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Type: Artigo de periódico
Title: Comparative Study Of Relative Bioavailability Between Two Brazilian Different Commercial Formulations Of Sistemic Isotretinoin [estudo Comparativo De Biodisponibilidade Relativa Entre Duas Formulações Comerciais Distintas De Isotretinoína Sistêmica Existentes No Brasil]
Author: Stirling S.
Di Spirito M.
DiMarco M.
Morelli G.
Tanguay M.
Wada C.Y.
Abstract: This study was conducted to evaluate the bioavailability of a new tablet formulation of isotretinoin and its metabolic 4-oxoisotretinoin (80 mg) relative to a reference product. The bioavailability was carried out in 36 healthy subjects in a randomized balanced 2 X 2 crossover design. After dosing, the blood samples were collected at fixed times for a period of 144 hours. The plasma concentrations of the blood samples were analized by a validated chromatography assay. Pharmacokinetic parameters related to the extent of absorption as the area under concentration curve until t (Auc t and the area until infinity (Auc in) and elimination rates as the maximum concentration (Cmax) were analized under the multiplicative model, that is, using log-transformation of these measures. The average bioequivalence between the two formulations was assessed by the parametric 90% confidence interval for the ratio of mean values of T and R of the pharmacokinetic characteristics. The confidence interval was included in the bioequivalence interval of 80%-125%, in all cases. Schuirmann's two one-sided t tests also supported the conclusion of the test formulation bioequivalent to the reference from isotretinoin and 4-oxoisotretinoin.
Rights: fechado
Identifier DOI: 
Date Issue: 2003
Appears in Collections:Unicamp - Artigos e Outros Documentos

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