Journal of Bioequivalence & Bioavailability

Bustamante C

Publications

• Research Article
  Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians
  Author(s): Vargas M, Bustamante C and Villarraga EaVargas M, Bustamante C and Villarraga Ea
  
  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 researc.. View More»
  DOI: 10.4172/jbb.1000245

  Abstract PDF