Esomeprazole Magnesium/Sodium Bicarbonate

Healthy subjects were used as test subjects, esomeprazole magnesium sodium bicarbonate dry suspension (I) (specification: each bag contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1680 mg of sodium bicarbonate) as the test preparation, and esomeprazole sodium bicarbonate capsules (specification: each capsule contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1100 mg of sodium bicarbonate) as the reference preparation. Single and multiple dosing test designs were used to conduct pharmacokinetic and pharmacodynamic comparison tests of the two preparations and the effect of food on the PK parameters of the test preparation: 1. Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple dosing; 2. Compare the pharmacodynamic parameters of the test preparation and the reference preparation after single and multiple dosing; 3. Evaluate the effect of food on the pharmacokinetic parameters of the test preparation; 4. Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects

To evaluate the pharmacokinetics and pharmacodynamics bioequivalence, as well as the safety and tolerability of the test formulation XY066 produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the original reference formulation in healthy adult subjects in China.