Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers

5 páginas

Autores:: Vargas M.
Bustamante C.
Villarraga EA.

Tipo de recurso:

Fecha de publicación:: 2015

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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spelling	Vargas M.Bustamante C.Villarraga EA.10/7/2019 11:522019-10-07T16:52:33Z2015https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-irbesartan-300-mgtablets-in-healthy-colombian-volunteers-jbb-1000237.pdfhttp://hdl.handle.net/10818/3754310.4172/jbb.10002375 páginasThis is a pharmacokinetic study of two formulations containing Irbesartan 300 mg. Its objective was to compare the Bioavailability between the Test product (Irbesartan produced by Tecnoquímicas S.A., Colombia laboratory) and the Reference product (Aprovel® produced by Sanofi Aventis laboratory) in order to be able to state the Bioequivalence between them. For this, an open label, two periods, two randomized sequences, crossover, single fasting 300 mg dose study was performed with an 8-day washout period between each period in 24 healthy volunteers and collection of 12 plasma samples between 0 and 48 hours. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 83.0 – 113.9 with a 97.2 ratio; for the AUC0-t parameter the 90% CI it is between 92.1 -116.7 with a 103.7 ratio, and for the AUC0-∞ the 90% CI was found to be between 95.5 – 114.8 with a 104.7 ratio.application/pdfengJournal of J Bioequivalence & BioavailabilityBioequiv Availab 2015, 7:4Attribution-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 SabanaBioequivalenceIrbesartanAntihypertensivePharmacokineticsBioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian VolunteersarticlepublishedVersionhttp://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/10818/37543/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/37543/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/37543oai:intellectum.unisabana.edu.co:10818/375432022-05-10 05:19:24.139Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
title	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
spellingShingle	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers Bioequivalence Irbesartan Antihypertensive Pharmacokinetics
title_short	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
title_full	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
title_fullStr	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
title_full_unstemmed	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
title_sort	Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
dc.creator.fl_str_mv	Vargas M. Bustamante C. Villarraga EA.
dc.contributor.author.none.fl_str_mv	Vargas M. Bustamante C. Villarraga EA.
dc.subject.es_CO.fl_str_mv	Bioequivalence Irbesartan Antihypertensive Pharmacokinetics
topic	Bioequivalence Irbesartan Antihypertensive Pharmacokinetics
description	5 páginas
publishDate	2015
dc.date.accessioned.none.fl_str_mv	10/7/2019 11:52
dc.date.issued.none.fl_str_mv	2015
dc.date.available.none.fl_str_mv	2019-10-07T16:52:33Z
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-irbesartan-300-mgtablets-in-healthy-colombian-volunteers-jbb-1000237.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/37543
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000237
url	https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-irbesartan-300-mgtablets-in-healthy-colombian-volunteers-jbb-1000237.pdf http://hdl.handle.net/10818/37543
identifier_str_mv	10.4172/jbb.1000237
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	Bioequiv Availab 2015, 7:4
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 J 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/10818/37543/2/license_rdf https://intellectum.unisabana.edu.co/bitstream/10818/37543/3/license.txt
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Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers

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