Target- |
Mechanism- |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date01 Jan 1952 |
/ CompletedNot Applicable 卡托普利片在健康受试者中随机、开放、单剂量、双周期、双交叉空腹状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of captopril tablets in healthy subjects under fasting conditions
1主要研究目的
以中孚药业股份有限公司生产的卡托普利片为受试制剂,以アルフレッサファーマ株式会社生产的卡托普利片(商品名:CAPTORIL®)为参比制剂,按生物等效性试验的相关规定,比较卡托普利片在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
2次要研究目的
评价中国健康受试者单次空腹口服卡托普利片受试制剂和参比制剂后的安全性。
[Translation] 1Main study objectives
Captopril tablets produced by Zhongfu Pharmaceutical Co., Ltd. were used as the test preparation, and Captopril tablets (trade name: CAPTORIL®) produced by Alfred Pharmaceuticals Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of Captopril tablets in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations.
2Secondary study objectives
Evaluate the safety of the test preparation and reference preparation of Captopril tablets after a single oral administration on an empty stomach in healthy Chinese subjects.
/ TerminatedNot Applicable 卡托普利片在健康受试者中随机、开放、单剂量、双周期、双交叉空腹状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of captopril tablets in healthy subjects under fasting conditions
以中孚药业股份有限公司提供的卡托普利片为受试制剂,按生物等效性试验的有关规定,与第一三共エスファ株式会社生产的卡托普利片(商品名:CAPTORIL®,参比制剂)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
[Translation] Captopril tablets provided by Zhongfu Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, the relative bioavailability in healthy humans was compared with that of Captopril tablets produced by Daiichi Sankyo Esfa Co., Ltd. (trade name: CAPTORIL®, reference preparation) to investigate the bioequivalence of the two preparations in humans.
/ Not yet recruitingPhase 3 评价盐酸西替利嗪注射液治疗急性荨麻疹的有效性和安全性随机、双盲、阳性药物平行对照的多中心III 期临床试验
[Translation] A randomized, double-blind, positive drug-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria
以阳性药物为对照,评价盐酸西替利嗪注射液治疗急性荨麻疹的有效性和安全性
[Translation] To evaluate the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria using positive drugs as control
100 Clinical Results associated with Zhongfu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhongfu Pharmaceutical Co., Ltd.
100 Deals associated with Zhongfu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhongfu Pharmaceutical Co., Ltd.