[Translation] A single-center, randomized, open-label, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the bioequivalence of the test product, Rivaroxaban Tablets (strength: 20 mg), and the reference product, Xarelto® (strength: 20 mg), in healthy adult subjects in the fed state
主要研究目的:研究空腹状态下单次口服受试制剂利伐沙班片(规格:20 mg,浙江金华康恩贝生物制药有限公司生产)与参比制剂利伐沙班片(Xarelto®,规格:20 mg,Janssen Pharmaceuticals Inc生产)在健康受试者体内的药代动力学,评价餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂利伐沙班片(规格:20 mg)和参比制剂利伐沙班片(Xarelto®,规格:20 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation rivaroxaban tablets (specification: 20 mg, produced by Zhejiang Jinhua Kangenbei Biopharmaceutical Co., Ltd.) and the reference preparation rivaroxaban tablets (Xarelto®, specification: 20 mg, produced by Janssen Pharmaceuticals Inc) in healthy subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state.
Secondary purpose of the study is to evaluate the safety of the test preparation rivaroxaban tablets (specification: 20 mg) and the reference preparation rivaroxaban tablets (Xarelto®, specification: 20 mg) in healthy subjects.