[Translation] A single-center, open-label, randomized, single-dose, two-formulation, two-sequence, four-cycle, fully repeated bioequivalence study of ilaprazole enteric-coated tablets in healthy subjects under fasting and fed conditions
主要目的:比较空腹和餐后给药条件下,山东朗诺制药有限公司研制的艾普拉唑肠溶片(5mg)与丽珠集团丽珠制药厂持证的艾普拉唑肠溶片(5mg,商品名:壹丽安)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹和餐后给药条件下,山东朗诺制药有限公司研制的艾普拉唑肠溶片(5mg)与丽珠集团丽珠制药厂持证的艾普拉唑肠溶片(5mg,商品名:壹丽安)在健康成年人群中的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and rate of ilaprazole enteric-coated tablets (5 mg) developed by Shandong Langnuo Pharmaceutical Co., Ltd. and ilaprazole enteric-coated tablets (5 mg, trade name: Yilian) certified by Livzon Pharmaceutical Factory of Livzon Group in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of ilaprazole enteric-coated tablets (5 mg) developed by Shandong Langnuo Pharmaceutical Co., Ltd. and ilaprazole enteric-coated tablets (5 mg, trade name: Yilian) certified by Livzon Pharmaceutical Factory of Livzon Group in healthy adults under fasting and postprandial administration conditions.