Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People

6 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.7/18/2019 8:542019-07-18T13:54:06Z2015Vargas M, Bustamante C, Villarraga EA (2015) Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People. J Bioequiv Availab 7: 210-215. doi:10.4172/jbb.10002420975-0851https://www.longdom.org/open-access/fed-and-fasting-bioequivalence-study-for-two-formulations-of-bosentan125-mg-tablets-in-healthy-colombian-people-jbb-1000242.pdfhttp://hdl.handle.net/10818/3621710.4172/jbb.10002426 páginasThis is a pharmacokinetic study of two formulations containing Bosentan 125 mg, in order to compare the bioavailability between the Test product (Bosentan produced by Tecnoquímicas S.A. laboratory, Colombia) and the Reference product (Tracleer® produced by Actelion Pharmaceuticals) in fasting and fed conditions, in order to state the bioequivalence between them. With this purpose, an open label, four periods, two randomized sequences, crossover, with single pre- and fed 125 mg dose study was performed in 30 healthy volunteers, with an 8-day washout period between each period and a collection of 14 plasma samples between 0 and 24 hours. Identification and evaluation of Bosentan in plasma was carried out by ultra-high-performance liquid chromatography-tandem mass spectrometry UHPLC/MS/MS as analytical method. Based on the European and FDA bioequivalence research guidelines, the Confidence Interval (CI) falls within the allowed ranges for the Bioequivalence and Interchangeability Statement of the Tecnoquímicas S.A. product with the Reference product. Both formulations had similar pharmacokinetic parameters in each studied condition, fed and fasted. Moreover, an increase in the amount of active pharmaceutical ingredient is evident in fed conditions.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 SabanaBioequivalenceBosentanPulmonary hypertensionEndothelinPharmacokineticsFed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian PeoplearticlepublishedVersionhttp://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/10818/36217/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/36217/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/36217oai:intellectum.unisabana.edu.co:10818/362172022-05-10 05:18:09.181Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
title	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
spellingShingle	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People Bioequivalence Bosentan Pulmonary hypertension Endothelin Pharmacokinetics
title_short	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
title_full	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
title_fullStr	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
title_full_unstemmed	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
title_sort	Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People
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 Bosentan Pulmonary hypertension Endothelin Pharmacokinetics
topic	Bioequivalence Bosentan Pulmonary hypertension Endothelin Pharmacokinetics
description	6 páginas
publishDate	2015
dc.date.issued.none.fl_str_mv	2015
dc.date.available.none.fl_str_mv	2019-07-18T13:54:06Z
dc.date.accessioned.none.fl_str_mv	7/18/2019 8:54
dc.type.en.fl_str_mv	article
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dc.identifier.citation.es_CO.fl_str_mv	Vargas M, Bustamante C, Villarraga EA (2015) Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People. J Bioequiv Availab 7: 210-215. doi:10.4172/jbb.1000242
dc.identifier.issn.none.fl_str_mv	0975-0851
dc.identifier.other.none.fl_str_mv	https://www.longdom.org/open-access/fed-and-fasting-bioequivalence-study-for-two-formulations-of-bosentan125-mg-tablets-in-healthy-colombian-people-jbb-1000242.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/36217
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000242
identifier_str_mv	Vargas M, Bustamante C, Villarraga EA (2015) Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People. J Bioequiv Availab 7: 210-215. doi:10.4172/jbb.1000242 0975-0851 10.4172/jbb.1000242
url	https://www.longdom.org/open-access/fed-and-fasting-bioequivalence-study-for-two-formulations-of-bosentan125-mg-tablets-in-healthy-colombian-people-jbb-1000242.pdf http://hdl.handle.net/10818/36217
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
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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
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Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People

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