[Translation] Study on the bioequivalence of sodium chloride butylphthalide injection in healthy volunteers
主要目的:本试验旨在研究健康受试者单次空腹静脉滴注江西科伦药业有限公司研制、生产的丁苯酞氯化钠注射液(100 ml:丁苯酞25 mg与氯化钠0.9 g)的药代动力学特征;以石药集团恩必普药业有限公司生产的丁苯酞氯化钠注射液(恩必普®,100 ml:丁苯酞25 mg与氯化钠0.9 g)为参比制剂,比较两制剂中的药动学参数,评价两制剂的人体生物等效性。
次要目的:评估受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This study aims to study the pharmacokinetic characteristics of a single fasting intravenous drip of sodium butylphthalide injection (100 ml: 25 mg butylphthalide and 0.9 g sodium chloride) developed and produced by Jiangxi Kelun Pharmaceutical Co., Ltd. in healthy subjects; using sodium butylphthalide injection (ENBIP®, 100 ml: 25 mg butylphthalide and 0.9 g sodium chloride) produced by CSPC Pharmaceutical Group Enbi Pharmaceutical Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters of the two preparations and evaluate the human bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.
盐酸毛果芸香碱滴眼液在老视患者中随机、双盲、单次和多次给药的药代动力学研究
[Translation] A randomized, double-blind, single-dose and multiple-dose pharmacokinetic study of pilocarpine hydrochloride eye drops in presbyopic patients
主要研究目的:评价盐酸毛果芸香碱滴眼液受试制剂与参比制剂盐酸毛果芸香碱滴眼液(Vuity)的药代动力学特征。
次要研究目的:考察受试制剂和参比制剂在受试者给药后的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test preparation of pilocarpine hydrochloride eye drops and the reference preparation of pilocarpine hydrochloride eye drops (Vuity).
The secondary purpose of the study is to investigate the safety of the test preparation and the reference preparation after administration to the subjects.
[Translation] Study on the bioequivalence of iguratimod tablets in healthy volunteers
主要目的:本试验旨在研究单次空腹和餐后口服江西科伦药业有限公司生产的艾拉莫德片(25 mg)的药代动力学特征;以海南先声药业有限公司生产的艾拉莫德片(艾得辛®,25 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of aguratimod tablets (25 mg) produced by Jiangxi Kelun Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using aguratimod tablets (Edixin®, 25 mg) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations, and evaluate the bioequivalence of the two preparations in humans.
Secondary objective: Observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Jiangxi Kelun Medicine Industry Co. Ltd.
0 Patents (Medical) associated with Jiangxi Kelun Medicine Industry Co. Ltd.
100 Deals associated with Jiangxi Kelun Medicine Industry Co. Ltd.
100 Translational Medicine associated with Jiangxi Kelun Medicine Industry Co. Ltd.