健康志愿者空腹/餐后单次口服尼美舒利分散片的随机、开放、两制剂、两周期、双交叉的人体生物等效性试验
[Translation] A randomized, open-label, two-drug, two-cycle, double-crossover human bioequivalence trial of a single oral nimesulide dispersible tablet in healthy volunteers
主要研究目的
健康受试者空腹或餐后状态下,单次口服湖北舒邦药业有限公司生产的受试制剂尼美舒利分散片或Helsinn Birex Pharmaceutical Ltd.生产的参比制剂尼美舒利片,分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的
考察尼美舒利受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose
Healthy subjects took a single oral dose of the test preparation nimesulide dispersible tablets produced by Hubei Shubang Pharmaceutical Co., Ltd. or the reference preparation nimesulide tablets produced by Helsinn Birex Pharmaceutical Ltd. on an empty stomach or after meals, respectively. The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects in fasting and postprandial states were investigated, and the bioequivalence of the two preparations was evaluated.
Secondary research purpose
To investigate the safety of nimesulide test preparation and reference preparation in healthy subjects.
拉呋替丁片单中心、随机、开放、双周期、双交叉设计在中国健康受试者空腹和餐后的生物等效性试验
[Translation] A single-center, randomized, open-label, two-cycle, two-crossover design of lafutidine tablet bioequivalence trial in healthy Chinese subjects with fasting and postprandial
主要目的:评价湖北舒邦药业有限公司的拉呋替丁片(规格:5mg/片)与大鹏药业工业株式会社的拉呋替丁片(规格: 5mg/片)在健康成年受试者空腹和餐后状态下单次口服给药的人体生物等效性。
次要目的:评价拉呋替丁片在健康成年受试者中的安全性。
[Translation] Main purpose: To evaluate the lafutidine tablets (specification: 5mg/tablet) of Hubei Shubang Pharmaceutical Co., Ltd. and Lafutidine Tablets (specification: 5mg/tablet) of Dapeng Pharmaceutical Industry Co., Ltd. in healthy adults. Human bioequivalence of a single oral dose in the fasted and fed states.
Secondary objective: To evaluate the safety of lafutidine tablets in healthy adult subjects.
非那雄胺片在健康受试者中餐后用药,两制剂、两周期、两序列、随机、开放、自身交叉的平均生物等效性研究
[Translation] Mean bioequivalence study of two preparations, two cycles, two sequences, randomized, open-label, self-crossover of finasteride tablets in healthy subjects after meals
主要研究目的:本研究以湖北舒邦药业有限公司生产的非那雄胺片(5mg)为受试制剂,Merck Sharp & Dohme limited的非那雄胺片(5mg)(商品名:保列治®)为参比制剂,评价二者是否为生物等效制剂,为临床安全、合理用药提供理论依据。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research purposes: In this study, finasteride tablets (5mg) produced by Hubei Shubang Pharmaceutical Co., Ltd. were used as the test preparation, and finasteride tablets (5mg) from Merck Sharp & Dohme limited (trade name: Proscar ®) as the reference preparation, evaluate whether the two are bioequivalent preparations, and provide a theoretical basis for clinical safety and rational drug use.
Secondary research objectives: To observe the safety of the test preparation and reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Hubei Shubang Pharmaceutical Co., Ltd.
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