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dc.contributor.author Baldo, M. N.
dc.contributor.author Hunzicker, Gabriel Alejandro
dc.contributor.author Altamirano, Jorgelina Cecilia
dc.contributor.author Murguia, Marcelo Cesar
dc.contributor.author Hein, Gustavo Juan
dc.date.available 2016-12-22T14:49:42Z
dc.date.issued 2015-05
dc.identifier.citation Baldo, M. N.; Hunzicker, Gabriel Alejandro; Altamirano, Jorgelina Cecilia; Murguia, Marcelo Cesar; Hein, Gustavo Juan; Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers; OMICS; Journal of Bioequivalence & Bioavailability; 7; 3; 5-2015; 108-111
dc.identifier.issn 0975-0851
dc.identifier.uri http://hdl.handle.net/11336/9909
dc.description.abstract The study was performed to compare the bioavailability of two ketoprofen capsule (50 mg) formulations: Flogofin®, as test formulation, and Profenid®, as reference formulation. The study was conducted open with randomized two period crossover design and 1 week washout period in 24 fasting, healthy latino-american male volunteers and performed at the Biopharmaceutical Research Center Dominguez Lab. After dosing, serial blood samples were collected for a period of 24 h and plasma was separated and analyzed for ketoprofen, using a sensitive, reproducible, and accurate method by liquid chromatography ? tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters: AUC0-24, AUC0-∞, Cmax, Tmax, T1/2 and Ke, were analyzed from plasma concentrations of both formulations. The means AUC0-24 for test and reference formulation were 50.21 ([μg h]/mL) - 50.28 ([μgh]/mL), 52.38 ([μg h]/mL) - 50.84 ([μg h]/mL) for AUC0-∞, and 21.58 μg/mL - 21.65 μg/mL for Cmax, respectively. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC0?24, AUC0-∞, and Cmax to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the accepted bioequivalence range of 80%-125%. Based on these statistical inferences, both formulations were found to be bioequivalent.
dc.format application/pdf
dc.language.iso eng
dc.publisher OMICS
dc.rights info:eu-repo/semantics/openAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject KETOPROFEN
dc.subject BIOAVAILABILITY
dc.subject PHARMACOKINETICS
dc.subject MASS SPECTROMETRY
dc.subject.classification Química Analítica
dc.subject.classification Ciencias Químicas
dc.subject.classification CIENCIAS NATURALES Y EXACTAS
dc.title Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
dc.type info:eu-repo/semantics/article
dc.type info:ar-repo/semantics/artículo
dc.type info:eu-repo/semantics/publishedVersion
dc.date.updated 2016-12-16T14:27:42Z
dc.journal.volume 7
dc.journal.number 3
dc.journal.pagination 108-111
dc.journal.pais India
dc.journal.ciudad Chandigarh
dc.description.fil Fil: Baldo, M. N.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Santa Fe. Instituto de Ciencias Veterinarias del Litoral; Argentina. Dominguez Lab; Argentina
dc.description.fil Fil: Hunzicker, Gabriel Alejandro. Dominguez Lab; Argentina
dc.description.fil Fil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Científico Tecnológico Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; Argentina
dc.description.fil Fil: Murguia, Marcelo Cesar. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Santa Fe. Instituto de Desarrollo Tecnológico para la Industria Química (i); Argentina. Universidad Nacional de Cuyo; Argentina
dc.description.fil Fil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Santa Fe. Instituto de Ciencias Veterinarias del Litoral; Argentina. Dominguez Lab; Argentina
dc.journal.title Journal of Bioequivalence & Bioavailability
dc.relation.alternativeid info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.4172/jbb.1000223
dc.relation.alternativeid info:eu-repo/semantics/altIdentifier/url/https://www.omicsonline.org/open-access/bioequivalence-evaluation-of-two-brands-of-ketoprofen-50-mg-capsulesflogofinprofenid-in-healthy-latin-american-volunteers-jbb-1000223.php?aid=49045


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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)