Shouguang Fukang Pharmaceutical Co. Ltd.

Primary study objectives: To study the pharmacokinetic characteristics of the test preparation sitagliptin metformin extended-release tablets (specifications: 50 mg/500 mg, produced by Shouguang Fukang Pharmaceutical Co., Ltd.) and the reference preparation sitagliptin metformin extended-release tablets (Janumet® XR, specifications: 50 mg/500 mg, produced by Merck Sharp and Dohme Corp) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives: To study the safety of the test preparation sitagliptin metformin extended-release tablets (specifications: 50 mg/500 mg) and the reference preparation sitagliptin metformin extended-release tablets (Janumet® XR, specifications: 50 mg/500 mg) in healthy participants.

Primary objective: To study the pharmacokinetics of the test preparation Vonoprazan fumarate tablets (specification: 20 mg, Shouguang Fukang Pharmaceutical Co., Ltd.) and the reference preparation Vonoprazan fumarate tablets (trade name: Walker®, specification: 20 mg, Takeda Pharmaceutical Company Limited) in healthy adult subjects after a single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation (T) Vonoprazan fumarate tablets and the reference preparation (R) Vonoprazan fumarate tablets (Walker®) in healthy subjects after a single oral administration in fasting and fed state.

The aim of this study was to investigate the pharmacokinetic characteristics of metformin empagliflozin tablets (500 mg/5 mg) developed and produced by Shouguang Fukang Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. The metformin empagliflozin tablets (Synjardy®, 500 mg/5 mg) produced by Boehringer Ingelheim Promeco S.A. de C.V. were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.