[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of rivaroxaban tablets in healthy Chinese adult participants under fasting and fed conditions
主要研究目的:考察单次口服(空腹/餐后)15mg受试制剂利伐沙班片和参比制剂利伐沙班片,在中国成年健康参与者体内的药代动力学特征,评估空腹与餐后条件下分别口服两种制剂的生物等效性。 次要研究目的:评价受试制剂和参比制剂单次口服15mg(空腹/餐后)在中国成年健康参与者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose (fasting/after meals) of 15 mg of the test preparation rivaroxaban tablets and the reference preparation rivaroxaban tablets in healthy adult Chinese participants, and to evaluate the bioequivalence of the two preparations under fasting and after meals conditions. The secondary purpose of the study is to evaluate the safety of a single oral dose of 15 mg (fasting/after meals) of the test preparation and the reference preparation in healthy adult Chinese participants.