生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Evaluation of Two Esomeprazole 20 mg Capsule Formulations in Healthy Male Bangladeshi Volunteers

Mohammad Safiqul Islam, Nahia Akter, Hasanuzzaman Shohag, Ashik Ullah, Abdullah Al Maruf, Tasmin Ara Sultana, A. H. M. Mahbub Latif and Abul Hasnat

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.