas M. Villarraga EA
dc.contributor.author.none.fl_str_mv	Vargas M. Villarraga EA
dc.subject.es_CO.fl_str_mv	Bioequivalence Lurasidone Antidepressant Pharmacokinetics
topic	Bioequivalence Lurasidone Antidepressant Pharmacokinetics
description	4 páginas
publishDate	2016
dc.date.issued.none.fl_str_mv	2016
dc.date.available.none.fl_str_mv	2019-08-29T15:19:41Z
dc.date.accessioned.none.fl_str_mv	8/29/2019 10:19
dc.type.en.fl_str_mv	article
dc.type.coarversion.fl_str_mv	http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.coar.fl_str_mv	http://purl.org/coar/resource_type/c_6501
dc.type.hasVersion.es_CO.fl_str_mv	publishedVersion
dc.identifier.other.none.fl_str_mv	https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-lurasidone-80-mgtablets-in-healthy-colombian-volunteers-jbb-1000299.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/36945
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000299
url	https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-lurasidone-80-mgtablets-in-healthy-colombian-volunteers-jbb-1000299.pdf http://hdl.handle.net/10818/36945
identifier_str_mv	10.4172/jbb.1000299
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	J Bioequiv Availab 2016, 8:5
dc.rights.*.fl_str_mv	Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.coar.fl_str_mv	http://purl.org/coar/access_right/c_abf2
dc.rights.uri.*.fl_str_mv	http://creativecommons.org/licenses/by-nc-nd/4.0/
rights_invalid_str_mv	Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ http://purl.org/coar/access_right/c_abf2
dc.format.es_CO.fl_str_mv	application/pdf
dc.publisher.es_CO.fl_str_mv	Journal of Bioequivalence & Bioavailability
dc.source.es_CO.fl_str_mv	Universidad de La Sabana Intellectum Repositorio Universidad de La Sabana
institution	Universidad de la Sabana
bitstream.url.fl_str_mv	https://intellectum.unisabana.edu.co/bitstream/10818/36945/3/license.txt https://intellectum.unisabana.edu.co/bitstream/10818/36945/2/license_rdf
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Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers

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