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Clinical Trials associated with MTS-008一项评价MTS008缓释片在健康受试者中单次给药后药代动力学对比及食物影响的I期临床研究
[Translation] A Phase I clinical study to evaluate the pharmacokinetics and food effects of MTS008 extended-release tablets after a single dose in healthy subjects
第一部分:MTS008缓释片四个制剂生物利用度(BA)预试验
主要目的:
与参比制剂依帕司他片(R,商品名:Kinedak®片,小野药品工业株式会社生产,杭州剂泰医药科技有限责任公司提供)比较,考察健康成人受试者单次空腹给予MTS008受试制剂(广州玻思韬控释药业有限公司生产,杭州剂泰医药科技有限责任公司提供)的药代动力学(PK)特征,确定优选受试制剂并为后续开展BA研究提供数据参考。
次要目的:
评估受试制剂在健康成年受试人群中的安全性。
第二部分:MTS008缓释片与参比制剂依帕司他片比较试验和食物对MTS008缓释片影响研究
主要目的:
健康成年受试者空腹或餐后给予受试制剂(根据第一部分研究选取的优选受试制剂,广州玻思韬控释药业有限公司生产,杭州剂泰医药科技有限责任公司提供)和参比制剂依帕司他片(R,商品名:Kinedak®片,小野药品工业株式会社生产,杭州剂泰医药科技有限责任公司提供),评价在空腹状态下口服MTS008的BA及食物对健康受试者单次口服MTS008后PK特征的影响。
次要目的:
评估受试制剂在健康成年受试人群中单次给药后的安全性。
[Translation] Part I: Preliminary bioavailability (BA) study of four formulations of MTS008 sustained-release tablets
Main purpose:
Compared with the reference formulation epalrestat tablets (R, trade name: Kinedak® tablets, produced by Ono Pharmaceutical Co., Ltd., provided by Hangzhou Jitai Pharmaceutical Technology Co., Ltd.), the pharmacokinetic (PK) characteristics of the MTS008 test formulation (produced by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd., provided by Hangzhou Jitai Pharmaceutical Technology Co., Ltd.) administered to healthy adult subjects on an empty stomach were investigated to determine the preferred test formulation and provide data reference for subsequent BA studies.
Secondary purpose:
Evaluate the safety of the test formulation in healthy adult subjects.
Part II: Comparison of MTS008 sustained-release tablets with reference preparation epalrestat tablets and study of the effect of food on MTS008 sustained-release tablets
Main purpose:
The test preparation (preferred test preparation selected according to the first part of the study, produced by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd., provided by Hangzhou Jitai Pharmaceutical Technology Co., Ltd.) and reference preparation epalrestat tablets (R, trade name: Kinedak® tablets, produced by Ono Pharmaceutical Co., Ltd., provided by Hangzhou Jitai Pharmaceutical Technology Co., Ltd.) were administered to healthy adult subjects on an empty stomach or after meals to evaluate the BA of oral MTS008 in the fasting state and the effect of food on the PK characteristics of MTS008 after a single oral administration in healthy subjects.
Secondary purpose:
Evaluate the safety of the test preparation after a single administration in healthy adult subjects.
100 Clinical Results associated with MTS-008
100 Translational Medicine associated with MTS-008
100 Patents (Medical) associated with MTS-008
100 Deals associated with MTS-008