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-dose, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial 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 oral test preparation metronidazole tablets (manufacturer: Jiangxi Xinganjiang Pharmaceutical Co., Ltd.) with the reference preparation metronidazole tablets (licensed : Sanofi, trade name: Flagyl®) pharmacokinetic behavior in healthy subjects under fasting/feeding conditions to evaluate whether two formulations are bioequivalent under fasting/feeding conditions.
Secondary objective: To observe the safety of test preparation metronidazole tablets and 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-agent, single-dose, two-cycle, double-crossover fasting bioequivalence trial 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, to compare the captopril tablets provided by the test preparation Jiangxi New Ganjiang Pharmaceutical Co., Ltd. and the reference preparation captopril tablets in fasting state respectively. (Manufacturer: E. R. Squibb & Sons Limited, trade name: CAPOTENTM) after pharmacokinetic behavior in healthy subjects, evaluating the bioequivalence of the two formulations.
Secondary objective: To observe the safety of test preparation captopril tablets and 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-label, randomized, two-cycle, double-crossover design of doxylamine succinate tablets in fasting and postprandial human bioequivalence trial
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] Under the conditions of fasting and postprandial administration, pharmacokinetic parameters were used as end points to evaluate the doxylamine succinate tablets (25mg) produced by Jiangxi Xinganjiang Pharmaceutical Co., Ltd. Bioequivalence of Sylamine Tablets (25mg) in healthy male and female subjects aged 18 years and above.
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.