主要目的：以法国赛诺菲-万安特公司生产Amaryl®M为参比制剂，对比华中药业生产的格列美脲二甲双胍片（受试制剂），考察健康志愿者单次口服格列美脲二甲双胍片在人体的血药浓度及主要药代动力学参数，并评价其生物等效性。次要目的：观察格列美脲二甲双胍片（受试制剂）和格列美脲二甲双胍片（参比制剂）在健康受试者中的安全性。

开始日期2019-04-25

申办/合作机构

华中药业股份有限公司

NCT02395237 / Withdrawn临床1期IIT

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

开始日期2015-05-01

申办/合作机构

Pharmaceutical Research Unit, Jordan

[+1]

NCT01890629 / Completed临床4期

A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

开始日期2013-05-01

申办/合作机构

LG Life Sciences Ltd.

100 项与格列美脲/盐酸二甲双胍相关的临床结果

登录后查看更多信息

100 项与格列美脲/盐酸二甲双胍相关的转化医学

登录后查看更多信息

100 项与格列美脲/盐酸二甲双胍相关的专利（医药）

登录后查看更多信息

项与格列美脲/盐酸二甲双胍相关的文献（医药）

2014-11-01·Pakistan journal of pharmaceutical sciences

A simple and convenient method for the simultaneous in vitro study of metformin and glimepiride tablets.

Article

作者: Ahmed, Rehan

A simple and convenient method was developed for the simultaneous determination of metformin HCl and glimepiride in tablet dosage form of different pharmaceuticals companies. This method was validated and proved to be applicable for assay determination in intermediate and finished staged. More over a single medium dissolution of metformin HCl and glimepiride was established and the media was evaluated for comparative studies for different formulations. Reverse phase HPLC equipped with UV detector was used for the determination of metformin HCl and glimepiride. A mixture of acetonitrile and ammonium acetate buffer 0.05M pH 3.0 was used as mobile phase at flow rate of 1.0ml/min. Promocil C18 5µ 100Aº 4.6 x 100mm C18 silica column was used and detection was carried out at 270nm. Method was found to be linear over the range of 4ppm to 16ppm for glimepiride and 170ppm to 680ppm for metformin HCl. Regression co-efficient were found to be 0.9949 and 0.9864 for glimepiride and metformin HCl respectively. Dissolution was performed in 500ml 0.2% sodium lauryl sulfate at 37°C for 45min using paddle apparatus. Dissolution of glimepiride was found to be 98.60% and 101.08% in Orinase Met1 tablet and Amaryl M tablet respectively whereas metformin was found 99.41% and 98.59% in Orinase Met 1 tablet and Amaryl M tablet. RSD for all the dissolutions was less than 2.0% after completion.

100 项与格列美脲/盐酸二甲双胍相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
2型糖尿病	-	Sanofi	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01561976 (CTgov)	N/A	2型糖尿病	30	METLEAD ForteSR (METLEAD ForteSR-Fasting)	鹹築選遞構選廠鏇醖鑰(築齋願襯範淵鹹鹽簾糧) = 遞鏇鏇廠範糧膚繭憲構鏇觸窪網鑰鑰襯積築觸 (醖遞顧艱壓遞襯獵鑰蓋, 糧鬱築網蓋衊窪遞蓋齋 ~ 廠觸壓製鏇鬱範鹽艱壓) 更多	-	2017-10-16
				ForteSR (METLEAD ForteSR-Fed)	鹹築選遞構選廠鏇醖鑰(築齋願襯範淵鹹鹽簾糧) = 窪鹽蓋構願願餘鏇廠壓鏇觸窪網鑰鑰襯積築觸 (醖遞顧艱壓遞襯獵鑰蓋, 齋醖糧構襯顧壓製糧網 ~ 構製選鹹醖鏇築憲築網) 更多
NCT00612144 (Pubmed \| J Diabetes Investig)	临床4期	2型糖尿病	209	Glimepiride/Metformin fixed-dose combination	(構艱衊築廠鏇憲壓糧衊) = 鏇繭簾簾齋廠觸膚夢鏇艱鑰構襯膚鏇衊簾餘蓋 (構獵選鹽選糧憲鑰簾鹹 ) 更多	-	2014-11-01
				Metformin uptitration	(構艱衊築廠鏇憲壓糧衊) = 鹽衊遞獵繭顧廠簾窪鏇艱鑰構襯膚鏇衊簾餘蓋 (構獵選鹽選糧憲鑰簾鹹 ) 更多