Hefei Chuangxin Medicine Technology Co., Ltd.

Main research purpose: Use minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) produced by Aisuo Biotech Co., Ltd. as the reference preparation, and use minodronic acid provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. The tablet (specification: 1 mg/tablet) is the test preparation. A randomized, open-label, single-dose, four-cycle, fully repeated crossover design was adopted to compare the effects of minodronic acid after subjects took the test preparation and the reference preparation in the fasting state. The absorption rate and extent were evaluated to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting state. Secondary research purpose: To evaluate the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.

The main purpose of the study is to use the vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) of the licensee TAKEDA PHARMACEUTICALS USA INC as the reference preparation and the vortioxetine hydrobromide tablets (specification: 20 mg) provided by Hefei Innovation Pharmaceutical Technology Co., Ltd. as the test preparation. A randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. Secondary purpose of the study: To evaluate the safety of the oral test preparation vortioxetine hydrobromide tablets (specification: 20 mg) and the reference preparation vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) in healthy Chinese subjects.

Main purpose of the study: According to the relevant provisions of bioequivalence tests, vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) produced by TAKEDA PHARMACEUTICALS USA were selected as the reference preparation. The test preparation vortioxetine hydrobromide tablets (specification: 20 mg) produced by Hefei Innovation Pharmaceutical Technology Co., Ltd. were used for fasting and postprandial human bioequivalence preliminary tests. The absorption rate and degree of the drug in the test preparation and the reference preparation were compared, and the intra-individual variability of key pharmacokinetic parameters was investigated to provide a basis for the determination of the sample size of the formal test and the optimization of the test plan. Secondary purpose of the study: To evaluate the safety of the oral test preparation vortioxetine hydrobromide tablets (specification: 20 mg) and the reference preparation vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) in healthy Chinese subjects.