Comparative Bioavailability Of Betahistine Tablet Formulations Administered In Healthy Subjects.

dc.creatorVal, Ligia
dc.creatorChen, Lu Shi
dc.creatorMendes, Gustavo Duarte
dc.creatorDe Nucci, Gilberto
dc.date2010
dc.date2015-11-27T13:18:09Z
dc.date2015-11-27T13:18:09Z
dc.date.accessioned2018-03-29T01:11:27Z
dc.date.available2018-03-29T01:11:27Z
dc.identifierArzneimittel-forschung. v. 60, n. 7, p. 440-4, 2010.
dc.identifier0004-4172
dc.identifier10.1055/s-0031-1296309
dc.identifierhttp://www.ncbi.nlm.nih.gov/pubmed/20712134
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/198995
dc.identifier20712134
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1299228
dc.descriptionTo assess the comparative bioavailability of two formulations (16 mg tablet) of betahistine (CAS 5579-84-0) in healthy volunteers of both sexes. The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Plasma samples were obtained for up to 36 h post dose. Plasma 2-pyridylacetic acid concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the 2-pyridylacetic acid plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained for AUCIast and Cmax. The limit of quantification was 4 ng/mL for plasma 2-pyridylacetic acid analysis. The geometric mean and 90% confidence interval (CI) of test/reference percent ratios were: 98.94% (92.21%-106.16%) for Cmax, 95.42% (91.74%-99.25%) for AUClast. Since the 90% CI for Cmax and AUCs ratios were all within the 80-125% interval proposed by the US Food and Drug Administration Agency, it was concluded that the test formulation is bioequivalent to the reference for both the rate and the extent of absorption.
dc.description60
dc.description440-4
dc.languageeng
dc.relationArzneimittel-forschung
dc.relationArzneimittelforschung
dc.rightsaberto
dc.rights
dc.sourcePubMed
dc.subjectAcetates
dc.subjectAdolescent
dc.subjectAdult
dc.subjectArea Under Curve
dc.subjectBetahistine
dc.subjectBiological Availability
dc.subjectFemale
dc.subjectHalf-life
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPyridines
dc.subjectReference Values
dc.subjectTablets
dc.subjectVasodilator Agents
dc.titleComparative Bioavailability Of Betahistine Tablet Formulations Administered In Healthy Subjects.
dc.typeArtículos de revistas


Este ítem pertenece a la siguiente institución