Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/353524
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dc.contributor.CRUESPUNIVERSIDADE ESTADUAL DE CAMPINASpt_BR
dc.contributor.authorunicampAbib Junior, Eduardo-
dc.contributor.authorunicampSouza, Elisabete Abib Pedroso de-
dc.typeArtigopt_BR
dc.titleStudy of relative bioavailability of two formulations of levofloxacin in healthy volunteers for both sexespt_BR
dc.title.alternativeEstudo de biodisponibilidade relativa de duas formulações de levofioxacino em voluntários sadios de ambos os sexos-
dc.contributor.authorAbib Jr., E.-
dc.contributor.authorDuarte, L. F.-
dc.contributor.authorPereira, R.-
dc.contributor.authorLemes, A. B.-
dc.contributor.authorEstella, M.-
dc.contributor.authorDe Souza, E. A. P.-
dc.contributor.authorMorais, D. C.-
dc.subjectOfloxacinopt_BR
dc.subject.otherlanguageOfloxacinpt_BR
dc.description.abstractThe study was conducted to compare the bioavailability of two formulations of levofloxacin 500 mg tablet (levofloxacin of Aché S/A test formulation and Tavanic® from Sanofi-Aventis Farmacêutica Ltda. reference formulation, Brazil) in 28 volunteers both sexes. This was an open, randomized, two-sequence, two-period, crossover single dose two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Blood samples were obtained throughout a 48 hours interval. The levofloxacin concentrations were determined by mass spectrometry (HPLC-MS-MS) using Ciprofloxacin as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC0-t, AUC0-" and Cmax. The geometric mean of levofloxacin /Tavanic® 500 mg were 107.00% for AUC0-t, 107.07% for AUC0-" and 106.70% for Cmax. The 90% confidence intervals were 103.06-111.09%, 103.16-111.13% and 96.27-118.27%, respectively. Since the confidence intervals 90% for Cmax and AUC0-t was within the range 80-125% proposed by the FDA and ANVISA (National Agency of Sanitary Surveillance in Brazil), it is concluded that the tablet of Levofloxacin 500 mg was bioequivalent to Tavanic® tablet of 500 mg and thus the test product may be considered interchangeable in medical practicept_BR
dc.relation.ispartofRevista brasileira de medicinapt_BR
dc.relation.ispartofabbreviationRBMpt_BR
dc.publisher.citySão Paulo, SPpt_BR
dc.publisher.countryBrasilpt_BR
dc.publisherMoreira Juniorpt_BR
dc.date.issued2014-
dc.date.monthofcirculationNov.pt_BR
dc.language.isoengpt_BR
dc.description.volume71pt_BR
dc.description.issuenumber11pt_BR
dc.rightsFechadopt_BR
dc.sourceSCOPUSpt_BR
dc.identifier.issn0034-7264pt_BR
dc.date.available2021-01-04T13:42:13Z-
dc.date.accessioned2021-01-04T13:42:13Z-
dc.description.provenanceSubmitted by Sanches Olivia (olivias@unicamp.br) on 2021-01-04T13:42:13Z No. of bitstreams: 0en
dc.description.provenanceMade available in DSpace on 2021-01-04T13:42:13Z (GMT). No. of bitstreams: 0 Previous issue date: 2014en
dc.identifier.urihttp://repositorio.unicamp.br/jspui/handle/REPOSIP/353524-
dc.contributor.departmentsem informaçãopt_BR
dc.contributor.departmentsem informaçãopt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.subject.keywordBioavailabilitypt_BR
dc.subject.keywordBioequivalencept_BR
dc.subject.keywordChromatographypt_BR
dc.subject.keywordPharmacokinetics, therapeutic equivalencypt_BR
dc.identifier.source2-s2.0-84919643558pt_BR
dc.creator.orcidsem informaçãopt_BR
dc.creator.orcidsem informaçãopt_BR
dc.type.formArtigopt_BR
dc.description.otherSponsorshipsem informaçãopt_BR
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