Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians

4 páginas

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

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 E.8/28/2019 14:222019-08-28T19:22:42Z20150975-0851https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-rosuvastatin-40mg-tablets-in-healthy-colombians-jbb-1000245.pdfhttp://hdl.handle.net/10818/3691410.4172/jbb.10002454 páginasThis is a pharmacokinetic study of two formulations containing Rosuvastatin 40 mg, with the aim to compare the Bioavailability between the Test product (Rosuvastatin made by Laboratorios Tecnoquímicas S.A., Colombia) and the Reference product (Crestor® made by Laboratorios AstraZeneca) in order to declare the Bioequivalence between both formulations. For this, an open-label, two period and two sequences previously randomized, crossover study in 30 healthy volunteers was developed, with a single 40 mg dose in fasting conditions, a washout period of 7 days and 14 plasma samples collection between 0 and 48 hours. For the identification and assessment of plasma Rosuvastatin, an ultra-high performance liquid chromatography coupled to tandem mass spectrometer, UHPLC MS/ MS was the analytical method performed.application/pdfengJournal of J Bioequivalence & BioavailabilityJ Bioequiv Availab 2015, 7:5Attribution-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 SabanaBioequivalenceRosuvastatinCholesterolStatinPharmacokineticBioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy ColombiansarticlepublishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/36914/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD53CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805https://intellectum.unisabana.edu.co/bitstream/10818/36914/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD5210818/36914oai:intellectum.unisabana.edu.co:10818/369142022-05-10 05:18:34.695Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
title	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
spellingShingle	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians Bioequivalence Rosuvastatin Cholesterol Statin Pharmacokinetic
title_short	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
title_full	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
title_fullStr	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
title_full_unstemmed	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
title_sort	Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
dc.creator.fl_str_mv	Vargas M. Bustamante C. Villarraga E.
dc.contributor.author.none.fl_str_mv	Vargas M. Bustamante C. Villarraga E.
dc.subject.es_CO.fl_str_mv	Bioequivalence Rosuvastatin Cholesterol Statin Pharmacokinetic
topic	Bioequivalence Rosuvastatin Cholesterol Statin Pharmacokinetic
description	4 páginas
publishDate	2015
dc.date.issued.none.fl_str_mv	2015
dc.date.available.none.fl_str_mv	2019-08-28T19:22:42Z
dc.date.accessioned.none.fl_str_mv	8/28/2019 14:22
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/bioequivalence-study-of-two-formulations-containing-rosuvastatin-40mg-tablets-in-healthy-colombians-jbb-1000245.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/36914
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000245
identifier_str_mv	0975-0851 10.4172/jbb.1000245
url	https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-containing-rosuvastatin-40mg-tablets-in-healthy-colombians-jbb-1000245.pdf http://hdl.handle.net/10818/36914
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	J Bioequiv Availab 2015, 7:5
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 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/10818/36914/3/license.txt https://intellectum.unisabana.edu.co/bitstream/10818/36914/2/license_rdf
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Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians

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