Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers

4 páginas

Autores:: Vargas Malagón, Mauricio
Villarraga E.
Batista M.
Montenegro L.
Mantilla P.

Tipo de recurso:

Fecha de publicación:: 2016

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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dc.title.es_CO.fl_str_mv	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
title	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
spellingShingle	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers Bioequivalence Isotretinoin Acne Bioavailability Pharmacokinetic
title_short	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
title_full	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
title_fullStr	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
title_full_unstemmed	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
title_sort	Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
dc.creator.fl_str_mv	Vargas Malagón, Mauricio Villarraga E. Batista M. Montenegro L. Mantilla P.
dc.contributor.author.none.fl_str_mv	Vargas Malagón, Mauricio Villarraga E. Batista M. Montenegro L. Mantilla P.
dc.subject.es_CO.fl_str_mv	Bioequivalence Isotretinoin Acne Bioavailability Pharmacokinetic
topic	Bioequivalence Isotretinoin Acne Bioavailability Pharmacokinetic
description	4 páginas
publishDate	2016
dc.date.issued.none.fl_str_mv	2016
dc.date.available.none.fl_str_mv	2019-08-22T17:14:06Z
dc.date.accessioned.none.fl_str_mv	8/22/2019 12:14
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dc.identifier.citation.es_CO.fl_str_mv	Vargas M, Villarraga E, Batista M, Montenegro L, Mantilla P (2016) Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers. J Bioequiv Availab 8: 274-277. doi: 10.4172/jbb.1000308
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identifier_str_mv	Vargas M, Villarraga E, Batista M, Montenegro L, Mantilla P (2016) Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers. J Bioequiv Availab 8: 274-277. doi: 10.4172/jbb.1000308 10.4172/jbb.1000308
url	https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-that-contain-isotretinoin-20mg-capsules-in-healthy-colombian-volunteers-jbb-1000308.pdf http://hdl.handle.net/10818/36771
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	J Bioequiv Availab 2016, 8:6
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dc.publisher.es_CO.fl_str_mv	Journal of Bioequivalence & Bioavailability
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spelling	Vargas Malagón, MauricioVillarraga E.Batista M.Montenegro L.Mantilla P.8/22/2019 12:142019-08-22T17:14:06Z2016Vargas M, Villarraga E, Batista M, Montenegro L, Mantilla P (2016) Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers. J Bioequiv Availab 8: 274-277. doi: 10.4172/jbb.1000308https://www.longdom.org/open-access/bioequivalence-study-of-two-formulations-that-contain-isotretinoin-20mg-capsules-in-healthy-colombian-volunteers-jbb-1000308.pdfhttp://hdl.handle.net/10818/3677110.4172/jbb.10003084 páginasThis is a pharmacokinetic test of two formulations that contain 20 mg of Isotretinoin, with the aim to compare the bioavailability between the Test Product (Isoface® from Procaps Laboratory SA, Colombia) and the Reference Product (Roaccutane® from Catalent Laboratory Germany, Eberbach GMBH, Germany), to declare the bioequivalence between both formulations. An open, crossed study was developed, randomized, of two periods and two sequences, with 40 mg single dose of isotretinoin, on fasting conditions, on 24 healthy male Colombian volunteers; the washout was 14 days in between each period. To present the results, curves of the plasma concentration ratio vs. Time until hour 72 were performed; with the aim to identify the concentration provided by the Test formulation, the basal status of each volunteer was eliminated from the analysis, which was built with 3 former concentrations to the test medicine administration. The analytical method used in this study was high resolution liquid chromatography with tandem mass spectrometry detector, HPLC MS/MS, for plasma Isotretinoin identification and quantification. The main pharmacokinetic parameters for the Test Product vs. the Reference Product were Tmáx 2.6 vs. 2.8 h, Cmáx 190.5 vs. 186.5 ng/mL for the AUC0-t 3003.8 vs. 2933.5 h* ng/mL and AUC0-∞ 3726.3 vs. 3521.2 h* ng/mL. The confidence interval calculation of data with logarithmic transformation, showed confidence intervals for the variables Tmáx, Cmáx, AUCo-t and AUCo-∞, with values between 80-125; values approved by the FDA and EMA European Medicines Agency, in their Bioavailability and Bioequivalence Guides, to accept the Bioequivalence hypothesis between the two formulations in study, and thereby declare Bioequivalence and interchange ability of the Test Product from Procaps Laboratory, with the Reference Product from Roche Laboratoryapplication/pdfengJournal of Bioequivalence & BioavailabilityJ Bioequiv Availab 2016, 8:6Attribution-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 SabanaBioequivalenceIsotretinoinAcneBioavailabilityPharmacokineticBioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules 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/10818/36771/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/36771/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/36771oai:intellectum.unisabana.edu.co:10818/367712023-03-10 18:26:55.969Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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

Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers

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