Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians

Abstract

A study with the aim to compare the bioavailability of two 400 mg imatinib formulations, test product Zeite® from Laboratorio Synthesis S.A.S., Colombia, and reference product Glivec® from Novartis Pharma, and determine if bioequivalence can be declared, was runned. It was an open, four periods and two pre-randomized sequences, crossed study, with a 400mg single dose in fastened and fed conditions, in 30 healthy Colombian volunteers; wash time was 7 days in between periods, with sampling between 0 and 72 hours after drug administration, which was randomly administered in each period. The analytical method used was high performance liquid chromatography with ultraviolet detector, HPLC UV for plasma identification and quantification of imatinib. The confidence interval of 90% of parameters Cmax, AUCall and AUC0-Inf, were taken to statistical analysis and were found, according to the european guidelines for research, which allowed to declare bioequivalence and interchangeability between the products from Laboratorios Synthesis S.A.S. and the reference product from Laboratory Novartis Pharma