Please use this identifier to cite or link to this item:
|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]|
Di Spirito M.
|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.|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.