/ CompletedNot Applicable 骨化三醇软胶囊在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of calcitriol soft capsules in healthy volunteers under fasting/fed conditions
主要研究目的:本研究以珠海健福制药有限公司持证的骨化三醇软胶囊(规格:0.25μg)为受试制剂,Atnahs Pharma UK Limited 持证的骨化三醇胶丸(商品名:罗盖全®,规格:0.25μg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study uses the calcitriol soft capsules (specification: 0.25μg) certified by Zhuhai Jianfu Pharmaceutical Co., Ltd. as the test preparation and the calcitriol capsules (trade name: Luogaiquan®, specification: 0.25μg) certified by Atnahs Pharma UK Limited as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
/ Not yet recruitingNot Applicable 罗沙司他胶囊在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of roxadustat capsules in Chinese healthy volunteers under fasting and fed conditions
主要目的:观察罗沙司他胶囊在中国健康受试者中单次口服给药后的罗沙司他体内动力学过程,估算相应的药代动力学参数,并以珐博进(中国)医药技术开发有限公司持证的罗沙司他胶囊(规格:50mg,爱瑞卓®)为参比制剂,进行生物等效性评价。
次要目的:观察罗沙司他胶囊受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective: To observe the in vivo kinetics of roxadustat after a single oral administration of roxadustat capsules in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and conduct bioequivalence evaluation using roxadustat capsules (specification: 50 mg, Aerezo®) certified by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. as the reference preparation.
Secondary objective: To observe the safety of the test preparation and reference preparation of roxadustat capsules in healthy humans.
100 Clinical Results associated with Zhuhai Jianfu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhuhai Jianfu Pharmaceutical Co., Ltd.
100 Deals associated with Zhuhai Jianfu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhuhai Jianfu Pharmaceutical Co., Ltd.