Lansoprazole/Sodium Bicarbonate

Primary Objective: To investigate the pharmacokinetic (PK) and drug-promoting (PD) characteristics of the investigational drug HKG-456 (lansoprazole 30 mg/sodium bicarbonate 1680 mg, certified by Hainan Yuanying Pharmaceutical Technology Co., Ltd.) and the control drug lansoprazole enteric-coated capsules (Dacoprolone, 30 mg, certified by Tianjin Takeda Pharmaceutical Co., Ltd.) in healthy participants under fasting conditions with single and multiple oral administrations. Secondary Objective: To evaluate the safety of HKG-456 with single and multiple oral administrations in healthy Chinese participants, and to assess the palatability of HKG-456 in healthy adult Chinese participants, providing evidence for the taste profile of HKG-456.

Healthy subjects were used as test subjects, lansoprazole sodium bicarbonate dry suspension (containing 15 mg lansoprazole and 1680 mg sodium bicarbonate per bag) was used as the test preparation, and lansoprazole enteric-coated capsules (Takepron®, 15 mg) was used as the reference preparation. A single-center, randomized, open, two-preparation, two-period, two-sequence, crossover, single and multiple dosing test design was used to conduct a pharmacokinetic and pharmacodynamic comparison test of the two preparations and a test on 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.