利伐沙班片健康受试者空腹/餐后单次口服给药、随机、开放、两序列、四周期、完全重复、交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, fully repeated, crossover bioequivalence study of rivaroxaban tablets in healthy subjects after single oral administration on an empty stomach or after a meal
主要目的:以武汉健民中维医药有限公司生产的利伐沙班片(10 mg)为受试制剂,Bayer AG公司生产的利伐沙班片(10 mg)为参比制剂,比较两制剂在健康受试者体内的药代动力学参数,评价两制剂在空腹和餐后两种状态下的人体生物等效性。
次要目的:观察受试制剂利伐沙班片和参比制剂利伐沙班片在健康受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic parameters of the two preparations in healthy subjects, and to evaluate the bioequivalence of the two preparations in both fasting and postprandial states, using rivaroxaban tablets (10 mg) produced by Wuhan Jianmin Zhongwei Pharmaceutical Co., Ltd. as the test preparation and rivaroxaban tablets (10 mg) produced by Bayer AG as the reference preparation.
Secondary objective: To observe the safety of the test preparation rivaroxaban tablets and the reference preparation rivaroxaban tablets in healthy subjects.
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