[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of rivaroxaban orodisintegrating tablets (15 mg) in healthy Chinese subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择持证商为バイエル薬品株式会社的利伐沙班口崩片(商品名:Xarelto®,规格:15mg)为参比制剂,对合肥恩瑞特药业有限公司生产并提供的受试制剂利伐沙班口崩片(规格:15mg)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:观察健康志愿受试者口服受试制剂利伐沙班口崩片(规格:15mg)和参比制剂利伐沙班口崩片(商品名:Xarelto®,规格:15mg)的安全性。
[Translation] Main purpose of the study: According to the relevant provisions of bioequivalence tests, the licensee of Rivaroxaban orodisintegrating tablets (trade name: Xarelto®, specification: 15 mg) was selected as the reference preparation, and the test preparation Rivaroxaban orodisintegrating tablets (specification: 15 mg) produced and provided by Hefei Enrui Pharmaceutical Co., Ltd. were subjected to human bioequivalence tests 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 purpose of the study: To observe the safety of oral administration of the test preparation Rivaroxaban orodisintegrating tablets (specification: 15 mg) and the reference preparation Rivaroxaban orodisintegrating tablets (trade name: Xarelto®, specification: 15 mg) by healthy volunteers.