[Translation] Randomized, open, single-dose, two preparations, cross-controlled design, evaluation of single oral administration of test preparation aspirin enteric-coated tablets and reference preparation aspirin enteric-coated tablets (trade name: Bayaspirin®/bayaspirin®) in fasting and postprandial states Ling®) formal bioequivalence trial in Chinese healthy subjects
主要研究目的:以浙江易泽达医药科技有限公司提供的阿司匹林肠溶片受试制剂,按生物等效性试验的有关规定,与Bayer HealthCare Manufacturing S.r.l.生产的阿司匹林肠溶片(参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] The main purpose of the research is to compare the test preparation of aspirin enteric-coated tablets provided by Zhejiang Eizeda Pharmaceutical Technology Co., Ltd. with the aspirin enteric-coated tablets (reference preparation) produced by Bayer HealthCare Manufacturing S.r.l. according to the relevant regulations of bioequivalence test The absorption speed and degree of absorption in healthy human body, and the human bioequivalence of the two preparations were investigated.