Tasmin Ara Sultana
Bangladesh
Research Article
Bioequivalence Evaluation of Two Esomeprazole 20 mg Capsule
Formulations in Healthy Male Bangladeshi Volunteers
Author(s): Mohammad Safiqul Islam, Nahia Akter, Hasanuzzaman Shohag, Ashik Ullah, Abdullah Al Maruf, Tasmin Ara Sultana, A. H. M. Mahbub Latif and Abul HasnatMohammad 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-∞.. View More»
DOI:
10.4172/jbb.1000074