Comparative Bioavailability Study With Two Pantoprazole Delayed-released Tablet Formulations Administered With And Without Food In Healthy Subjects.

dc.creatorMendes, Fabiana D
dc.creatorPatni, Anil K
dc.creatorReyer, Simrit
dc.creatorMonif, Tausif
dc.creatorMoreira, Leonard D
dc.creatorIlha, Jaime O
dc.creatorMendes, Gustavo D
dc.creatorDe Nucci, Gilberto
dc.date2008
dc.date2015-11-27T13:12:50Z
dc.date2015-11-27T13:12:50Z
dc.date.accessioned2018-03-29T01:06:50Z
dc.date.available2018-03-29T01:06:50Z
dc.identifierArzneimittel-forschung. v. 58, n. 3, p. 141-8, 2008.
dc.identifier0004-4172
dc.identifier
dc.identifierhttp://www.ncbi.nlm.nih.gov/pubmed/18488812
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/197810
dc.identifier18488812
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1298043
dc.descriptionTo 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. The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval, in two groups, with and without food. Plasma samples were obtained for up to 24 h 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. 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%-109.8275%) for C(max), 95.6634% (85.2675%-107.3267%) and 89.3500% (83.6630%-95.4237%) for AUC(last). Since the 90% CI 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 bioequivalent to the reference 40 mg DR tablet for both the rate and extent of absorption.
dc.description58
dc.description141-8
dc.languageeng
dc.relationArzneimittel-forschung
dc.relationArzneimittelforschung
dc.rightsaberto
dc.rights
dc.sourcePubMed
dc.subject2-pyridinylmethylsulfinylbenzimidazoles
dc.subjectAdolescent
dc.subjectAdult
dc.subjectArea Under Curve
dc.subjectBiological Availability
dc.subjectChemistry, Pharmaceutical
dc.subjectCross-over Studies
dc.subjectDelayed-action Preparations
dc.subjectFasting
dc.subjectFemale
dc.subjectFood-drug Interactions
dc.subjectHalf-life
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectProton Pump Inhibitors
dc.subjectReproducibility Of Results
dc.titleComparative Bioavailability Study With Two Pantoprazole Delayed-released Tablet Formulations Administered With And Without Food In Healthy Subjects.
dc.typeArtículos de revistas


Este ítem pertenece a la siguiente institución