Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers

Autores
Baldo, M. N.; Hunzicker, Gabriel Alejandro; Altamirano, Jorgelina Cecilia; Murguia, Marcelo Cesar; Hein, Gustavo Juan
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
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
Fil: Hunzicker, Gabriel Alejandro. Dominguez Lab; Argentina
Fil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Científico Tecnológico Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; Argentina
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
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
Materia
KETOPROFEN
BIOAVAILABILITY
PHARMACOKINETICS
MASS SPECTROMETRY
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/9909
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteersBaldo, M. N.Hunzicker, Gabriel AlejandroAltamirano, Jorgelina CeciliaMurguia, Marcelo CesarHein, Gustavo JuanKETOPROFENBIOAVAILABILITYPHARMACOKINETICSMASS SPECTROMETRYhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1The 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.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; ArgentinaFil: Hunzicker, Gabriel Alejandro. Dominguez Lab; ArgentinaFil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Científico Tecnológico Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; ArgentinaFil: 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; ArgentinaFil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Santa Fe. Instituto de Ciencias Veterinarias del Litoral; Argentina. Dominguez Lab; ArgentinaOMICS2015-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/9909Baldo, 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; 108-1110975-0851enginfo:eu-repo/semantics/altIdentifier/doi/10.4172/jbb.1000223info: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=49045info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-10T12:59:59Zoai:ri.conicet.gov.ar:11336/9909instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-10 13:00:00.236CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
title Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
spellingShingle Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
Baldo, M. N.
KETOPROFEN
BIOAVAILABILITY
PHARMACOKINETICS
MASS SPECTROMETRY
title_short Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
title_full Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
title_fullStr Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
title_full_unstemmed Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
title_sort Bioequivalence evaluation of two brands of ketoprofen 50 mg capsules (Flogofin® & Profenid®) in healthy latin american volunteers
dc.creator.none.fl_str_mv Baldo, M. N.
Hunzicker, Gabriel Alejandro
Altamirano, Jorgelina Cecilia
Murguia, Marcelo Cesar
Hein, Gustavo Juan
author Baldo, M. N.
author_facet Baldo, M. N.
Hunzicker, Gabriel Alejandro
Altamirano, Jorgelina Cecilia
Murguia, Marcelo Cesar
Hein, Gustavo Juan
author_role author
author2 Hunzicker, Gabriel Alejandro
Altamirano, Jorgelina Cecilia
Murguia, Marcelo Cesar
Hein, Gustavo Juan
author2_role author
author
author
author
dc.subject.none.fl_str_mv KETOPROFEN
BIOAVAILABILITY
PHARMACOKINETICS
MASS SPECTROMETRY
topic KETOPROFEN
BIOAVAILABILITY
PHARMACOKINETICS
MASS SPECTROMETRY
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv 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.
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
Fil: Hunzicker, Gabriel Alejandro. Dominguez Lab; Argentina
Fil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Científico Tecnológico Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; Argentina
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
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
description 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.
publishDate 2015
dc.date.none.fl_str_mv 2015-05
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/9909
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
0975-0851
url http://hdl.handle.net/11336/9909
identifier_str_mv 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
0975-0851
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.4172/jbb.1000223
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
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv OMICS
publisher.none.fl_str_mv OMICS
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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