Esomeprazole 40mg Capsules are Bioequivalent when Administered Intact or as the Contents Mixed with Applesauce*

Abstract

This study was conducted to determine whether administration of the contents of an open capsule of esomeprazole (enteric-coated pellets) 40mg with applesauce is bioequivalent to administration of an intact capsule in healthy volunteers. 45 adult male and female volunteers participated in this randomised, single-dose, nonblinded, two-way crossover study conducted at a single centre. 41 volunteers completed the trial. Time to maximum plasma concentration (Cmax) for esomeprazole (tmax) was approximately 2.4 hours and elimination half-life (t1/2) was approximately 0.9 hours by either mode of administration. The ratios of the geometric means for Cmax and area under the plasma concentration-time curve (AUC) for capsule contents with applesauce relative to intact capsule were 0.93 (90% confidence interval [CI]: 0.86 to 1.01) and 0.99 (90% CI: 0.94 to 1.04), respectively. The finding that the 90% CIs were within 0.80 to 1.25 for both parameters indicates bioequivalence. Esomeprazole was well tolerated by the study group irrespective of mode of administration. Esomeprazole is bioequivalent when administered either as an intact capsule or as the contents of a capsule mixed with applesauce in healthy volunteers. This latter alternative mode of administration may provide benefits to patients who have difficulty swallowing.