Hebei Puzhou Pharmaceutical Co., Ltd.

Main study objectives: To conduct a bioequivalence study on Chinese healthy subjects by taking a single oral dose of Rabeprazole Sodium Enteric-coated Tablets (Rabeprazole Sodium Enteric-coated Tablets, test preparation T, developed by Hebei Puzhou Pharmaceutical Co., Ltd., produced by Shijiazhuang Longze Pharmaceutical Co., Ltd., specification: 20 mg/tablet) and Rabeprazole Sodium Enteric-coated Tablets (Rabeprazole Sodium Enteric-coated Tablets, reference preparation R, produced by Eisai (China) Pharmaceutical Co., Ltd., trade name: Pariet®, specification: 20 mg/tablet) in the fasting/postprandial state, to study the absorption rate and extent of the test preparation and the reference preparation in the human body in the fasting/postprandial state, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: To observe the safety of the test preparation Rabeprazole Sodium Enteric-coated Tablets and the reference preparation Rabeprazole Sodium Enteric-coated Tablets (Pariet®/Polite®) in healthy subjects.

After a single oral dose of levamlodipine besylate tablets (test preparation T, developed by Hebei Puzhou Pharmaceutical Co., Ltd., produced by Shijiazhuang Longze Pharmaceutical Co., Ltd., specification: 5 mg/tablet) and amlodipine besylate tablets (reference preparation R, produced by Pfizer Pharmaceuticals Co., Ltd., trade name: Norvasc®, specification: 10 mg/tablet) was administered to healthy subjects in the fasting/postprandial state, the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions were investigated to evaluate whether the test preparation and the reference preparation were bioequivalent. Secondary objective: To observe the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy subjects.