Shaanxi Tianyu Pharmaceutical Co., Ltd.

Main purpose of the study: According to the relevant provisions of bioequivalence tests, Takeda Pharmaceutical Company Limited was selected as the reference preparation for the vonoprazan fumarate tablets (trade name: Vocinti (Walker), specification: 20mg) as the licensee, and the test preparation vonoprazan fumarate tablets (specification: 20mg) (manufacturer: Sichuan Kelun Pharmaceutical Co., Ltd., marketing authorization holder: Shaanxi Tianyu Pharmaceutical Co., Ltd.) was subjected to human bioequivalence tests under fasting and postprandial conditions, to compare whether the absorption rate and degree of the drug in the test preparation in healthy subjects are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation vonoprazan fumarate tablets (specification: 20mg) and the reference preparation vonoprazan fumarate tablets (trade name: Vocinti (Walker), specification: 20mg) to healthy Chinese subjects.

Primary objective: To observe the pharmacokinetic characteristics of the test preparation montelukast sodium granules (specification: 0.5g: 4mg (in terms of montelukast); manufacturer: Xi'an Yuanda Detian Pharmaceutical Co., Ltd.; marketing authorization holder: Shaanxi Tianyu Pharmaceutical Co., Ltd.) and the reference preparation montelukast sodium granules (trade name: Singulair; specification: 0.5g: 4mg (in terms of montelukast); manufacturer: Patheon Manufacturing Services LLC; licensee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) after a single oral administration in the fasting/fed state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. Secondary objective: To observe the safety of the test preparation montelukast sodium granules and the reference preparation montelukast sodium granules (Singulair) in healthy Chinese subjects.