Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/79128
Type: Artigo de periódico
Title: Comparative bioavailability of two ramipril formulations after single-dose administration in healthy volunteers
Author: Mendes, GD
Sanfelice, ATD
Borges, NCD
Cavedal, LE
Sverdloff, C
Galuppo, MP
Modolo, JH
De Nucci, G
Abstract: Objective: To assess the bioequivalence of a ramipril 5 mg tablet formulation (ramipril test formulation from Laboratorios Biosintetica Ltda (Sao Paulo, Brazil) and Triatec (R) from Aventis Pharma (Sueano, Brazil) standard reference formulation) in 26 healthy volunteers of both sexes. Methods: The study was conducted using an open, randomized, 2-period crossover design with a 2-week washout interval. Plasma samples were obtained over a 36-hour period. Plasma ramipril and ramiprilat concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the ramipril and ramiprilat plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained: AUC(last), AUC(inf) and C-max. Results: The limit of quantification was 0.2 ng x ml(-1) and 1.0 ng x ml(-1) for ramipril and ramiprilat, respectively. The geometric means and 90% confidence intervals (CI) for Ramipril/Triatec (R) and Ramiprilat/Triatec (R) percent ratios were: 104.69% (90% CI = 93.21 - 117.59%) for C-max, 102.49% (90% CI = 92.76 - 113.24%) for AUC(last), 103.60% (90% CI = 93.56 - 114.73%) for AUC(inf), 108.48% (90% CI = 98.86 - 119.03%) for C-max, 105.88% (90% CI = 101.55 - 110.39%) for AUC(last), 97.30% (90% CI = 90.17 - 104.99%) for AUC(inf), respectively. Conclusion: Since the 90% CI for AUC(last), AUC(inf) and C-max, ratios were within the 80 - 125% interval proposed by the US FDA, it was concluded that the ramipril formulation produced by Laboratorios Biosintetica Ltda is bioequivalent to the Triatec (R) formulation in both rate and extent of absorption.
Subject: tandem mass spectrometry
LC/MS/MS
bioavailability
pharmacokinetics
Country: Alemanha
Editor: Dustri-verlag Dr Karl Feistle
Rights: fechado
Date Issue: 2006
Appears in Collections:Unicamp - Artigos e Outros Documentos

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