预约演示
更新于：2026-01-30
Vildagliptin/Metformin Hydrochloride
二甲双胍维格列汀
更新于：2026-01-30
概要
基本信息
药物类型 小分子化药 |
别名 Eucreas、Galvumet、Galvus Met + [21] |
作用方式 抑制剂、激活剂 |
作用机制 DPP-4抑制剂(二肽基肽酶IV抑制剂)、PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂) |
治疗领域 |
非在研适应症- |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C21H37ClN8O2 |
InChIKeyPQETUJCOOSLMAX-OGDHSBAZSA-N |
CAS号2446159-61-9 |
关联
43
项与 二甲双胍维格列汀 相关的临床试验CTR20250997
评估受试制剂二甲双胍维格列汀片（Ⅱ）（规格：850 mg/50 mg）与参比制剂（宜合瑞®/Eucreas®）（规格：850 mg/50 mg）在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验
NCT06248801
A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.
TCTR20230822002
A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vildagliptin and Metformin tablets 50/500 mg relative to GALVUS MET (50MG/500 MG) tablets in healthy Thai adult volunteers under fed condition.
100 项与 二甲双胍维格列汀 相关的临床结果
登录后查看更多信息
100 项与 二甲双胍维格列汀 相关的转化医学
登录后查看更多信息
100 项与 二甲双胍维格列汀 相关的专利（医药）
登录后查看更多信息
10
项与 二甲双胍维格列汀 相关的文献（医药）2022-06-01Diabetes therapy : research, treatment and education of diabetes and related disorders
Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers
Article
作者: Klingberg, Ulrike ; Gaikwad, Sumedh ; Prathap, Vamshi Ramana ; Schnaars, Yvonne ; Vadla, Hari Kiran Chary ; Gottwald-Hostalek, Ulrike
INTRODUCTION:
Vildagliptin and metformin are two well-established oral antidiabetics with a complementary mechanism of action. Two new generic products, vildagliptin and its fixed-drug combination (FDC) with metformin, were tested for bioequivalence versus the approved originator reference products (Galvus® and Eucreas®).
METHODS:
Three randomized studies with two-treatment, two-period, two-sequence crossover design were conducted in healthy adults. One study evaluated vildagliptin 50 mg tablets as single dose under fasting conditions. Vildagliptin-metformin FDC tablet strengths of 50/850 mg and 50/1000 mg were evaluated in separate studies as single dose under fed conditions, given 30 min after a standardized high-fat, high-calorie breakfast following 10 h overnight fasting. Blood samples for analysis were collected until 24 h after dosing in each study period. Bioequivalence between test (T) and reference (R) products required 90% confidence interval (CIs) for the geometric least square (LS) mean T/R ratio to be within 80-125% for the pharmacokinetic parameters, maximum plasma concentration (Cmax), and area under the curve (AUC0-t).
RESULTS:
The 90% CIs of geometric LS means of T/R ratio for Cmax and AUC0-t with vildagliptin tablets of 50 mg were 92.22-103.94% and 99.00-102.66%, respectively; corresponding results with FDC tablets for 50/850 mg tablets were 94.81-115.41% and 95.28-106.00% for vildagliptin and 90.87-101.18% and 90.56-100.09% for metformin; for 50/1000 mg tablets Cmax and AUC0-t were 105.56-122.30% and 98.30-107.55%, respectively, for vildagliptin and 92.14-103.73% and 94.60-101.81%, respectively, for metformin. Other parameters such as AUC0-∞, time to maximum concentration (Tmax), and terminal half-life (t1/2) were comparable between test and reference products. Adverse events (AEs), mainly vomiting, were reported without relevant difference between test and reference products in each study. AEs were generally mild and transient. No severe or serious AEs occurred.
CONCLUSIONS:
The new generic drug products of vildagliptin and the FDCs of vildagliptin and metformin demonstrated bioequivalence to the approved originator products and are therefore expected to provide similar therapeutic effects.
2020-12-01Clinical nutrition ESPEN
Selenium cleome droserifolia nanoparticles (Se-CNPs) and it's ameliorative effects in experimentally induced diabetes mellitus
Article
作者: Elharrif, Mohamed G ; Omnia, M A ; Abou Zaid, Omayma A R ; Alaa, E A ; Abdel Maksoud, H A
Diabetes mellitus is a group of metabolic disorders with great challenge in its treatment due to its pathological complication. In recent decade, there is extensive use of applying nanotechnology to medicinal plants as a trend in diabetes treatment due to phytochemical constituents. The present study aimed to evaluate the hypoglycemic effect of selenium cleome droserifolia nanoparticles (Se-CNPs) and/or Galvus met® treatment on streptozotocin induced diabetes mellitus in male rats. Fifty male Wistar rats were divided equally into five groups: control group, control diabetic group, diabetic group treated with Se-CNPs, diabetic group treated with Galvus met® and diabetic group treated with Se-CNPs plus Galvus met®. Glucose and insulin levels, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST), Total Cholesterol (TC), Triacylglycerols (TG), High Density Lipoprotein (HDL-c), Very Low Density Lipoprotein cholesterol (VLDL-c), Low Density Lipoprotein cholesterol (LDL-c) and (NEFAs), urea and creatinine were evaluated. Also, histopathological changes in pancreatic tissue were examined. The results showed significant elevation in serum glucose concentration, ALT and AST activities, TG, LDL-c, VLDL-c and Non Esterified Fatty Acids (NEFAs), urea and creatinine levels while a significant decrease in serum insulin and HDL-c concentration in untreated diabetic rats when compared with control. Meanwhile, daily administration of Se-CNPs and/or Galvus met® to diabetic rats showed significant amelioration of these parameters.
2011-07-01Regulatory toxicology and pharmacology : RTP4区 · 医学
Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995–2009)
4区 · 医学
Article
作者: Olejniczak, Klaus ; Friedrich, Anita
Carcinogenicity data of medicinal products for human use that have been authorised via the European centralised procedure (CP) between 1995 and 2009 were evaluated. Carcinogenicity data, either from long-term rodent carcinogenicity studies, transgenic mouse studies or repeat-dose toxicity studies were available for 144 active substances contained in 159 medicinal products. Out of these compounds, 94 (65%) were positive in at least one long-term carcinogenicity study or in repeat-dose toxicity studies. Fifty compounds (35%) showed no evidence of a carcinogenic potential. Out of the 94 compounds with positive findings in either carcinogenicity or repeat-dose toxicity studies, 33 were positive in both mice and rats, 40 were positive in rats only, and 21 were positive exclusively in mice. Long-term carcinogenicity studies in two rodent species were available for 116 compounds. Data from one long-term carcinogenicity study in rats and a transgenic mouse model were available for eight compounds. For 13 compounds, carcinogenicity data were generated in only one rodent species. One compound was exclusively tested in a transgenic mouse model. Six compounds were tumourigenic in repeat-dose toxicity studies in rats. The majority of tumour findings observed in rodent carcinogenicity studies were considered not to be relevant for humans, either due to a rodent-specific mechanism of carcinogenicity, a high safety margin between exposures at the NOAEL (No Observed Adverse Effect Level) in rodents and recommended therapeutic doses in humans, or based on historical control data, a small effect size and lack of dose-response relationship and tumours typically observed in rodent strains used, or were considered not to be relevant for humans based on literature and clinical data or likely differences in metabolism/local concentrations between rodents and humans. Due to the high number of rodent tumour findings with unlikely relevance for humans, the value of the currently used testing strategy for carcinogenicity appears questionable. A revision of the carcinogenicity testing paradigm is warranted.
100 项与 二甲双胍维格列汀 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖尿病 | 澳大利亚 | 2010-12-13 | |
| 2型糖尿病 | 欧盟 | 2007-11-14 | |
| 2型糖尿病 | 冰岛 | 2007-11-14 | |
| 2型糖尿病 | 列支敦士登 | 2007-11-14 | |
| 2型糖尿病 | 挪威 | 2007-11-14 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 40 | (Vildagliptin and Metformin) | 遞餘窪構糧齋築願簾襯(構構蓋範鹹齋壓鏇艱獵) = 網憲顧衊齋艱願廠鹽窪 憲築衊範網鏇獵膚淵網 (壓鏇襯簾糧鏇鏇憲齋選, 1.48) 更多 | - | 2017-07-11 | ||
(Glimepiride and Metformin) | 遞餘窪構糧齋築願簾襯(構構蓋範鹹齋壓鏇艱獵) = 網糧築顧獵觸顧鏇憲廠 憲築衊範網鏇獵膚淵網 (壓鏇襯簾糧鏇鏇憲齋選, 1.08) 更多 | ||||||
临床4期 | 156 | (Vildagliptin (LAF237)) | 鹽鏇襯繭壓積鹽製鑰壓(獵鑰鏇夢襯襯範製廠願) = 鏇鹹窪積齋淵獵壓壓築 構醖鹹廠鏇鑰製餘範願 (襯廠膚鹽構餘衊網觸鬱, 0.06) 更多 | - | 2016-03-01 | ||
Insulin+Metformin (Placebo) | 鹽鏇襯繭壓積鹽製鑰壓(獵鑰鏇夢襯襯範製廠願) = 夢鏇醖繭觸淵積餘構網 構醖鹹廠鏇鑰製餘範願 (襯廠膚鹽構餘衊網觸鬱, 0.06) 更多 | ||||||
临床3期 | 171 | Placebo (Placebo) | 構廠遞淵壓選艱艱廠鹽(鑰衊範積齋觸糧範醖鬱) = 鑰網鏇窪鹽遞遞淵淵鏇 願壓製鹹觸壓憲選齋製 (襯鹹簾憲壓構醖鹽鹽網, 0.08) 更多 | - | 2015-02-23 | ||
(LMF237 50/250 mg) | 蓋網蓋構餘窪窪淵構選(衊願選築構遞簾選築齋) = 襯窪窪簾壓壓網選醖淵 糧鑰壓齋鹽獵蓋壓顧獵 (艱網廠簾構襯壓夢壓遞, 0.06) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用