A Phase I, Randomized, Open-Label, Single-Dose, Crossover Study to Evaluate Food Effect on the Pharmacokinetics and Safety of CT-L01 After Oral Administration in Healthy Volunteers

This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.

开始日期2022-07-09

申办/合作机构

Celltrion, Inc.

NCT05363592 / Completed临床1期

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.

开始日期2022-06-25

申办/合作机构

Celltrion, Inc.

NCT05363384 / Completed临床1期

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 25 mg and MET XR 1,000 mg or Administration of CT-L01 25/1,000 mg in Healthy Volunteers

开始日期2022-06-11

申办/合作机构

Celltrion, Inc.

100 项与苯甲酸阿格列汀/盐酸二甲双胍相关的临床结果

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100 项与苯甲酸阿格列汀/盐酸二甲双胍相关的转化医学

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100 项与苯甲酸阿格列汀/盐酸二甲双胍相关的专利（医药）

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项与苯甲酸阿格列汀/盐酸二甲双胍相关的文献（医药）

2017-11-01·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy2区 · 化学

Comparative study between different simple methods manipulating ratio spectra for the analysis of alogliptin and metformin co-formulated with highly different concentrations

2区 · 化学

Article

作者: Zaghary, Wafaa A ; Mowaka, Shereen ; Ayoub, Bassam M ; Hassan, Mostafa A

Different simple spectrophotometric methods were developed for simultaneous determination of alogliptin and metformin manipulating their ratio spectra with successful application on recently approved combination, Kazano® tablets. Spiking was implemented to detect alogliptin in spite of its low contribution in the pharmaceutical formulation as low quantity in comparison to metformin. Linearity was acceptable over the concentration range of 2.5-25.0μg/mL and 2.5-15.0μg/mL for alogliptin and metformin, respectively using derivative ratio, ratio subtraction coupled with extended ratio subtraction and spectrum subtraction coupled with constant multiplication. The optimized methods were compared using one-way analysis of variance (ANOVA) and proved to be accurate for assay of the investigated drugs in their pharmaceutical dosage form.

2017-02-01·Die Pharmazie4区 · 医学

Comparative study between UHPLC-UV and UPLC-MS/MS methods for determination of alogliptin and metformin in their pharmaceutical combination.

4区 · 医学

Article

作者: Mowaka, S. ; Ayoub, B. M.

A new UPLC-MS/MS method (method A), for simultaneous determination of alogliptin (ALN) and metformin (MET) in their recently approved pharmaceutical combination Kazano® tablets, was developed and compared to a new UHPLC-UV method (method B). Concerning method A, separation was achieved on Hypersil gold 50 mm × 2.1 mm (1.9 μm) column, using acetonitrile and 0.2 % formic acid aqueous solution as the mobile phase with a gradient elution. Electrospray ionization (ESI) source was operated in positive ion mode. Selected reaction monitoring (SRM) mode on a triple quadropole mass spectrometer was used to quantify the drugs utilizing the transitions of 340.33 → 116.32 (m/z) and 130.12 → 71.32 (m/z) for ALN and MET, respectively. Concerning chromatographic separation using UV detection in method B, it was achieved on a Symmetry® C18 column 100 mm × 2.1 mm (2.2 μm) applying an isocratic elution based on methanol - water (10:90, v/v) at pH 3 as a mobile phase. The photodiode array detector was operated at 210 nm. Method A showed good linearity over the concentration ranges of 5-400 ng mL-1 and 25-2000 ng mL-1 for ALN and MET, respectively, while method B showed satisfactory results using ranges of 0.25-8 μg mL-1 and 5-50 μg mL-1 for ALN and MET, respectively. The optimized validated methods are suitable for QC labs but the UPLC-MS/MS method offered the advantage of shorter analytical times and higher sensitivity and selectivity.

2016-12-01·Die Pharmazie4区 · 医学

A guide for using experimental design in chromatographic method development: applied to the analysis of selected anti-diabetic pharmaceutical combinations.

4区 · 医学

Article

作者: Abdel-Aziz, O. ; Ayoub, B. M.

A guide experimental design in chromatographic method development was described and applied successfully to the analysis of different recently approved anti-diabetic pharmaceutical combinations. Enhancement of UHPLC analysis of alogliptin benzoate either with pioglitazone hydrochloride or with metformin hydrochloride was achieved. The optimal chromatographic conditions were not attained by trial and error that requires a large number of experiments. Alternatively, a computer program was used as a systematic optimization strategy for the design of the experiment which accurately predicts the combined effect of different factors simultaneously. Resolution between peaks was studied by the proposed fractional factorial design approach performed by the Minitab® Program using screening and optimization steps. Application of the central composite design was implemented. A Pareto chart was used to exclude the insignificant variables. Linearity ranges were found to be 0.5-40 μg ml-1, 1-20 μg ml-1 and 1-32 μg ml-1 for alogliptin benzoate, pioglitazone hydrochloride and metformin hydrochloride, respectively. The proposed method is applicable for the analysis of six pharmaceutical dosage forms namely, Nesina®, Actos®, Glucophage®, Oseni®, Kazano® and Actoplus MET® tablets.

项与苯甲酸阿格列汀/盐酸二甲双胍相关的新闻（医药）

2023-06-29

·CPHI制药在线

新药 | 逆天！仅2023上半年，恒瑞就有6个创新药申报上市

关注并星标CPHI制药在线最近这两年，国内不管是BigPharma、Biotech还是BioPharma，日子都不太好过。就连血厚的制药龙头恒瑞来说，2022年总营收以及归母净利润同比均下降明显。这里贴一组数据。 2022年，恒瑞总营收212.75亿元，同比下降17.87%。其中，创新药销售收入81.16亿元（含税86.13亿元）；归属于母公司所有者的净利润39.06亿元，同比下降13.77%；累计研发投入高达63.46亿元，较同期增长2.29%，研发投入占销售收入的比重同比提升至29.83%。穷则思变，在集采等多重buff下，布局、深耕创新药是摆脱困境的绝佳出路。截至目前，恒瑞共有12个创新药获批上市。但仅2023年上半年，恒瑞医药就递交了6个创新药的上市申请并获受理，这个数量在国内药企中可以说是一骑绝尘的。 2023年上半年，恒瑞报产创新药数量（资料来源：CDE官网，统计时间：2023.1.1-2023.6.28，若有不全处，欢迎留言补充）由上述表格中可以看出，这6个创新药中，化药和生物药各占一半。下面，我们来分别看一下，这几个药的作用机制、适应症和市场前景等如何。 01瑞格列汀二甲双胍片作用机制：DPP-4抑制剂/二甲双胍复方制剂适应症：2型糖尿病瑞格列汀二甲双胍片（Ⅰ）、瑞格列汀二甲双胍片（Ⅱ）是恒瑞自主研发的二肽基肽酶Ⅳ（DPP-4）抑制剂磷酸瑞格列汀与盐酸二甲双胍固定剂量复方制剂，用于经饮食运动治疗或经二甲双胍单药治疗血糖仍控制不佳的2型糖尿病患者。该产品通过两种不同作用机制达到降血糖的作用。同时，固定剂量复方制剂有望减少药物漏服，提高患者的治疗依从性。目前，国内外已有多个同类复方产品上市。国外方面，有默沙东的西格列汀二甲双胍片（商品名：捷诺达）、诺华的二甲双胍维格列汀片（商品名：宜合瑞）、礼来的利格列汀二甲双胍片（商品名：欧双宁）、武田制药的阿格列汀二甲双胍片（商品名：KAZANO）等；国内方面，南京优科制药有限公司的二甲双胍维格列汀片（商品名：万维乐）已经获批上市。糖尿病药物市场是仅次于肿瘤用药的第二大药品市场。相关数据显示，2021年，DPP-4抑制剂与二甲双胍复方制剂全球销售额约为119.32亿美元。 02SHR8058/SHR8028滴眼液作用机制：100%全氟己基辛烷适应症：干眼病 SHR8058滴眼液（又称NOV03）由100%全氟己基辛烷组成，能迅速扩散至整个眼表，并与泪膜的亲脂部分相互作用，覆盖在泪膜水液层表面，稳定泪膜、防止泪液过度蒸发。此外，SHR8058可穿透睑板腺，与腺体相互作用并溶解腺体中的粘性分泌物，从而达到治疗睑板腺功能障碍相关蒸发过强型干眼病的作用。 SHR8028滴眼液（又称CyclASol）是含有0.1%的环孢素A制剂，使用无水药物递送技术平台，局部生物利用度高，减少油性滴眼液导致的视力模糊，适用于水液缺乏型干眼症的治疗。 2019年11月，恒瑞医药从Novaliq引进SHR8058、SHR8028，获得其在中国的临床开发、生产和市场销售的独家权利。根据灼识资料，预计全球眼科药物市场将由2019年的340亿美元增至2030年的681亿美元。 03夫那奇珠单抗注射液作用机制：IL-17单抗适应症：中重度斑块状银屑病夫那奇珠单抗注射液（vunakizumab，研发代号：SHR-1314）是恒瑞医药研发的一种靶向人IL-17A的重组人源化单克隆抗体，拟用于治疗与IL-17通路相关的自身免疫疾病。目前，国内外均有IL-17抑制剂获批上市。2022年，诺华的司库奇尤单抗销售额为47.88亿美元，礼来的依奇珠单抗销售额也有24.82亿美元，二者合计年度销售金额超过72亿美元。这两款药物均已进入中国，但是还未有国产IL-17抑制剂上市。但值得注意的是，创响生物引进的IMG-020注射液、智翔金泰的赛立奇单抗注射液、优时比（UCB）的比吉利珠单抗注射液均在2023年上半年递交上市申请，这些均可以算是夫那奇珠单抗注射液的竞品。 04硫酸艾玛昔替尼片作用机制：JAK1抑制剂适应症：特应性皮炎艾玛昔替尼片（研发代号：SHR0302）是恒瑞子公司瑞石生物研发的高选择性的JAK1抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物学效应，也是首个在自免疾病治疗领域获得关键III期研究成功的国产JAK1抑制剂。目前，全球共有3款JAK1抑制剂获批，分别是艾伯维的乌帕替尼缓释片（商品名：瑞福）、吉利德的非戈替尼片和辉瑞的阿布昔替尼片（商品名：希必可）。其中，阿布昔替尼和乌帕替尼用于治疗特应性皮炎。尚未有国产JAK1抑制剂获批上市。值得一提的是，2022年10月，泽璟制药的盐酸杰克替尼片递交上市申请，但适应症为骨髓纤维化。此外，信达生物的Itacitinib也已处于III期研究阶段。迪哲医药、药明康德、科伦药业、凌科药业、高光制药等也在研发JAK抑制剂。 2021年阿布昔替尼和乌帕替尼缓释全球销售额分别为600万美元和16.51亿美元。据弗若斯特沙利文预测，国内JAK1抑制剂将持续快速增长，2024年、2030年市场规模将分别达到100亿、481亿元人民币，2019-2024年复合增长率达到92.2%。 05注射用瑞卡西单抗作用机制：PCSK9单抗适应症：高胆固醇血症瑞卡西单抗（Recaticimab、研发代号：SHR-1209）是恒瑞医药开发的一款抗PCSK9单抗，该药可通过与循环中的PCSK9结合，增加肝细胞表面LDLR的表达，促进LDL-C清除，从而达到降低血清LDL-C水平的目的。目前，全球共有2款PCSK9单抗药物获批，分别是安进的依洛尤单抗（商品名：瑞百安）和赛诺菲/再生元的阿利西尤单抗（商品名：波立达）。2022年，2款药物销售额分别为12.96亿美元、4.04亿美元。这两款药物均已在国内获批。小干扰RNA药物inclisran也是PCSK9靶向药。此外，共有4款国产PCSK9单抗递交上市申请，分别是信达生物的托莱西单抗、君实生物的JS002、康方生物的伊努西单抗以及恒瑞的注射用瑞卡西单抗。肿瘤、麻醉以及造影剂一直是恒瑞的基本盘，但是很明显的是，制药龙头在寻找下一个增长引擎，不管是糖尿病还是干眼病或者是自身性免疫疾病等，在如此多的创新药储备下，笔者相信，很快会有新的增长引擎出现。【企业推荐】智药研习社近期课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准财报

100 项与苯甲酸阿格列汀/盐酸二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD13	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	美国	Takeda Pharmaceuticals U.S.A., Inc.	2013-01-25

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02276274 (CTgov)	临床3期	-	12	SYR-322-MET (SYR-322-MET Fasted)	築積齋選襯觸糧遞顧繭(壓夢壓鏇獵構膚蓋衊鹹) = 壓鬱蓋壓觸蓋廠糧觸餘憲壓遞願製壓遞膚夢廠 (顧積鹹鑰鬱觸膚構鏇壓, 繭糧餘淵糧壓窪獵獵築 ~ 獵餘遞網糧淵壓餘鹽衊) 更多	-	2015-06-29
				SYR-322-MET (SYR-322-MET Fed)	築積齋選襯觸糧遞顧繭(壓夢壓鏇獵構膚蓋衊鹹) = 蓋簾獵襯醖鏇顧願選蓋憲壓遞願製壓遞膚夢廠 (顧積鹹鑰鬱觸膚構鏇壓, 餘繭範築願鑰憲憲壓製 ~ 廠窪鹹繭醖糧壓夢鹽網) 更多