Bioequivalence Study of Esomeprazole in Healthy Adults, Human Subjects, Under Fasting Conditions

Abstract

This is an open label, randomized, balanced, two treatment, two period, two-sequence, single dose, crossover bioequivalence study in twelve (12) healthy adults, human subjects, under fasting conditions. In each treatment period, subjects received a single dose of esomeprazole 40 mg capsule. Treatment periods separated by a washout period of at least 05 days. The bioequivalence of a single capsule formulation of esomeprazole 40 mg given individually assessed by the geometric mean ratios of the area under the plasma concentration time curve (AUC) and observed maximum plasma concentration (Cmax). ANOVA model performed on an untransformed and a natural log-transformed AUC0-t, AUC0-∞ and Cmax taking into account - sequence, subject (sequence), period and treatment as variables. 90% Confidence interval for the ratio of the geometric least square means of natural log transformed Cmax, AUC0-t and AUC0-∞ of Test and Reference formulations are within 80.0% to 125.0%, hence bioequivalence is established.