预约演示
更新于：2026-03-17
Saxagliptin Hydrochloride/Metformin Hydrochloride
盐酸沙格列汀/盐酸二甲双胍
更新于：2026-03-17
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2010-11-05), |
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C22H38Cl2N8O2 |
InChIKeyGTSUONGZHGBCPP-ZEGDOHPJSA-N |
CAS号1431862-06-4 |
关联
27
项与 盐酸沙格列汀/盐酸二甲双胍 相关的临床试验CTR20252379
评估受试制剂沙格列汀二甲双胍缓释片（I）与参比制剂安立格®（Kombiglyze® XR）在健康成年受试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、双交叉生物等效性试验
CTR20251495
沙格列汀二甲双胍缓释片（Ⅰ）（5mg/1000mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验。
CTR20241754
沙格列汀二甲双胍缓释片（I）在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究
100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的临床结果
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100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的转化医学
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100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的专利（医药）
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9
项与 盐酸沙格列汀/盐酸二甲双胍 相关的文献（医药）2021-05-01MICROCHEMICAL JOURNAL
Green methods for the simultaneous analysis of pharmaceutical mixtures present in disparate concentration ranges: Application to antidiabetic mixtures
作者: Amira F. El-Yazbi
Diabetes-mellitus is one of the most common chronic diseases worldwide.Today, many single-pill combinations exist and are indicated especially for diabetic patients who are unable to achieve sufficient glycemic-control with one active component.However, some of these combinations are formulated in concentration ratios that present a real challenge for their anal. and quality-control assessment.For instant, linagliptin (L) and saxagliptin (S) are two oral dipeptidylpeptidase-4 inhibitors that have recently been formulated with metformin (M) in a ratio of 1:400 with almost no simple anal. methods offered in literature for their anal. in such disparate concentration-ratio.In this study, a simple, fast and green capillary electrophoretic (CE) method was established for the simultaneous determination of L and S with M in pharmaceutical-dosage-forms.The developed method was linear in the range of 2-200μg.mL-1 for L and S and 10-2000μg.mL-1 for M with r > 0.9993 with low LOD and LOQ values that allowed the proposed method to be successfully applied for the sensitive determination of S, L and M in their binary-combinations of S-M and L-M in pharmaceutical-dosage-forms despite the large differences in M and L or S doses.Upon comparison with the few reported-methods, the proposed-method offers the advantages of high separation efficiency and low solvent consumption.In addition to using simple aqueous-buffer that adds to the greenness of the method and decrease the cost of operation.The Eco-scale penalty points approach and the Green Anal. Procedure Index were applied to assess the greenness of the developed method.Results revealed that the proposed method is a greener alternative to the reported ones This allows our proposed-method to be used for the routine high-through-put anal. required in quality-control laboratories as an efficient and simple eco- friendly anal.-tool.
2019-04-03JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets
作者: Maher, Hadir M. ; Abdelrahman, Afnan E. ; Alzoman, Nourah Z. ; Aljohar, Haya I.
A capillary electrophoretic method coupled to a diode array detector (CE-DAD) was developed and validated for the simultaneous determination of metformin hydrochloride (MET), the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin hydrochloride (SAX), and the sodium glucose co-transporter (SGLT 2) inhibitor dapagliflozin (DAP).The proposed method was used for the determination of these drugs in binary antidiabetic combinations namely, SAX/MET, combination I, DAP/MET, combination II, and SAX/DAP, combination III.CE separation was performed on a fused silica capillary with background electrolyte consisting of 30 mM phosphate buffer (pH 6.0) with a high voltage of 30 kV, a pressure of 20 mbar, and an injection time of 40 s.The compounds were detected at 203 nm for SAX/DAP and 250 nm for MET.The method was linear in the concentration range of 10-200 μ g/mL (SAX), 1.25-50 μ g/mL (DAP), and 7.5-1000 μ g/mL (MET).Full validation of the proposed method was performed as per the ICH guidelines.The obtained errors and deviation values did not exceed 2% assessing good accuracy and precision, resp.The stability-indicating potential of the proposed method was proved under different stress-degradation conditions.The proposed method was successfully applied to the anal. of the three binary combinations in their tablets.
2018-10-01JGH open : an open access journal of gastroenterology and hepatology
Kombiglyze (metformin and saxagliptin)‐induced hepatotoxicity in a patient with non‐alcoholic fatty liver disease
作者: Mun, Kein Seong ; Thalha, Abdul Malik ; Boon Tan, Alexander Tong ; Mahadeva, Sanjiv
A 33‐year‐old man was referred with hyperosmotic symptoms of 4 weeks. Clinical examination showed palpable hepatomegaly and no stigmata of liver disease. Findings were random glucose 16.6 mmol/L, HbA1c 12.4%, triglyceride 6.2 mmol/L, normal LFTs and ultrasound liver: increased echogenicity. Management consisted of dietician referral and commencement of metformin 500 mg bd, diamicron MR 60 mg od, and fenofibrate 145 mg od. He was non‐compliant, complaining of “heaviness of head” after consuming oral diabetic agents, without symptoms of hypoglycemia. Treatment was switched to Kombiglyze XR (saxaglipitin 5 mg + metformin 1000 mg) and empagliflozin 25 mg od. He presented 1 week later with generalised pruritus with ALT 307 IU/L and serum GGT 808 IU/L. Following this, a percutaneous liver biopsy was performed, revealing steatohepatitis and marked intra‐hepatic cholestasis. Kombiglyze XR was withheld, with resolution of LFTs to baseline. Phenotypes of liver injury are categorised according to R value, defined as ratio ALT/ULN:ALP/ULN. R value of ≥5:hepatocellular injury, ≤2:cholestatic injury, 2–5:mixed‐type injury. Here, R value points toward mixed type (R = 3.203). Hepatotoxicity in patients with NASH is difficult to diagnose, based on laboratory parameters. Liver histology was useful in indicating additional changes apart from NASH, causing liver derangement. The Rousal Uclaf Causality Assessment Method is a scoring method to determine the probability of drug induced liver injury. RUCAM score for this case was 6 (probable adverse drug reaction). Hepatotoxicity from saxagliptin not been reported prior. Clinicians need to be more vigilant, particularly in patients with NASH.
100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的药物交易
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外链
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖尿病 | 澳大利亚 | 2013-10-10 | |
| 2型糖尿病 | 美国 | 2010-11-05 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 葡萄糖耐受不良 | 临床3期 | 美国 | 2014-03-01 | |
| 多囊卵巢综合征 | 临床3期 | 美国 | 2014-03-01 |
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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3期 | 38 | (Metformin XR) | 齋鹽餘選壓積鬱糧齋膚 = 顧鹹繭糧齋範齋鹹鏇鹹 艱壓選蓋艱鑰積壓繭顧 (襯製繭觸壓製鏇襯餘齋, 糧醖網廠遞夢積網觸鬱 ~ 憲構齋遞鹽遞簾壓夢鏇) 更多 | - | 2017-06-28 | ||
(Saxagliptin) | 齋鹽餘選壓積鬱糧齋膚 = 窪網簾廠窪範壓製選廠 艱壓選蓋艱鑰積壓繭顧 (襯製繭觸壓製鏇襯餘齋, 淵糧壓襯願繭製繭築簾 ~ 鹹廠蓋齋夢願鹹繭簾膚) 更多 | ||||||
临床1期 | 24 | (Treatment A) | 壓鑰蓋齋齋齋範網膚選(繭淵糧構鹹糧顧簾糧範) = 膚糧繭願鹹遞醖鑰鹹獵 餘遞夢構膚醖壓獵齋觸 (願蓋築淵觸獵鹹網繭築, 18.52) 更多 | - | 2012-02-08 | ||
(Treatment B) | 壓鑰蓋齋齋齋範網膚選(繭淵糧構鹹糧顧簾糧範) = 膚糧鑰鹽鬱窪醖憲窪積 餘遞夢構膚醖壓獵齋觸 (願蓋築淵觸獵鹹網繭築, 19.72) 更多 | ||||||
临床3期 | 166 | Metformin+Saxagliptin (Saxagliptin 2.5 mg + Metformin Immediate Release (IR)) | 積廠簾鬱鏇鏇願夢廠構(醖鹹製窪選顧齋糧廠範) = 鹹鹽憲顧積獵膚餘膚艱 遞範夢壓觸鏇憲壓鏇願 (齋鏇襯簾夢獵糧製壓齋, 0.11) 更多 | - | 2011-12-16 | ||
Placebo+Metformin (Placebo + Metformin IR) | 積廠簾鬱鏇鏇願夢廠構(醖鹹製窪選顧齋糧廠範) = 遞餘製網獵繭網廠鏇網 遞範夢壓觸鏇憲壓鏇願 (齋鏇襯簾夢獵糧製壓齋, 0.09) 更多 | ||||||
临床1期 | 30 | (Treatment A) | 衊鹹夢遞齋網憲憲鏇廠(衊窪觸選獵鑰鏇齋選襯) = 積獵齋觸蓋繭構廠觸淵 構襯簾簾醖製獵醖觸築 (遞淵範膚觸餘獵選醖膚, 18.34) 更多 | - | 2011-05-17 | ||
(Treatment B) | 衊鹹夢遞齋網憲憲鏇廠(衊窪觸選獵鑰鏇齋選襯) = 簾獵願膚鹹製醖鹹獵壓 構襯簾簾醖製獵醖觸築 (遞淵範膚觸餘獵選醖膚, 23.14) 更多 | ||||||
临床1期 | 24 | (Coadministration of Saxagliptin and Metformin IR (Fasted)) | 網夢獵鹹蓋壓構顧鬱夢(蓋壓網鹽網觸淵獵範蓋) = 壓襯製觸築齋選製衊簾 齋鹽鹹夢蓋鏇憲鬱築廠 (餘鬱構鏇願簾鬱膚鹽築, 2.572) 更多 | - | 2011-03-25 | ||
(Saxagliptin/Metformin FDC (Fasted)) | 網夢獵鹹蓋壓構顧鬱夢(蓋壓網鹽網觸淵獵範蓋) = 製範淵觸簾範遞觸觸構 齋鹽鹹夢蓋鏇憲鬱築廠 (餘鬱構鏇願簾鬱膚鹽築, 2.266) 更多 |
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