预约演示
更新于：2025-04-11
Metformin Hydrochloride/Pioglitazone Hydrochloride
吡格列酮二甲双胍
更新于：2025-04-11
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-08-29), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C23H33Cl2N7O3S |
InChIKeyQQPUCHJKWMHONF-UHFFFAOYSA-N |
CAS号737811-27-7 |
关联
57
项与 吡格列酮二甲双胍 相关的临床试验CTR20244521
吡格列酮二甲双胍片在健康受试者中空腹/餐后、单剂量口服、随机、开放、两制剂、两周期生物等效性研究
CTR20244295
吡格列酮二甲双胍片在健康受试者中单剂量口服、随机、开放、两制剂、两周期生物等效性研究
CTR20244046
吡格列酮二甲双胍片人体生物等效性研究
100 项与 吡格列酮二甲双胍 相关的临床结果
登录后查看更多信息
100 项与 吡格列酮二甲双胍 相关的转化医学
登录后查看更多信息
100 项与 吡格列酮二甲双胍 相关的专利（医药）
登录后查看更多信息
10
项与 吡格列酮二甲双胍 相关的文献（医药）2017-01-01Journal of clinical medicine research
Effect of Switching From an Anti-Diabetic Loose Dose Combination to a Fixed Dose Combination Regimen at Equivalent Dosage for 6 Months on Glycemic Control in Japanese Patients With Type 2 Diabetes: A Pilot Study
Article
作者: Kamiyama, Hiroshi ; Oka, Masanao ; Masumura, Makoto ; Aoki, Kazutaka ; Nagakura, Mieko ; Akema, Noriko ; Taguri, Masataka ; Furuie, Tadashi ; Terauchi, Yasuo ; Nakajima, Shigeru ; Kamiko, Kazunari
BACKGROUND:
Patients with type 2 diabetes mellitus often take multiple anti-diabetic drugs for a long period. Fixed dose combination (FDC) therapy is expected to improve drug adherence for patients with diabetes. The effect of switching from a loose dose combination (LDC) regimen to an FDC regimen at equivalent dosage on glycemic control has not been evaluated fully. Therefore, we investigated the effect of switching from LDC to FDC at equivalent dosage for 6 months on glycemic control in Japanese patients with type 2 diabetes.
METHODS:
Thirty-eight Japanese patients with type 2 diabetes who were taking anti-diabetic drugs including pioglitazone + metformin, pioglitazone + alogliptin, or pioglitazone + glimepiride were enrolled. These drugs were switched to an FDC of Metact®, Liobel® or Sonias®, respectively, at equivalent dosage. Other anti-diabetic drugs and units of insulin were not changed during the study if possible. HbA1c and body weight were measured 0, 2, 4 and 6 months after switching from an LDC to FDC. We also conducted a questionnaire survey 2 months after the start of the FDC regimen.
RESULTS:
HbA1c levels at 2, 4, and 6 months were not significantly changed compared with prior to switching from an LDC to FDC regimen. Moreover, 74.2% of patients considered decreasing the number of drugs to be "very good" or "good".
CONCLUSION:
HbA1c levels did not differ between patients receiving LDC and FDC therapy at equivalent dosage in this study.
2016-12-01Die 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.
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: Klaus Olejniczak ; Anita Friedrich
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 吡格列酮二甲双胍 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 感染 | 美国 | 2009-05-12 | |
| 体重下降 | 美国 | 2009-05-12 | |
| 2型糖尿病 | 美国 | 2005-08-29 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血脂障碍 | 临床3期 | 德国 | 2007-04-01 | |
| 代谢综合征 | 临床3期 | - | 2007-01-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 98 | (Pioglitazone and Metformin) | 艱獵鑰壓餘獵觸窪蓋壓(製製築獵憲鏇獵夢窪齋) = 鹹觸淵蓋繭醖壓構餘餘 壓糧製鏇獵襯鑰鹽獵鏇 (觸淵蓋繭顧夢構選廠範, 0.12) 更多 | - | 2014-06-10 | ||
Placebo (Placebo) | 艱獵鑰壓餘獵觸窪蓋壓(製製築獵憲鏇獵夢窪齋) = 醖觸鹽蓋餘廠廠網繭構 壓糧製鏇獵襯鑰鹽獵鏇 (觸淵蓋繭顧夢構選廠範, 0.14) 更多 | ||||||
临床3期 | 305 | (Pioglitazone 15 mg and Metformin 850 mg BID) | 壓繭醖夢鹽憲壓艱網襯(製製齋簾簾構範製鬱遞) = 鏇蓋醖簾廠鑰積淵餘築 襯築築廠願鹽壓築膚鬱 (願膚願獵鹽齋襯鏇壓壓, 9.7) 更多 | - | 2010-10-06 | ||
(Glimepiride 2 mg and Metformin 850 mg BID) | 壓繭醖夢鹽憲壓艱網襯(製製齋簾簾構範製鬱遞) = 淵網襯壓鹽鏇鹽鏇蓋鏇 襯築築廠願鹽壓築膚鬱 (願膚願獵鹽齋襯鏇壓壓, 11.0) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用