Bioequivalence Study Comparing a Generic and Innovator Drug of Rosuvastatin 20 mg

Abstract

The bioequivalence study was conducted to compare the bioavailability of two rosuvastatin 20 mg film-coated tablet formulations (test and reference formulation). This study was an open-label, randomized, single-dose, two-periods, twotreatments, and crossover study which included 32 healthy adult male and female subjects under fasting conditions. Each of the two study periods was separated by a 7 days washout period. A single oral dose of test or reference drug was administered to the subject in each period based on the randomization scheme. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 72 h (AUC0-72h), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (Tmax), and the elimination half-life (T1/2). The geometric mean ratio (GMR) and 90% Confidence Interval (90% CI) for AUC0-72h and Cmax of test/reference drug for rosuvastatin were 97.05 % (89.07%– 105.74%) and 101.15% (89.53%– 114.26%). Since the 90% CI with α 0.05% for AUC0-72h and Cmax of rosuvastatin were within the standard bioequivalence range (80.00– 125.00%), it was concluded that the two rosuvastatin film-coated tablets (test and reference drug) were bioequivalence in terms of the rate and extent of absorption.