[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of ilaprazole enteric-coated tablets (5 mg) in Chinese healthy volunteers under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择丽珠集团丽珠制药厂为持证商的艾普拉唑肠溶片(商品名:壹丽安,规格:5mg)为参比制剂,对四川科伦药业股份有限公司生产并提供的受试制剂艾普拉唑肠溶片(规格:5mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂艾普拉唑肠溶片(规格:5mg)和参比制剂艾普拉唑肠溶片(商品名:壹丽安,规格:5mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5mg) of which Livzon Pharmaceutical Factory of Livzon Group is the licensee was selected as the reference preparation, and the test preparation ilaprazole enteric-coated tablets (specification: 5mg) produced and provided by Sichuan Kelun Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation ilaprazole enteric-coated tablets (specification: 5mg) and the reference preparation ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5mg) to healthy subjects.