[Translation] A randomized, open-label, postprandial single-dose, two-dose, two-cycle, double-crossover bioequivalence study of eligllustat capsules in Chinese adult healthy volunteers
主要目的:研究餐后单次口服依利格鲁司他胶囊受试制剂(84mg,北京凯莱天成医药科技有限公司研制)和参比制剂(商品名:Cerdelga,84mg,Genzyme Ireland Ltd.)在中国健康人体的药代动力学,评价两种制剂间的生物等效性。 次要目的:观察中国健康志愿者单次服用84 mg受试制剂依利格鲁司他胶囊和84 mg参比制剂依利格鲁司他胶囊的安全性。
[Translation] Main purpose: To study the test preparation (84mg, developed by Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.) and the reference preparation (trade name: Cerdelga, 84mg, Genzyme Ireland Ltd.) in China Pharmacokinetics in healthy humans, evaluating bioequivalence between two formulations. Secondary objective: To observe the safety of Chinese healthy volunteers taking a single dose of 84 mg test preparation eliglustat capsules and 84 mg reference preparation eliglustat capsules.