600 mg Oxcarbazepine Tablets Bioequivalence Study

4 páginas

Autores:: Vargas, M.
Villarraga, EA

Tipo de recurso:

Fecha de publicación:: 2017

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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spelling	Vargas, M.Villarraga, EA7/26/2019 9:412019-07-26T14:41:43Z20170975-0851https://www.longdom.org/open-access/600-mg-oxcarbazepine-tablets-bioequivalence-study-jbb-1000350.pdfhttp://hdl.handle.net/10818/3638410.4172/jbb.10003504 páginasBioequivalence studies are evidence of generic drugs quality, demonstrating that the rate and quantity of effective substance absorbed from each of the studied formulations, showed no significant differences. The aim of the pharmacokinetic study of the two formulations, containing 600 mg of Oxcarbazepine, is to analyse bioavailability between the Test Product (Oxicodal® from Synthesis Laboratory S.A.S, Colombia) and the Reference Product (Trileptal® from Novartis Laboratory) and to affirm the Bioequivalence. Therefore, a study was developed in 24 healthy volunteers; an open, four periods and four randomized sequences, with one dose of 600 mg during fasting and postprandial conditions, and 7-day wash time between each period study. Conducting the study in 4 periods obeys the need to know if there are differences in relation to the presence or not of food during the bioavailability of the formulations studied. The benefits sought in this study are to offer public health a guarantee of quality, safety and inter-changeability of the drugs studied to increase the population's access to generic medicines. The analytical method used was HPLC chromatography UV detector. The 90% confidence interval for the parameters Cmax, AUC0-t and AUC0-∞, according to European guidelines and the FDA is within the permitted ranges for the declaration of bioequivalence and compatibility of the Synthesis S.A.S (Colombia) product Oxicodal®, with the Novartis Laboratories Reference Product Trileptal®, for both feeding conditions, fasting and postprandial.application/pdfengJournal of Bioequivalence & BioavailabilityJ Bioequiv Availab 2017, 9:5Attribution-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 SabanaBioequivalenceOxcarbazepineAnticonvulsantPharmacokinetic600 mg Oxcarbazepine Tablets Bioequivalence StudyarticlepublishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805https://intellectum.unisabana.edu.co/bitstream/10818/36384/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/36384/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/36384oai:intellectum.unisabana.edu.co:10818/363842022-05-10 05:18:33.277Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	600 mg Oxcarbazepine Tablets Bioequivalence Study
title	600 mg Oxcarbazepine Tablets Bioequivalence Study
spellingShingle	600 mg Oxcarbazepine Tablets Bioequivalence Study Bioequivalence Oxcarbazepine Anticonvulsant Pharmacokinetic
title_short	600 mg Oxcarbazepine Tablets Bioequivalence Study
title_full	600 mg Oxcarbazepine Tablets Bioequivalence Study
title_fullStr	600 mg Oxcarbazepine Tablets Bioequivalence Study
title_full_unstemmed	600 mg Oxcarbazepine Tablets Bioequivalence Study
title_sort	600 mg Oxcarbazepine Tablets Bioequivalence Study
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 Oxcarbazepine Anticonvulsant Pharmacokinetic
topic	Bioequivalence Oxcarbazepine Anticonvulsant Pharmacokinetic
description	4 páginas
publishDate	2017
dc.date.issued.none.fl_str_mv	2017
dc.date.available.none.fl_str_mv	2019-07-26T14:41:43Z
dc.date.accessioned.none.fl_str_mv	7/26/2019 9:41
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.issn.none.fl_str_mv	0975-0851
dc.identifier.other.none.fl_str_mv	https://www.longdom.org/open-access/600-mg-oxcarbazepine-tablets-bioequivalence-study-jbb-1000350.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/36384
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000350
identifier_str_mv	0975-0851 10.4172/jbb.1000350
url	https://www.longdom.org/open-access/600-mg-oxcarbazepine-tablets-bioequivalence-study-jbb-1000350.pdf http://hdl.handle.net/10818/36384
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	J Bioequiv Availab 2017, 9:5
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/10818/36384/2/license_rdf https://intellectum.unisabana.edu.co/bitstream/10818/36384/3/license.txt
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600 mg Oxcarbazepine Tablets Bioequivalence Study

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