Hainan Guangshengyu Pharmaceutical Co., Ltd.

According to the relevant provisions of bioequivalence test, Takeda Pharmaceutical Company Limited was selected as the reference preparation for the Vonoprazan Fumarate Tablets (trade name: Vocinti, specification: 20mg), which was licensed by Jiangsu Chengkang Pharmaceutical Co., Ltd. and provided by Hainan Guangshengyu Pharmaceutical Co., Ltd., to conduct human bioequivalence tests on fasting and postprandial administration of the test preparation Vonoprazan Fumarate Tablets (Specification: 20mg), to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. At the same time, the safety of the test preparation and the reference preparation after oral administration was observed in healthy subjects.

According to the relevant provisions of bioequivalence tests, acetylcysteine granules (trade name: Fulushi®, specification: 0.2g) licensed by Hainan Zanbang Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation acetylcysteine granules (specification: 0.2g) licensed by Hainan Guangshengyu Pharmaceutical Co., Ltd. and produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. were subjected to human bioequivalence tests on fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated. At the same time, the safety of the test preparation and the reference preparation after oral administration was observed in healthy subjects.

Main purpose: To evaluate the relative bioavailability and bioequivalence of omeprazole sodium bicarbonate capsules provided by Hainan Guangshengyu Pharmaceutical Co., Ltd. as the test preparation and omeprazole sodium bicarbonate capsules certified by Salix Pharmaceuticals Inc. as the reference preparation.