Jinan Mingxin Pharmaceutical Co. Ltd.

This clinical trial intends to use metformin vildagliptin tablets (II) (Eucreas®/Eucreas®, specifications: 850 mg/50 mg) licensed by Novartis Pharma Schweiz AG and produced by Novartis Pharma Produktions GmbH as the reference preparation, and metformin vildagliptin tablets (II) (specifications: 850 mg/50 mg) produced by Jinan Mingxin Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in healthy Chinese adults.

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Vonoprazan fumarate tablets (specification: 20 mg, manufacturer: Jinan Mingxin Pharmaceutical Co., Ltd.) and the reference preparation Vonoprazan fumarate tablets (specification: 20 mg, licensee: Takeda Pharmaceutical Company Limited, trade name: Walker®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation Vonoprazan fumarate tablets and the reference preparation Vonoprazan fumarate tablets in healthy subjects.

Main study objectives To study the pharmacokinetics of the test preparation vildagliptin tablets (specification: 50 mg, produced by Jinan Mingxin Pharmaceutical Co., Ltd.) and the reference preparation vildagliptin tablets (trade name: Galvus®, specification: 50 mg, produced by Novartis) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting/fed state. Secondary study objectives To observe the safety of the test preparation vildagliptin tablets and the reference preparation vildagliptin tablets (Galvus®) in healthy adult subjects.