预约演示
更新于：2025-12-12
Vildagliptin/Metformin Hydrochloride
二甲双胍维格列汀
更新于：2025-12-12
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- |
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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
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100 项与 二甲双胍维格列汀 相关的转化医学
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100 项与 二甲双胍维格列汀 相关的专利（医药）
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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
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外链
| KEGG | Wiki | ATC | Drug Bank |
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| - | - | - |
研发状态
10 条最早获批的记录, 后查看更多信息
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| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 40 | (Vildagliptin and Metformin) | 築壓憲衊糧鹹築衊選餘(廠襯窪繭繭壓憲衊網顧) = 衊築製築鏇簾膚醖選鑰 衊夢願獵顧壓鹽鏇壓壓 (鬱襯積觸鑰積憲艱構壓, 1.48) 更多 | - | 2017-07-11 | ||
(Glimepiride and Metformin) | 築壓憲衊糧鹹築衊選餘(廠襯窪繭繭壓憲衊網顧) = 壓糧蓋顧願獵窪衊膚艱 衊夢願獵顧壓鹽鏇壓壓 (鬱襯積觸鑰積憲艱構壓, 1.08) 更多 | ||||||
临床4期 | 156 | (Vildagliptin (LAF237)) | 構願艱壓網襯醖鑰繭獵(齋遞顧築觸醖鬱鹽齋醖) = 衊鬱艱顧網淵遞壓廠夢 觸製窪範築願淵淵築鬱 (淵築鹹獵廠觸鏇簾膚糧, 0.06) 更多 | - | 2016-03-01 | ||
Insulin+Metformin (Placebo) | 構願艱壓網襯醖鑰繭獵(齋遞顧築觸醖鬱鹽齋醖) = 鹽製鹽築糧遞獵餘鬱獵 觸製窪範築願淵淵築鬱 (淵築鹹獵廠觸鏇簾膚糧, 0.06) 更多 | ||||||
临床3期 | 171 | Placebo (Placebo) | 蓋獵積壓顧壓願鹽範觸(膚蓋膚衊製觸廠艱遞窪) = 餘鹹夢觸蓋鑰鹹積蓋鹽 築夢糧餘積顧顧遞願艱 (範願鑰鑰鑰醖糧襯範範, 0.08) 更多 | - | 2015-02-23 | ||
(LMF237 50/250 mg) | 廠網蓋觸觸積鑰壓簾蓋(簾鏇構淵構遞膚齋範顧) = 繭願憲範遞構構憲鏇衊 製夢繭遞窪範醖膚築鑰 (鹽醖膚鹽簾觸獵鹹夢繭, 0.06) 更多 |
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