Bioequivalence Evaluation of Two Esomeprazole 20 mg Capsule Formulations in Healthy Male Bangladeshi Volunteers
- *Corresponding Author:
- Dr. Abul Hasnat
Professor, Department of Clinical Pharmacy and Pharmacology
Faculty of Pharmacy, University of Dhaka
Dhaka - 1000, Bangladesh
E-mail: [email protected]
Received Date: October 09, 2010; Accepted Date: March 28, 2011; Published Date: August 03, 2011
Citation: Islam MS, Akter N, Shohag H, Ullah A, Al Maruf A, et al. (2011) Bioequivalence Evaluation of Two Esomeprazole 20 mg Capsule Formulations in Healthy Male Bangladeshi Volunteers. J Bioequiv Availab 3: 139-143. doi: 10.4172/jbb.1000074
Copyright: © 2011 Islam MS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.