Hubei Shubang Pharmaceutical Co Ltd.

A single-center, randomized, open-label, two-preparation, two-cycle crossover, and single-dose dosing design was adopted to compare Fudosteine tablets provided by Hubei Shubon Pharmaceutical Co., Ltd. (Specifications: 0.2 g) and Tabe Mitsubishi Co., Ltd.’s certified fudosteine tablets (specification: 0.2 g, trade name: Cleanal®) in the degree and rate of absorption in Chinese healthy people, and to evaluate the differences in the absorption rate of Hubei Shubon Pharmaceuticals Safety of Fodorsteine Tablets offered by Ltd.

Main study purpose Healthy subjects were given a single oral dose of the test preparation Nimesulide dispersible tablets produced by Hubei Shubang Pharmaceutical Co., Ltd. or the reference preparation Nimesulide tablets produced by Helsinn Birex Pharmaceutical Ltd. in the fasting or postprandial state, and the pharmacokinetic parameters of the test preparation and the reference preparation in the healthy subjects were investigated in the fasting and postprandial state, respectively, to evaluate the bioequivalence of the two preparations. Secondary study purpose To investigate the safety of the test preparation and the reference preparation of nimesulide in healthy subjects.

Primary objective: To evaluate the bioequivalence of lafutidine tablets (specification: 5 mg/tablet) of Hubei Shubang Pharmaceutical Co., Ltd. and lafutidine tablets (specification: 5 mg/tablet) of Dapeng Pharmaceutical Industry Co., Ltd. in healthy adult subjects after single oral administration in fasting and fed state. Secondary objective: To evaluate the safety of lafutidine tablets in healthy adult subjects.