Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/55568
Type: Artigo de periódico
Title: Bioequivalence of two lithium formulations in healthy volunteers
Author: Guilherme, MC
Pereira, DG
Galuppo, MP
Mendes, GD
Donato, JL
De Nucci, G
Abstract: Objective. The purpose of this study was to compare the maximum exposure and extent of bioavailability of two lithium carbonate (CAS 554-13-2) containing 300 mg tablet formulations (test and reference) for oral administration. Method. This bioequivalence study was conducted in a 2-period crossover design with a washout phase of 7 days. Plasma samples were obtained by blood sampling over 72 h in each period. Twenty-four healthy volunteers of both genders participated in the trial. Samples were analyzed by a flame atomic absorption spectrometer. Resulting Li+ concentrations were used for determination of the pharmacokinetic parameters AUC(last), AUC(inf) and C-max. Results: 90 % confidence intervals for AUC(last), AUC(inf), and C-max were 96.81-107.44 98.44-109.54 % and 98.60-111.33 respectively. Conclusion: All 90 % and 95 % confidence intervals were inside the limits defined by the FDA Guidance for Industry (80 %-125 %) and thus stated that test and reference formulation may be accepted as bioequivalent, with regard to both, maximum exposure and extent of bioavailability.
Subject: CAS 554-13-2
lithium, bioavailability, bioequivalence
mood-stabilizing drug
Country: Alemanha
Editor: Ecv-editio Cantor Verlag Medizin Naturwissenschaften
Rights: aberto
Date Issue: 2006
Appears in Collections:Unicamp - Artigos e Outros Documentos

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