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Type: Artigo de periódico
Title: Study Of Relative Bioavailability Of Two Formulations Of Levofloxacin In Healthy Volunteers For Both Sexes [estudo De Biodisponibilidade Relativa De Duas Formulações De Levofioxacino Em Voluntários Sadios De Ambos Os Sexos]
Author: Abib E.
Duarte L.F.
Pereira R.
Lemes A.B.
Estella M.
De Souza E.A.P.
Morais D.C.
Abstract: The 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 practice.
Editor: Moreira Junior Editora Ltda.
Rights: fechado
Identifier DOI: 
Date Issue: 2014
Appears in Collections:Unicamp - Artigos e Outros Documentos

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