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dc.contributor.CRUESPUNIVERSIDADE ESTADUAL DE CAMPINASpt_BR
dc.contributor.authorunicampAbib Junior, Eduardo-
dc.typeArtigopt_BR
dc.titleAverage bioequivalence of single 500 mg doses of two oral formulations of levofloxacin : a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteerspt_BR
dc.contributor.authorKano, Eunice Kazue-
dc.contributor.authorKoono, Eunice Emiko Mori-
dc.contributor.authorSchramm, Simone Grigoleto-
dc.contributor.authorSerra, Cristina Helena dos Reis-
dc.contributor.authorAbib Junior, Eduardo-
dc.contributor.authorPereira, Renata-
dc.contributor.authorFreitas, Márcia Sayuri Takamatsu-
dc.contributor.authorIecco, Maria Cristina-
dc.contributor.authorPorta, Valentina-
dc.subjectFarmacocinéticapt_BR
dc.subject.otherlanguagePharmacokineticspt_BR
dc.description.abstractAverage bioequivalence of two 500 mg levofloxacin formulations available in Brazil, Tavanic(c) (Sanofi-Aventis Farmacêutica Ltda, Brazil, reference product) and Levaquin(c) (Janssen-Cilag Farmacêutica Ltda, Brazil, test product) was evaluated by means of a randomized, open-label, 2-way crossover study performed in 26 healthy Brazilian volunteers under fasting conditions. A single dose of 500 mg levofloxacin tablets was orally administered, and blood samples were collected over a period of 48 hours. Levofloxacin plasmatic concentrations were determined using a validated HPLC method. Pharmacokinetic parameters Cmax, Tmax, Kel, T1/2el, AUC0-t and AUC0-inf were calculated using noncompartmental analysis. Bioequivalence was determined by calculating 90% confidence intervals (90% CI) for the ratio of Cmax, AUC0-t and AUC0-inf values for test and reference products, using logarithmic transformed data. Tolerability was assessed by monitoring vital signs and laboratory analysis results, by subject interviews and by spontaneous report of adverse events. 90% CIs for Cmax, AUC0-t and AUC0-inf were 92.1% - 108.2%, 90.7% - 98.0%, and 94.8% - 100.0%, respectively. Observed adverse events were nausea and headache. It was concluded that Tavanic(c) and Levaquin(c) are bioequivalent, since 90% CIs are within the 80% - 125% interval proposed by regulatory agenciespt_BR
dc.relation.ispartofBrazilian journal of pharmaceutical sciences = Revista brasileira de ciencias farmaceuticaspt_BR
dc.relation.ispartofabbreviationBraz. j. pharm. sci.pt_BR
dc.publisher.citySão Paulo, SPpt_BR
dc.publisher.countryBrasilpt_BR
dc.publisherUSP/Faculdade de Ciências Farmacêuticaspt_BR
dc.date.issued2015-
dc.date.monthofcirculationJan./Mar.pt_BR
dc.language.isoengpt_BR
dc.description.volume51pt_BR
dc.description.issuenumber1pt_BR
dc.rightsAbertopt_BR
dc.sourceWOSpt_BR
dc.identifier.issn1984-8250pt_BR
dc.identifier.eissn2175-9790pt_BR
dc.identifier.doi10.1590/S1984-82502015000100020pt_BR
dc.identifier.urlhttps://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000100203pt_BR
dc.date.available2021-01-21T14:29:27Z-
dc.date.accessioned2021-01-21T14:29:27Z-
dc.description.provenanceSubmitted by Susilene Barbosa da Silva (susilene@unicamp.br) on 2021-01-21T14:29:27Z No. of bitstreams: 0. Added 1 bitstream(s) on 2021-02-26T13:23:13Z : No. of bitstreams: 1 000357744100020.pdf: 454382 bytes, checksum: c1e6d682e58f3f08e80545e6f3994aae (MD5)en
dc.description.provenanceMade available in DSpace on 2021-01-21T14:29:27Z (GMT). No. of bitstreams: 0 Previous issue date: 2015en
dc.identifier.urihttp://repositorio.unicamp.br/jspui/handle/REPOSIP/354550-
dc.contributor.departmentSem informaçãopt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.subject.keywordLevofloxacinopt_BR
dc.identifier.source000357744100020pt_BR
dc.creator.orcidSem informaçãopt_BR
dc.type.formArtigopt_BR
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