Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians

Abstract

This is a pharmacokinetic study of two formulations containing Rosuvastatin 40 mg, with the aim to compare the Bioavailability between the Test product (Rosuvastatin made by Laboratorios Tecnoquímicas S.A., Colombia) and the Reference product (Crestor® made by Laboratorios AstraZeneca) in order to declare the Bioequivalence between both formulations. For this, an open-label, two period and two sequences previously randomized, crossover study in 30 healthy volunteers was developed, with a single 40 mg dose in fasting conditions, a washout period of 7 days and 14 plasma samples collection between 0 and 48 hours. For the identification and assessment of plasma Rosuvastatin, an ultra-high performance liquid chromatography coupled to tandem mass spectrometer, UHPLC MS/ MS was the analytical method performed. According to the European and FDA guidelines for Bioequivalence research, the confidence interval is within the allowed ranges for the Bioequivalence declaration and interchangeability of the Tecnoquímicas S.A. product with the Reference product.