Jinan Gaohua Pharmaceutical Factory

Vonoprazan fumarate tablets (specification: 20 mg) provided by Jinan Gaohua Pharmaceutical Co., Ltd. were used as the test preparation, and Vonoprazan fumarate tablets (trade name: Vocinti (Walker); specification: 20 mg) certified by Takeda Pharmaceutical Company Limited were used as the reference preparation. The bioequivalence of the test preparation and the reference preparation under fasting and fed conditions was compared.

In this study, levamlodipine besylate tablets (specification: 5 mg) produced by Jinan Gaohua Pharmaceutical Co., Ltd. were used as the test preparation, and amlodipine besylate tablets (trade name: Norvasc®; specification: 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions were investigated to evaluate the bioequivalence of the two preparations.

The main purpose of the study is to use Sitagliptin Phosphate Tablets (Specification: 100 mg) of Jinan Gaohua Pharmaceutical Co., Ltd. as the test preparation and Sitagliptin Phosphate Tablets (Specification: 100 mg, Trade Name: JANUVIA®) of Merck Sharp & Dohme B.V. as the reference preparation, and investigate the bioequivalence of the two preparations in healthy subjects according to the relevant provisions of the bioequivalence test. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy subjects.