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Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers BJPS
Kano,Eunice Kazue; Koono,Eunice Emiko Mori; Schramm,Simone Grigoleto; Serra,Cristina Helena dos Reis; Abib Junior,Eduardo; Pereira,Renata; Freitas,Márcia Sayuri Takamatsu; Iecco,Maria Cristina; Porta,Valentina.
Average 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%...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Levofloxacin/bioequivalence; Pharmacokinetics; High-performance liquid chromatography/qualitative analysis; Tavanic(c)/bioequivalence; Levaquin(c)/bioequivalence.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000100203
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