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dc.contributor.CRUESPUniversidade Estadual de Campinaspt_BR
dc.typeArtigo de periódicopt_BR
dc.titleComparative bioavailability study with two pantoprazole delayed-released tablet formulations administered with and without food in healthy subjectspt_BR
dc.contributor.authorMendes, FDpt_BR
dc.contributor.authorPatni, AKpt_BR
dc.contributor.authorReyer, Spt_BR
dc.contributor.authorMonif, Tpt_BR
dc.contributor.authorMoreira, LDpt_BR
dc.contributor.authorIlha, JOpt_BR
dc.contributor.authorMendes, GDpt_BR
dc.contributor.authorDe Nucci, Gpt_BR
unicamp.author.emailgugamendes@terra.com.brpt_BR
unicamp.authorMendes, Fabiana D. Moreira, Leonard D. Mendes, Gustavo D. De Nucci, Gilberto Univ Estadual Campinas, Fac Med Sci, Dept Internal Med, BR-13092320 Campinas, SP, Brazilpt_BR
unicamp.authorIlha, Jaime O. Mendes, Gustavo D. De Nucci, Gilberto ICB USP, Dept Pharmacol, Cartesius Analyt Unit, Sao Paulo, SP, Brazilpt_BR
unicamp.authorMendes, Gustavo D. De Nucci, Gilberto Univ Estadual Campinas, Fac Med Sci, Dept Pharmacol, Campinas, SP, Brazilpt_BR
dc.subjectCAS 102625-70-7pt_BR
dc.subjectpantoprazole, bioavailabilitypt_BR
dc.subjectbioequivalence, effect of food, pharmacokinetics,quantificationpt_BR
dc.subjectmethodpt_BR
dc.subjectproton pump inhibitorspt_BR
dc.subject.wosPerformance Liquid-chromatographypt_BR
dc.subject.wosProton Pump Inhibitorspt_BR
dc.subject.wosGastroesophageal-reflux Diseasept_BR
dc.subject.wosHuman Plasmapt_BR
dc.subject.wosStereoselective Pharmacokineticspt_BR
dc.subject.wosPoor Metabolizerspt_BR
dc.subject.wosLansoprazolept_BR
dc.description.abstractObjective. To assess the comparative bioavailability of two formulations (40 mg delayed-released [DR] tablet; test and reference) of pantoprazole (CAS 102625-70-7) in healthy volunteers of both sexes, with and without food. Methods: The study was conducted using an open, randomized, two-period crossover design with a I-week washout interval, in two groups, with and without food. Plasma samples were obtained for up to 24 It post dose. Plasma pantoprazole concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reactions monitoring (MRM). From the pantoprazole plasma concentration vs. time curves, the pharmacokinetic parameters AUC(last) and C-max were obtained, with and without food. Results. The limit of quantification was 5 ng/mL for plasma pantoprazole analysis. The geometric mean and 90% confidence interval CI of test/reference percent ratios were, without and with food, respectively: 104.6540% (90.8616%-120.5401%) and 99.9708% (90.9987 %-09.8275%) for C-max 95.6634 % (85.2675%-07.3267%) and 89.3500% (83.6630%-95.4237%) for AUC(last). Conclusion: Since the 90 % Cl for AUC(last) and C-max ratios were within the 80-125% interval proposed by the US FDA, it was concluded that pantoprazole 40 mg DR tablet (test formulation) with and without food was bloequivalent to the reference 40 mg DR tablet for both the rate and extent of absorption.pt
dc.relation.ispartofArzneimittel-forschung-drug Researchpt_BR
dc.relation.ispartofabbreviationArzneimittelforschungpt_BR
dc.publisher.cityAulendorfpt_BR
dc.publisher.countryAlemanhapt_BR
dc.publisherEcv-editio Cantor Verlag Medizin Naturwissenschaftenpt_BR
dc.date.issued2008pt_BR
dc.identifier.citationArzneimittel-forschung-drug Research. Ecv-editio Cantor Verlag Medizin Naturwissenschaften, v. 58, n. 3, n. 141, n. 148, 2008.pt_BR
dc.language.isoenpt_BR
dc.description.volume58pt_BR
dc.description.issuenumber3pt_BR
dc.description.firstpage141pt_BR
dc.description.lastpage148pt_BR
dc.rightsabertopt_BR
dc.sourceWeb of Sciencept_BR
unicamp.cruespUSPpt_BR
dc.identifier.issn0004-4172pt_BR
dc.identifier.wosidWOS:000255300800008pt_BR
dc.date.available2014-08-01T18:27:17Z
dc.date.available2015-11-26T17:06:56Z-
dc.date.accessioned2014-08-01T18:27:17Z
dc.date.accessioned2015-11-26T17:06:56Z-
dc.description.provenanceMade available in DSpace on 2014-08-01T18:27:17Z (GMT). No. of bitstreams: 0 Previous issue date: 2008en
dc.description.provenanceMade available in DSpace on 2015-11-26T17:06:56Z (GMT). No. of bitstreams: 0 Previous issue date: 2008en
dc.identifier.urihttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/79133
dc.identifier.urihttp://repositorio.unicamp.br/jspui/handle/REPOSIP/79133-
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