甲硝唑片在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验
[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of metronidazole tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较口服受试制剂甲硝唑片(生产厂家:江西新赣江药业股份有限公司)与参比制剂甲硝唑片(持证商:Sanofi,商品名:Flagyl®)在健康受试者体内空腹/餐后状态下的药代动力学行为,评价两种制剂在空腹/餐后条件下是否具有生物等效性。
次要目的:观察受试制剂甲硝唑片和参比制剂甲硝唑片在健康受试者中的安全性。
[Translation] Main purpose: To compare the pharmacokinetic behavior of the oral test preparation metronidazole tablets (manufacturer: Jiangxi Xin Ganjiang Pharmaceutical Co., Ltd.) and the reference preparation metronidazole tablets (certificate holder: Sanofi, trade name: Flagyl®) in healthy subjects under fasting/postprandial conditions, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate whether the two preparations are bioequivalent under fasting/postprandial conditions.
Secondary purpose: To observe the safety of the test preparation metronidazole tablets and the reference preparation metronidazole tablets in healthy subjects.
卡托普利片在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting bioequivalence study of captopril tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹状态下口服受试制剂江西新赣江药业股份有限公司提供的卡托普利片与参比制剂卡托普利片(生产厂家:E. R. Squibb & Sons Limited,商品名:CAPOTENTM)后在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。
次要目的:观察受试制剂卡托普利片和参比制剂卡托普利片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Captopril Tablets provided by Jiangxi Xin Ganjiang Pharmaceutical Co., Ltd. and the reference preparation Captopril Tablets (manufacturer: E. R. Squibb & Sons Limited, trade name: CAPOTENTM) in healthy subjects after oral administration under fasting state was compared to evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation Captopril Tablets and the reference preparation Captopril Tablets in healthy subjects.
单中心、开放、随机、两周期、双交叉设计的琥珀酸多西拉敏片空腹及餐后人体生物等效性试验
[Translation] A single-center, open, randomized, two-period, double-crossover design bioequivalence study of doxylamine succinate tablets in fasting and fed subjects
空腹和餐后给药条件下,以药代动力学参数为终点指标,评价江西新赣江药业股份有限公司仿制的琥珀酸多西拉敏片(规格25mg)与CHATTEM INC生产的琥珀酸多西拉敏片(规格25mg)在18周岁及以上男女健康受试者的生物等效性。
[Translation] The bioequivalence of doxylamine succinate tablets (25 mg) manufactured by Jiangxi Xinganjiang Pharmaceutical Co., Ltd. and doxylamine succinate tablets (25 mg) manufactured by CHATTEM INC was evaluated in healthy male and female subjects aged 18 years and above under fasting and postprandial administration conditions, with pharmacokinetic parameters as endpoints.
100 Clinical Results associated with Jiangxi New Ganjiang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangxi New Ganjiang Pharmaceutical Co., Ltd.
100 Deals associated with Jiangxi New Ganjiang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangxi New Ganjiang Pharmaceutical Co., Ltd.