Shandong Changli Pharmaceutical Industry Co. Ltd.

The main purpose of the study was to evaluate the bioequivalence of omeprazole sodium bicarbonate capsules (specifications: omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by Beijing Biopharma Co., Ltd. and omeprazole sodium bicarbonate capsules (trade name: ZEGERID®, specifications: omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by SALIX PHARMACEUTICALS in healthy subjects under fasting conditions. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation omeprazole sodium bicarbonate capsules in healthy subjects.

The primary study objective is to evaluate the bioequivalence of the test formulation and the reference formulation after a single oral administration on an empty stomach in healthy Chinese adult subjects. The secondary study objective is to evaluate the safety of the test formulation and the reference formulation after a single oral administration on an empty stomach in healthy Chinese adult subjects.

To study the time course of blood drug concentration of omeprazole sodium bicarbonate capsules (omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by Beijing Biopharma Co., Ltd. and omeprazole sodium bicarbonate capsules (ZEGERID (omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by Santarus) in the fasting state, and the pharmacokinetics in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations after fasting oral administration