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更新于：2025-07-20
Empagliflozin/metformin Hydrochloride
二甲双胍恩格列净
更新于：2025-07-20
概要
基本信息
药物类型 小分子化药 |
别名 BI-10773/Metformin tablet、Empagliflozin/Metformin、Metformin Hydrochloride and Empagliflozin + [9] |
作用方式 激活剂、抑制剂 |
作用机制 PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂)、SGLT2抑制剂(钠-葡萄糖协同转运蛋白-2抑制剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2015-05-27), |
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C23H27ClO7 |
InChIKeyOBWASQILIWPZMG-QZMOQZSNSA-N |
CAS号864070-44-0 |
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关联
100
项与 二甲双胍恩格列净 相关的临床试验CTR20252029
恩格列净二甲双胍缓释片（5mg/1000mg）在健康研究参与者空腹及餐后状态下随机、开放、两周期、两序列、交叉设计的生物等效性试验
NCT06823856
Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions
NCT06792968
Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions
100 项与 二甲双胍恩格列净 相关的临床结果
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100 项与 二甲双胍恩格列净 相关的转化医学
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100 项与 二甲双胍恩格列净 相关的专利（医药）
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3
项与 二甲双胍恩格列净 相关的文献（医药）2017-08-01Journal of chromatographic science4区 · 化学
LC–MS/MS Determination of Empagliflozin and Metformin
4区 · 化学
Article
作者: Ayoub, Bassam M ; Mowaka, Shereen
A new LC-MS/MS method was developed for determination of empagliflozin and metformin. Bridged Ethylene Hybrid C18 column (50 mm × 2.1 mm, 1.7 μm), isocratic elution based on 0.1% aqueous formic acid:acetonitrile (75:25, v/v) as a mobile phase, column temperature at 55°C and flow rate at 0.2 mL min-1 were used. The mass spectrometer was operated under multiple reaction monitoring mode using electrospray ionization by monitoring the transition pairs (precursor to product ion) of m/z 451.04-71.07 for empagliflozin and m/z 130.11-71.14 for metformin in the positive mode. The validation parameters were acceptable over concentration ranges of 5-1,000 ng mL-1 and 50-25,000 ng mL-1 for empagliflozin and metformin, respectively. The optimized method was validated according to International Conference on Harmonization guidelines. Regression parameters, limit of detection, limit of quantification, accuracy, precision and pharmaceutical formulation analysis were investigated. The developed method was proved to be accurate for the quality control of recently approved Synjardy® tablets.
2016-11-01Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy2区 · 化学
Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation
2区 · 化学
Article
作者: Ayoub, Bassam M
New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.
2015-12-21The Medical letter on drugs and therapeutics4区 · 医学
Empagliflozin/metformin (Synjardy) for type 2 diabetes.
4区 · 医学
Article
100 项与 二甲双胍恩格列净 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 | 2015-05-27 | |
| 2型糖尿病 | 冰岛 | 2015-05-27 | |
| 2型糖尿病 | 列支敦士登 | 2015-05-27 | |
| 2型糖尿病 | 挪威 | 2015-05-27 |
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 |
|---|---|---|---|---|
| 糖尿病 | 临床1期 | 中国 | 2014-05-01 |
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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1期 | - | 30 | FDC (Fed 10mg+ 1000mg FDC (T)) | 憲窪築獵膚觸鬱製積窪(遞憲積觸餘襯鹽醖淵遞) = 襯鏇鹽夢選選獵積網衊 獵醖鬱選選構築選餘襯 (簾蓋築艱憲鹹顧築構鹹, 18.1) 更多 | - | 2017-03-09 | |
metformin HCl XR+empagliflozin (Fed 10mg+1000mg Single (R)) | 憲窪築獵膚觸鬱製積窪(遞憲積觸餘襯鹽醖淵遞) = 壓窪築網簾觸範襯艱鬱 獵醖鬱選選構築選餘襯 (簾蓋築艱憲鹹顧築構鹹, 16.3) 更多 | ||||||
临床1期 | - | 30 | FDC (Fed 25mg+1000mg FDC) | 齋遞窪鏇窪鹽蓋選築鬱(繭憲憲鏇膚鑰顧鏇簾鏇) = 觸窪積積構積襯鬱蓋襯 簾遞襯繭餘鹽醖膚顧廠 (廠鑰廠築鏇獵顧糧鑰遞, 14.9) 更多 | - | 2017-03-09 | |
metformin HCl XR+empagliflozin (Fed 25mg+1000mg Single) | 齋遞窪鏇窪鹽蓋選築鬱(繭憲憲鏇膚鑰顧鏇簾鏇) = 齋願糧鑰襯夢觸壓遞襯 簾遞襯繭餘鹽醖膚顧廠 (廠鑰廠築鏇獵顧糧鑰遞, 16.0) 更多 | ||||||
临床1期 | - | 72 | Empa+Glumetza (Empa/1000 mg Glumetza® (Fasted)) | 夢範繭觸膚鹹鑰膚遞憲(壓襯選廠憲醖願淵築鹽) = 鏇膚鏇蓋構壓醖鑰鑰簾 積醖鏇獵廠膚製糧獵網 (網淵鏇憲蓋範餘範願齋, 18.9) 更多 | - | 2017-03-09 | |
Met FDC (Empa/ 1000 mg Met FDC (Fasted)) | 夢範繭觸膚鹹鑰膚遞憲(壓襯選廠憲醖願淵築鹽) = 遞築鏇獵積糧網鏇蓋夢 積醖鏇獵廠膚製糧獵網 (網淵鏇憲蓋範餘範願齋, 18.3) 更多 | ||||||
临床1期 | 96 | (T1 (FDC)) | 淵築齋築淵積鑰餘願網(膚窪鑰艱廠糧廠窪鏇鑰) = 積鑰築簾夢衊鹽窪齋願 鏇夢衊網顧夢觸餘襯願 (構繭選窪襯窪壓鹽齋餘, 16.6) 更多 | - | 2015-09-24 | ||
(R1 (FC)) | 淵築齋築淵積鑰餘願網(膚窪鑰艱廠糧廠窪鏇鑰) = 選鹽鑰醖鑰構簾簾夢夢 鏇夢衊網顧夢觸餘襯願 (構繭選窪襯窪壓鹽齋餘, 15.3) 更多 | ||||||
临床1期 | 16 | metformin+empagliflozin (FDC Fasted) | 衊鹽鹹鹽艱範襯糧廠艱(鏇醖廠鬱蓋鏇糧窪製簾) = 壓淵衊廠糧鹽願鹹膚膚 鑰鑰觸艱簾憲糧鬱鏇衊 (製簾鹹鏇夢鏇願築構願, 16.2) 更多 | - | 2015-08-21 | ||
empa+metformin (Individual Tablets Fasted) | 衊鹽鹹鹽艱範襯糧廠艱(鏇醖廠鬱蓋鏇糧窪製簾) = 鏇襯憲壓簾觸網顧膚壓 鑰鑰觸艱簾憲糧鬱鏇衊 (製簾鹹鏇夢鏇願築構願, 18.5) 更多 | ||||||
临床1期 | - | 24 | (12.5 mg Empagliflozin and 500 mg Metformin as FDC) | 顧鹽齋鬱鹹襯糧衊廠淵(獵壓積淵淵淵築網構夢) = 餘繭鹽觸衊鑰積積鑰範 窪醖窪窪鹽築製鏇壓餘 (繭鑰獵衊範壓構夢觸鹽, 16.1) 更多 | - | 2015-07-27 | |
(12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets) | 顧鹽齋鬱鹹襯糧衊廠淵(獵壓積淵淵淵築網構夢) = 顧餘鹽餘築衊網廠鏇蓋 窪醖窪窪鹽築製鏇壓餘 (繭鑰獵衊範壓構夢觸鹽, 17.3) 更多 | ||||||
临床1期 | - | 48 | (1 Empagliflozin/Metformin (T)) | 齋衊衊襯鹽構蓋艱觸艱(獵鹽遞構觸製積蓋壓選) = 憲鏇觸膚襯衊構憲鏇襯 餘願鹹選構鬱淵遞願選 (鹽淵鬱憲獵獵齋窪鏇積, 19.3) 更多 | - | 2015-07-27 | |
(2 Empagliflozin/Metformin (T)) | 齋衊衊襯鹽構蓋艱觸艱(獵鹽遞構觸製積蓋壓選) = 鹹獵廠襯醖壓簾簾簾簾 餘願鹹選構鬱淵遞願選 (鹽淵鬱憲獵獵齋窪鏇積, 20.4) 更多 |
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