Yabao Pharmaceutical Co. Ltd. Beijing

The test preparation was ezetimibe tablets (specification: 10 mg) produced by Beijing Yabao Biopharmaceutical Co., Ltd., and the reference preparation was ezetimibe tablets (Ezetrol/Yishichun®, specification: 10 mg) marketed by MSD PHARMA (Singapore) Pte. Ltd. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Main research purpose: Using sitagliptin metformin extended-release tablets produced by Beijing Yabao Biopharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the relative bioavailability in healthy humans was compared with sitagliptin metformin extended-release tablets produced by AIAC International Pharma, LLC (reference preparation, trade name: Janumet® XR, licensee: Merck Sharp & Dohme Corp.), and the human bioequivalence of the two preparations was investigated. Secondary research purpose: To observe the safety of the test preparation and reference preparation (trade name: Janumet® XR) of sitagliptin metformin extended-release tablets in healthy subjects.

The main purpose of the study is to investigate the pharmacokinetic characteristics of acotiamide hydrochloride tablets (test preparation T, specification: 100 mg) produced by Beijing Yabao Biopharmaceutical Co., Ltd. and acotiamide hydrochloride tablets (reference preparation R, trade name: Acofide®, specification: 100 mg) produced by Japan Sawari Shinyaku Kogyo Co., Ltd. under the same conditions, and to evaluate the bioequivalence of the two preparations to provide a basis for the registration application of the test preparation. The secondary purpose of the study is to observe the safety of acotiamide hydrochloride tablets (specification: 100 mg) and acotiamide hydrochloride tablets (trade name: Acofide®, specification: 100 mg) of a single oral administration of 100 mg of the test preparation in healthy subjects under fasting and postprandial conditions.