Journal of Bioequivalence & Bioavailability

Montenegro L

Publications

• Research Article
  Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers
  Author(s): Vargas M1, Villarraga E, Batista M, Montenegro L and Mantilla P Vargas M1, Villarraga E, Batista M, Montenegro L and Mantilla P
  
  This is a pharmacokinetic test of two formulations that contain 20 mg of Isotretinoin, with the aim to compare the bioavailability between the Test Product (Isoface® from Procaps Laboratory SA, Colombia) and the Reference Product (Roaccutane® from Catalent Laboratory Germany, Eberbach GMBH, Germany), to declare the bioequivalence between both formulations. An open, crossed study was developed, randomized, of two periods and two sequences, with 40 mg single dose of isotretinoin, on fasting conditions, on 24 healthy male Colombian volunteers; the washout was 14 days in between each period. To present the results, curves of the plasma concentration ratio vs. Time until hour 72 were performed; with the aim to identify the concentration provided by the Test formulation, the basal status of each volunteer was eliminated from the analysis, which was built with 3 form.. View More»
  DOI: 10.4172/jbb.1000308

  Abstract PDF