[Translation] A single-dose, randomized, open-label, crossover, fasting and fed bioequivalence study of lansoprazole enteric-coated capsules in healthy subjects
主要目的:以成都欣捷高新技术开发股份有限公司的兰索拉唑肠溶胶囊(规格:30mg)为受试制剂,以Takeda Pharmaceutical Co., Ltd.的兰索拉唑肠溶胶囊(商品名:Takepron®,规格:30mg)为参比制剂,按生物等效性试验的有关规定,考察受试制剂和参比制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Lansoprazole enteric-coated capsules (specification: 30 mg) of Chengdu Xinjie High-tech Development Co., Ltd. were used as the test preparation, and Lansoprazole enteric-coated capsules (trade name: Takepron®, specification: 30 mg) of Takeda Pharmaceutical Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the test preparation and the reference preparation in healthy subjects was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.