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Type: Artigo
Title: Study of relative bioavailability of two formulations of levofloxacin in healthy volunteers for both sexes
Title Alternative: Estudo de biodisponibilidade relativa de duas formulações de levofioxacino em voluntários sadios de ambos os sexos
Author: Abib Jr., 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
Subject: Ofloxacino
Country: Brasil
Editor: Moreira Junior
Rights: Fechado
Date Issue: 2014
Appears in Collections:FCM - Artigos e Outros Documentos

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