Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/79124
Type: Artigo de periódico
Title: Comparative Bioavailability of Two Digoxin Formulations: Determination in Human Plasma by Microparticle Enzyme Immunoassay
Author: Junior, EA
Duarte, LF
Vanunci, MLP
Silva, LC
Pereira, R
Calafatti, S
Junior, JP
Abstract: The present study was performed to compare the bioavailability of two digoxin 0.25 mg tablet formulation in 30 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a three-week washout period. Plasma samples were obtained over a 144 h interval. Digoxin concentrations were analyzed by a validated microparticle enzyme immunoassay with optical detection by fluorescence. Bioequivalence between the products was determined by calculating 90 % confidence intervals (90 % I.C) for the ratio of AUC(0-72h) and C(max) values for the test and reference products, using logarithmic transformed data. The 90 % confidence intervals were 86.98-118.33 %, and 84.52-98.76 %, respectively. Since the 90 % confidence intervals for C(max) and AUC(0-72h) were within the 80-125 % interval proposed by Food and Drug Administration, it was concluded that the two Digoxin formulations are bioequivalent in their rate and extent of absorption.
Subject: Bioequivalence
Digoxin
Pharmacokinetics
Volunteers
Country: Argentina
Editor: Colegio Farmaceuticos Provincia De Buenos Aires
Rights: fechado
Date Issue: 2011
Appears in Collections:Unicamp - Artigos e Outros Documentos

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