[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test product, Selexipag tablets (strength: 0.4 mg), and the reference product, Uptravi® (strength: 0.4 mg), in healthy adult participants in the fasting and fed states.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂司来帕格片(规格:0.4 mg,辰欣药业股份有限公司生产)与参比制剂司来帕格片(Uptravi®,规格:0.4 mg,Janssen Pharmaceutica NV生产)在健康参与者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂司来帕格片(规格:0.4 mg)和参比制剂司来帕格片(Uptravi®,规格:0.4 mg)在健康参与者中的安全性。
[Translation] Primary study objectives: To study the pharmacokinetics of a single oral dose of the test preparation Selexipag tablets (0.4 mg, manufactured by Chenxin Pharmaceutical Co., Ltd.) and the reference preparation Selexipag tablets (Uptravi®, 0.4 mg, manufactured by Janssen Pharmaceutica NV) in healthy participants in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives: To evaluate the safety of the test preparation Selexipag tablets (0.4 mg) and the reference preparation Selexipag tablets (Uptravi®, 0.4 mg) in healthy participants.