Comparative bioavailability study with two pantoprazole delayed-released tablet formulations administered with and without food in healthy subjects

dc.creatorMendes, FD
dc.creatorPatni, AK
dc.creatorReyer, S
dc.creatorMonif, T
dc.creatorMoreira, LD
dc.creatorIlha, JO
dc.creatorMendes, GD
dc.creatorDe Nucci, G
dc.date2008
dc.date2014-08-01T18:27:17Z
dc.date2015-11-26T17:06:56Z
dc.date2014-08-01T18:27:17Z
dc.date2015-11-26T17:06:56Z
dc.date.accessioned2018-03-28T23:55:25Z
dc.date.available2018-03-28T23:55:25Z
dc.identifierArzneimittel-forschung-drug Research. Ecv-editio Cantor Verlag Medizin Naturwissenschaften, v. 58, n. 3, n. 141, n. 148, 2008.
dc.identifier0004-4172
dc.identifierWOS:000255300800008
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/79133
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/79133
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1279992
dc.descriptionObjective. 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.
dc.description58
dc.description3
dc.description141
dc.description148
dc.languageen
dc.publisherEcv-editio Cantor Verlag Medizin Naturwissenschaften
dc.publisherAulendorf
dc.publisherAlemanha
dc.relationArzneimittel-forschung-drug Research
dc.relationArzneimittelforschung
dc.rightsaberto
dc.sourceWeb of Science
dc.subjectCAS 102625-70-7
dc.subjectpantoprazole, bioavailability
dc.subjectbioequivalence, effect of food, pharmacokinetics,quantification
dc.subjectmethod
dc.subjectproton pump inhibitors
dc.subjectPerformance Liquid-chromatography
dc.subjectProton Pump Inhibitors
dc.subjectGastroesophageal-reflux Disease
dc.subjectHuman Plasma
dc.subjectStereoselective Pharmacokinetics
dc.subjectPoor Metabolizers
dc.subjectLansoprazole
dc.titleComparative bioavailability study with two pantoprazole delayed-released tablet formulations administered with and without food in healthy subjects
dc.typeArtículos de revistas


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