依利格鲁司他胶囊在中国成年健康志愿者中的一项随机、开放、餐后单次给药、两制剂、两周期、双交叉的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of iliglustat capsules in healthy adult Chinese 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] Primary objective: To study the pharmacokinetics of the test formulation of iliglustat capsules (84 mg, developed by Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.) and the reference formulation (trade name: Cerdelga, 84 mg, Genzyme Ireland Ltd.) in healthy Chinese volunteers after a single oral dose after a meal, and to evaluate the bioequivalence between the two formulations. Secondary objective: To observe the safety of a single dose of 84 mg of the test formulation iliglustat capsules and 84 mg of the reference formulation iliglustat capsules in healthy Chinese volunteers.
/ CompletedNot Applicable 依利格鲁司他胶囊在中国成年健康志愿者中空腹和餐后状态下随机开放单剂量两周期双交叉的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of iliglustat capsules in Chinese healthy adult volunteers under fasting and fed conditions
主要目的:研究空腹/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] Primary objective: To study the pharmacokinetics of the test formulation of iliglustat capsules (84 mg, developed by Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.) and the reference formulation (trade name: Cerdelga, 84 mg, Genzyme Ireland Ltd.) in healthy Chinese volunteers after a single oral administration on an empty stomach or after a meal, and to evaluate the bioequivalence between the two formulations.
Secondary objective: To observe the safety of a single oral administration of 84 mg of the test formulation iliglustat capsules and 84 mg of the reference formulation iliglustat capsules in healthy Chinese volunteers.
100 Clinical Results associated with Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.
100 Deals associated with Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Beijing Kailai Tiancheng Pharmaceutical Technology Co., Ltd.