[Translation] A formal trial of randomized, open-label, single-dose, two-formulation, crossover design to evaluate the bioequivalence of a single oral dose of the test formulation enteric-coated aspirin tablets and the reference formulation enteric-coated aspirin tablets (trade name: Bayaspirin®/Bayaspirin®) in healthy Chinese subjects under fasting and fed conditions
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 study is to compare the absorption rate and extent of enteric-coated aspirin tablets provided by Zhejiang Yizeda Pharmaceutical Technology Co., Ltd. with that of enteric-coated aspirin tablets (reference preparation) produced by Bayer HealthCare Manufacturing S.r.l. in healthy humans according to the relevant provisions of the bioequivalence test, and to investigate the bioequivalence of the two preparations in humans.