/ CompletedNot Applicable 非奈利酮片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of finerenone tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以天津汉瑞药业有限公司持证的非奈利酮片(10mg)为受试制剂,Bayer AG持证的非奈利酮片(商品名:可申达,规格:10mg)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 purpose: This study used the phenarenic acid tablets (10 mg) certified by Tianjin Hanrui Pharmaceutical Co., Ltd. as the test preparation and the phenarenic acid tablets (trade name: Keshenda, specification: 10 mg) certified by Bayer AG 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 purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Tianjin Hanrui Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Tianjin Hanrui Pharmaceutical Co., Ltd.
100 Deals associated with Tianjin Hanrui Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Tianjin Hanrui Pharmaceutical Co., Ltd.