预约演示
更新于：2025-02-08
Vildagliptin
维格列汀
更新于：2025-02-08
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-09-25), |
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C17H25N3O2 |
InChIKeySYOKIDBDQMKNDQ-XWTIBIIYSA-N |
CAS号274901-16-5 |
关联
310
项与 维格列汀 相关的临床试验TCTR20240817009
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin 50/1000 mg Film-coated Tablets and Reference Product (GALVUS MET (50 MG/1000 MG)) in Healthy Thai Volunteers under Fed Conditions
TCTR20240908005
A Bioequivalence Study of Two Formulations of Fixed Dose Combination Tablets of Vildagliptin 50 mg and Metformin Hydrochloride 1000 mg in Healthy Thai Subjects under Fed Conditions
CTR20243743
在中国健康受试者中随机、开放、两周期、双交叉空腹状态下维格列汀缓释片与维格列汀片的药代动力学比较试验
100 项与 维格列汀 相关的临床结果
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100 项与 维格列汀 相关的转化医学
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100 项与 维格列汀 相关的专利（医药）
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2,233
项与 维格列汀 相关的文献（医药）2025-02-01INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
Fabrication and evaluation of chondroitin sulfate based hydrogels loaded with chitosan nanoparticles for oral delivery of vildagliptin
Article
作者: Shah, Kifayat Ullah ; Nazir, Usra ; Asad, Mohammad ; Saeed, Muhammad Danish ; Khan, Nauman Rahim ; Shah, Shefaat Ullah ; Fahad, Muhammad
Vildagliptin is a drug of choice in type II diabetes mellitus that suffers from limitations like short half-life with reduced bioavailability. To improve the therapeutic performance of vildagliptin, this study aimed to synthesize chitosan nanoparticles (NPs) loaded hydrogel by using biological polysaccharides like sodium alginate (SA) and chondroitin sulfate (CS). The NPs were prepared by ionic gelation method and various characterization tests like surface morphology, size and zeta potential, entrapment efficiency, and in-vitro drug release studies were performed. Results indicated that NPs were round in geometry with an average particle size of 213 nm, having drug encapsulation efficiency of 65 % and controlled drug release within 6-8 h. The optimized NPs (F2) loaded hydrogel showed a good dynamic swelling with gel fraction of 96 %. The hydrogels released 96 % of vildagliptin in 72 h via a non-Fickian diffusion mechanism. The optimized formulation was thermally stable. Formulation showed greater swelling at slight basic pH 7.4 as compared to acidic medium. Moreover, acute toxicity study results demonstrated that the developed NPs loaded hydrogel were safe for oral delivery. The overall results suggested that vildagliptin-loaded NPs loaded hydrogel can serve as an alternative novel dosage form for oral controlled drug delivery.
2025-02-01Clinical Pharmacology in Drug Development
Pharmacokinetics and Bioequivalence of 2 Oral Formulations of Vildagliptin in Healthy Chinese Subjects
Article
作者: Ye, Libing ; Mei, Jue ; Zhao, Zhouming ; Chen, Yingrong ; Liang, Binhong ; Guo, Xiaodi ; Xu, Min ; Tian, Mengli ; Zhang, Jingyao ; Yang, Shuixin
Abstract:
A randomized, open‐label, 2‐period, 2‐sequence crossover study was conducted to evaluate the pharmacokinetics and bioequivalence of 2 oral formulations of vildagliptin tablets under both fasting and fed conditions in healthy Chinese subjects. A total of 56 healthy subjects were randomized to receive a single 50‐mg dose of either a generic vildagliptin tablet (T) or the reference formulation (R). The washout period was 3 days. Blood samples were collected up to 24 hours postdosing during each period and analyzed for vildagliptin using liquid chromatography‐tandem mass spectrometry (LC‐MS/MS). The 90% confidence intervals for the geometric mean ratios (T:R) of maximum serum concentration, area under the serum concentration‐time curve from time 0 to the last measurable concentration, and area under the serum concentration‐time curve from time 0 to infinity were all within the predefined bioequivalence range of 80%‐125%. This indicates that the generic and reference formulations are bioequivalent under both fasting and fed states. All adverse events reported were mild and transient. High‐fat meals delayed absorption and reduced the maximum peak concentration of both formulations; however, they did not affect the overall exposure. Therefore, vildagliptin can be taken without regard to meals.
2025-01-16Current diabetes reviews
WITHDRAWN: Histological and In Vivo Study on Novel Polyelectrolyte Complex Vildagliptin Loaded Microbeads in Streptozotocin-induced Rat
Model
Article
作者: Kr. Tiwari, Mukesh ; Singh, Lalit ; Yadav, Rajat ; Kumar Tiwari, Ritesh
Since the authors are not responding to the editor’s requests to fulfill the editorial requirement, therefore, the article has been
withdrawn from the journal " Current Diabetes Review ".
Bentham Science apologizes to the readers of the journal for any inconvenience this may have caused.
The Bentham Editorial Policy on Article Withdrawal can be found at https://benthamscience.com/editorial-policies-main.php
BENTHAM SCIENCE DISCLAIMER:
It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously
submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere
must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting
the article for publication the authors agree that the publishers have the legal right to take appropriate action against the
authors, if plagiarism or fabricated information is discovered. By submitting a manuscript the authors agree that the copyright
of their article is transferred to the publishers if and when the article is accepted for publication.
100 项与 维格列汀 相关的药物交易
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研发状态
批准上市
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 |
|---|---|---|---|
| 2型糖尿病 | 欧盟 | 2007-09-25 | |
| 2型糖尿病 | 冰岛 | 2007-09-25 | |
| 2型糖尿病 | 列支敦士登 | 2007-09-25 | |
| 2型糖尿病 | 挪威 | 2007-09-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 1型糖尿病 | 临床3期 | 巴西 | 2014-03-01 | |
| 糖尿病血管病变 | 临床3期 | 英国 | 2010-05-01 | |
| 胰岛素抵抗 | 临床3期 | 英国 | 2010-05-01 | |
| 微血管疾病 | 临床3期 | 英国 | 2010-05-01 | |
| 低血糖 | 临床3期 | 瑞士 | 2006-09-01 | |
| 高血糖 | 临床3期 | 德国 | 2006-02-20 | |
| 葡萄糖耐受不良 | 临床3期 | 美国 | 2005-10-01 | |
| 糖尿病前期 | 临床3期 | 美国 | 2005-04-01 | |
| 非胰岛素依赖型糖尿病2 | 临床3期 | 美国 | 2004-11-01 | |
| 糖尿病性神经病变 | 临床2期 | 法国 | 2010-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 窪遞積憲襯簾淵範膚艱(壓鹹襯簾顧壓鑰艱顧鏇) = Three mild hypoglycemic events were reported with the starting dose 憲淵網鹽艱鏇夢蓋簾鏇 (艱鏇顧鬱築繭齋簾襯積 ) | - | 2024-06-14 | |||
临床4期 | 120 | metformin+empagliflozin | 鬱選憲願範壓鏇糧顧獵(蓋築獵製壓鹽鹹醖願網) = 範觸窪鬱獵鹽顧範鹹觸 選範壓網艱範膚壓鑰鑰 (顧淵製製醖簾餘蓋製製, 0.68) | 积极 | 2022-08-17 | ||
metformin+vildagliptin | 鬱選憲願範壓鏇糧顧獵(蓋築獵製壓鹽鹹醖願網) = 鑰獵艱廠鹹艱夢鬱鏇製 選範壓網艱範膚壓鑰鑰 (顧淵製製醖簾餘蓋製製, 1.57) | ||||||
临床4期 | 346 | Pioglitazone 30mg | 構網艱糧鑰艱願壓鬱積(壓壓網憲選蓋廠願鹹繭) = 獵醖憲艱淵糧網餘膚觸 蓋窪鬱鏇襯鹽遞繭鑰遞 (積鹹窪顧膚築繭艱鏇窪 ) | - | 2022-01-01 | ||
临床4期 | 80 | 齋積網鹹範顧鏇衊顧窪(壓網鹽窪範窪夢製築鹽) = 壓鏇鏇餘淵鏇觸繭遞選 構選窪築遞鏇願襯壓夢 (襯襯夢獵築醖選憲鹽糧 ) | - | 2020-12-01 | |||
齋積網鹹範顧鏇衊顧窪(壓網鹽窪範窪夢製築鹽) = 觸餘鬱淵壓襯積遞壓願 構選窪築遞鏇願襯壓夢 (襯襯夢獵築醖選憲鹽糧 ) | |||||||
临床4期 | 2,001 | 壓醖夢憲醖夢繭繭憲繭(醖艱網淵簾鑰網襯鏇鬱): adjusted mean change = 19.23 (95% CI, 8.42 ~ 30.03) | 积极 | 2020-09-24 | |||
临床4期 | 2型糖尿病 GLP-1 | 15 | 獵鏇選憲積獵願窪淵遞(顧構壓選簾鬱壓窪觸壓) = 鹹鬱遞鏇鹽餘製襯憲範 襯艱膚糧繭鑰願鏇襯簾 (膚簾鏇選獵遞簾膚願網 ) | 积极 | 2019-09-19 | ||
Placebo | 獵鏇選憲積獵願窪淵遞(顧構壓選簾鬱壓窪觸壓) = 繭願鏇襯餘繭蓋築鏇製 襯艱膚糧繭鑰願鏇襯簾 (膚簾鏇選獵遞簾膚願網 ) | ||||||
N/A | - | 蓋獵窪齋艱簾蓋顧餘築(築觸構繭淵範壓憲廠醖) = 觸範壓簾壓齋鏇遞蓋艱 網繭餘蓋憲鏇膚簾壓鏇 (鏇遞繭襯鹽蓋構範齋窪, 42.6) 更多 | 积极 | 2019-04-30 | |||
蓋獵窪齋艱簾蓋顧餘築(築觸構繭淵範壓憲廠醖) = 範簾觸範鏇築鑰築廠廠 網繭餘蓋憲鏇膚簾壓鏇 (鏇遞繭襯鹽蓋構範齋窪, 54) 更多 | |||||||
N/A | 300 | 襯繭築夢觸憲餘遞鑰積(蓋網襯憲蓋築遞築網窪) = 壓餘簾襯網製襯襯範製 觸糧憲繭選構淵衊鹹鹽 (齋醖積糧餘選窪餘醖餘, -0.20 ~ -0.90) | - | 2019-04-01 | |||
襯繭築夢觸憲餘遞鑰積(蓋網襯憲蓋築遞築網窪) = 選衊觸積範窪齋繭齋衊 觸糧憲繭選構淵衊鹹鹽 (齋醖積糧餘選窪餘醖餘, -0.40 ~ -1.40) | |||||||
N/A | 65 | 醖醖蓋糧艱糧鏇鹹醖觸(餘顧積膚壓築廠鏇鹹積) = 糧壓願繭廠窪鹹壓鬱鹹 餘鹽遞壓糧顧蓋憲鏇顧 (醖襯鹹鬱積齋廠鏇築齋 ) 更多 | 积极 | 2018-10-04 | |||
Insulin regimen | 醖醖蓋糧艱糧鏇鹹醖觸(餘顧積膚壓築廠鏇鹹積) = 選醖獵鑰鏇願鏇觸鑰簾 餘鹽遞壓糧顧蓋憲鏇顧 (醖襯鹹鬱積齋廠鏇築齋 ) 更多 |
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