Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

4 páginas

Autores:: Vargas, M.
Villarraga, E.
Vargas, Jba

Tipo de recurso:

Fecha de publicación:: 2014

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

id	REPOUSABA2_3819fc079a04af36442936aa2c80c2da
oai_identifier_str	oai:intellectum.unisabana.edu.co:10818/35845
network_acronym_str	REPOUSABA2
network_name_str	Repositorio Universidad de la Sabana
repository_id_str
spelling	Vargas, M.Villarraga, E.Vargas, Jba6/12/2019 11:062019-06-12T16:06:05Z2014Vargas M, Villarraga E, Vargas Jba (2014) Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study. J Bioequiv Availab 6: 115-118. doi: 10.4172/jbb.100001890975-0851https://www.omicsonline.org/open-access/bioequivalence-study-of-two-mg-desvenlafaxine-extended-release-formulations-a-randomized-singledose-openlabel-two-periods-crossover-study-jbb.1000189.php?aid=30141http://hdl.handle.net/10818/358454 páginasThis is a pharmacokinetic study of two formulations containing Desvenlafaxine succinate 50 mg extended release. Its objective was to compare the bioavailability between the Test product (Desvenlafaxine ER produced by Tecnoquímicas S.A., Colombia laboratory) and the Reference product (Pristiq XR® produced by Wyeth laboratory) and to be able to determine the Bioequivalence between the both of them. For this, an open label, two periods, two previously randomized sequences, crossover, single postprandial 100 mg dose study with an 8 days washout period between each period in 24 healthy volunteers was performed, including the collection of 13 plasma samples within 0 and 48 hours from all volunteers who participated in the clinical phase. The analytical method used was High Performance Liquid Chromatography (HPLC) with UV detector. The obtained mean peak concentration (Cmax) for the Test and Reference products were 215.8 ng/mL and 196.9 ng/mL and for the area under the curve up to 48 hours (AUC0-t) 3849,6 ng.h/mL and 3605,4 ng.h/mL respectively. The 90% confidence interval for the Cmax parameter is within the range of 103,58-113,63 and for the AUC0-t parameter, the 90% confidence interval is within 97,96-111,39. Based on the FDA, EMA and WHO bioequivalence investigation guidelines, the CI is within the allowed ranges for bioequivalence and interchangeability declaration of the Tecnoquímicas S.A. product with the Reference product.application/pdfengJournal of J Bioequivalence & BioavailabilityBioequiv Availab 6(4) 115-118 (2014)Attribution-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 SabanaBioequivalenceDesvenlafaxineAntidepressantPharmacokineticsBioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover StudyBioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations A Randomized, Single-Dose, Open-Label, Two Periods, Crossover 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/10818/35845/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/35845/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/35845oai:intellectum.unisabana.edu.co:10818/358452022-05-10 05:18:22.754Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
dc.title.alternative.en.fl_str_mv	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
title	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
spellingShingle	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study Bioequivalence Desvenlafaxine Antidepressant Pharmacokinetics
title_short	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
title_full	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
title_fullStr	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
title_full_unstemmed	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
title_sort	Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study
dc.creator.fl_str_mv	Vargas, M. Villarraga, E. Vargas, Jba
dc.contributor.author.none.fl_str_mv	Vargas, M. Villarraga, E. Vargas, Jba
dc.subject.es_CO.fl_str_mv	Bioequivalence Desvenlafaxine Antidepressant Pharmacokinetics
topic	Bioequivalence Desvenlafaxine Antidepressant Pharmacokinetics
description	4 páginas
publishDate	2014
dc.date.issued.none.fl_str_mv	2014
dc.date.available.none.fl_str_mv	2019-06-12T16:06:05Z
dc.date.accessioned.none.fl_str_mv	6/12/2019 11:06
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.citation.none.fl_str_mv	Vargas M, Villarraga E, Vargas Jba (2014) Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study. J Bioequiv Availab 6: 115-118. doi: 10.4172/jbb.10000189
dc.identifier.issn.none.fl_str_mv	0975-0851
dc.identifier.other.none.fl_str_mv	https://www.omicsonline.org/open-access/bioequivalence-study-of-two-mg-desvenlafaxine-extended-release-formulations-a-randomized-singledose-openlabel-two-periods-crossover-study-jbb.1000189.php?aid=30141
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/35845
identifier_str_mv	Vargas M, Villarraga E, Vargas Jba (2014) Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study. J Bioequiv Availab 6: 115-118. doi: 10.4172/jbb.10000189 0975-0851
url	https://www.omicsonline.org/open-access/bioequivalence-study-of-two-mg-desvenlafaxine-extended-release-formulations-a-randomized-singledose-openlabel-two-periods-crossover-study-jbb.1000189.php?aid=30141 http://hdl.handle.net/10818/35845
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	Bioequiv Availab 6(4) 115-118 (2014)
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/10818/35845/2/license_rdf https://intellectum.unisabana.edu.co/bitstream/10818/35845/3/license.txt
bitstream.checksum.fl_str_mv	4460e5956bc1d1639be9ae6146a50347 f52a2cfd4df262e08e9b300d62c85cab
bitstream.checksumAlgorithm.fl_str_mv	MD5 MD5
repository.name.fl_str_mv	Intellectum Universidad de la Sabana
repository.mail.fl_str_mv	contactointellectum@unisabana.edu.co
_version_	1811952206890401792

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Publicaciones similares