/ CompletedNot Applicable 依折麦布辛伐他汀片(10mg/20mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of ezetimibe-simvastatin tablets (10 mg/20 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择N.V.Organon(The Netherlands)为持证商的依折麦布辛伐他汀片(商品名:葆至能,规格:依折麦布10mg,辛伐他汀20mg)为参比制剂,对浙江亚瑟医药有限公司提供的受试制剂依折麦布辛伐他汀片(规格:依折麦布10mg,辛伐他汀20mg) 进行空腹和餐后给药人体生物等效性试验,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂依折麦布辛伐他汀片(规格:依折麦布10mg,辛伐他汀20mg)和参比制剂依折麦布辛伐他汀片(商品名:葆至能,规格:依折麦布10mg,辛伐他汀20mg)的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, the ezetimibe simvastatin tablets (trade name: Baozhineng, specification: ezetimibe 10mg, simvastatin 20mg) of N.V.Organon (The Netherlands) as the licensee were selected as the reference preparation, and the test preparation ezetimibe simvastatin tablets (specification: ezetimibe 10mg, simvastatin 20mg) provided by Zhejiang Arthur Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation ezetimibe simvastatin tablets (specification: ezetimibe 10mg, simvastatin 20mg) and the reference preparation ezetimibe simvastatin tablets (trade name: Baozhineng, specification: ezetimibe 10mg, simvastatin 20mg) by healthy volunteers.
/ CompletedNot Applicable 依西美坦片(25mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, four-period, fully repeated crossover bioequivalence study of exemestane tablets (25 mg) in healthy Chinese subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择Pfizer Italia s.r.l.为持证商的依西美坦片(商品名:阿诺新®,规格:25mg)为参比制剂,对连云港杰瑞药业有限公司生产、浙江亚瑟医药有限公司持证的受试制剂依西美坦片(规格:25mg)进行空腹和餐后给药条件下的人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂依西美坦片(规格:25mg)和参比制剂依西美坦片(商品名:阿诺新®,规格:25mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, exemestane tablets (trade name: Arnoxin®, specification: 25mg) with Pfizer Italia s.r.l. as the licensee were selected as the reference preparation, and the test preparation exemestane tablets (specification: 25mg) produced by Lianyungang Jerry Pharmaceutical Co., Ltd. and licensed by Zhejiang Arthur Pharmaceutical Co., Ltd. were tested in human body under fasting and postprandial administration conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation exemestane tablets (specification: 25mg) and the reference preparation exemestane tablets (trade name: Arnoxin®, specification: 25mg) by healthy subjects.
100 Clinical Results associated with Zhejiang Arthur Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang Arthur Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang Arthur Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang Arthur Pharmaceutical Co., Ltd.