Bioequivalence of Omeprazole Enteric-coated Capsules in Healthy Volunteers

OBJECTIVE:To compare the bioequivalence of 2 kinds of Omeprazole enteric-coated capsules. METHODS: A single dose of Omeprazole enteric-coated capsules was given to 18 healthy volunteers by randomized crossover method, and the plasma concentrations of omeprazole were determined by HPLC. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS: The plasma concentration-time curve of two preparations fitted to one-compartment model. The pharmacokinetic parameters of test preparation vs. reference preparation were as follows: Cmax(1.69±1.00) μg·mL-1 vs. (1.71±1.02) μg·mL-1; tmax(3.22±1.11)h vs. (3.06±1.00)h; AUC0～24(8.42±4.38) μg·h·mL-1 vs. (8.87±5.32) μg·h·mL-1; AUC0～∞(10.35±5.01) μg·h·mL-1 vs. (10.81±5.86) μg·h·mL-1. The relative bioavailability of Omeprazole enteric-coated capsules was(94.93±14.54)%.CONCLUSION:2 kinds of Omeprazole enteric-coated capsules are bioequivalent.