[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of selexipag tablets in Chinese healthy volunteers under fasting and fed conditions
研究健康受试者空腹及餐后单次口服受试制剂司来帕格片(江苏博新医药科技有限公司,规格:0.2mg)与参比制剂司来帕格片(商品名:优拓比 ®,规格:0.2mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后状态下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] To study whether there are differences in the extent and rate of absorption between the test preparation Selexipag tablets (Jiangsu Boxin Pharmaceutical Technology Co., Ltd., specification: 0.2 mg) and the reference preparation Selexipag tablets (trade name: Utopi®, specification: 0.2 mg) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.