Research Article
Mohammad Safiqul Islam, Nahia
Abstract
Bioequivalence study of two esomeprazole 20 mg capsule formulations namely Esolok ® 20 (Test product) and Nexium 20 (Reference product) was carried out in the present study. 24 healthy male volunteers were enrolled into this randomized, single-dose, two-period, crossover, open-label pharmacokinetic study with one week washout period. After administering a single dose of 20 mg of each formulation, blood samples were collected at different time intervals and analyzed for esomeprazole concentrations using a validated HPLC method. Non-compartmental method was used to determine different pharmacokinetic parameters. Obtained mean (SD) values for the test and reference products were 1.45 (0.53) and 1.53 (0.47) μg/ml for C max ; 2.25 (0.57) and 2.21 (0.71) hr for T max ; 4.38 (2.04) and 4.37 (2.35) hr-μg/ml for AUC 0-12 ; and 4.59 (1.99) and 4.62 (2.39) hr-μg/ml for AUC 0-∞ , respectively. The 90% CIs of the test/reference mean ratios of the ln-transformed AUC 0-12 , AUC 0-∞ and C max mean values were 102.51% (88.10% – 119.27%), 101.92% (87.32% – 118.96%) and 92.56% (85.73% – 99.93%) respectively, which were within the predetermined FDA bioequivalence range of 80% – 125%. In conclusion, the test and reference formulations of esomeprazole meet the regulatory criteria for bioequivalence both in terms of rate and extent of absorption.