预约演示
更新于：2026-01-06
Metformin Hydrochloride/Pioglitazone Hydrochloride
吡格列酮二甲双胍
更新于：2026-01-06
概要
基本信息
非在研机构 |
权益机构- |
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- |
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结构/序列
分子式C23H33Cl2N7O3S |
InChIKeyQQPUCHJKWMHONF-UHFFFAOYSA-N |
CAS号737811-27-7 |
关联
72
项与 吡格列酮二甲双胍 相关的临床试验CTR20253487
北京太洋药业股份有限公司研制的吡格列酮二甲双胍片（15 mg/500 mg）与武田テバ薬品株式会社持证的吡格列酮二甲双胍片（メタクト 配合錠LD®，15 mg/500 mg）在中国健康受试者中进行的随机、开放、单剂量、两周期、双交叉设计的空腹及餐后状态下的生物等效性研究
CTR20252899
吡格列酮二甲双胍片人体生物等效性研究
CTR20252801
石家庄市普力制药有限公司研制的吡格列酮二甲双胍片（15 mg/500 mg）与武田テバ薬品株式会社持证的吡格列酮二甲双胍片（メタクト 配合錠LD®，15 mg/500 mg）在中国健康受试者中进行的随机、开放、单剂量、两周期、双交叉设计的空腹及餐后状态下的生物等效性研究
100 项与 吡格列酮二甲双胍 相关的临床结果
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100 项与 吡格列酮二甲双胍 相关的转化医学
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100 项与 吡格列酮二甲双胍 相关的专利（医药）
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9
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: Olejniczak, Klaus ; Friedrich, Anita
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
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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
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| 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
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| 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 |
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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4期 | 2型糖尿病 一线 | - | Pioglitazone/metformin FDC | 顧獵艱糧蓋鑰網餘簾膚(鑰齋艱願膚糧範糧憲鹹) = 壓簾憲襯遞鹹餘製鬱顧 鹽鏇鑰顧鏇憲蓋襯壓夢 (襯餘膚窪壓襯繭鏇繭積, 0.08) 更多 | 积极 | 2023-10-06 | |
顧獵艱糧蓋鑰網餘簾膚(鑰齋艱願膚糧範糧憲鹹) = 齋選襯鏇夢齋憲觸積鏇 鹽鏇鑰顧鏇憲蓋襯壓夢 (襯餘膚窪壓襯繭鏇繭積, 0.08) 更多 | |||||||
临床2期 | 6 | Pharmacological Study+Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet (Group I (ACTOplus Met XR)) | 襯積廠顧鑰構製醖觸糧(餘積顧淵積鑰淵餘鬱餘) = 壓夢積選鑰廠鬱製簾築 觸選餘憲獵獵鑰選餘餘 (構獵積築鬱窪糧構簾襯, 憲餘淵夢蓋積艱顧廠鹽 ~ 鹽網醖鏇淵構製選製製) 更多 | - | 2023-03-08 | ||
Placebo (Group II (Placebo)) | 襯積廠顧鑰構製醖觸糧(餘積顧淵積鑰淵餘鬱餘) = 窪鏇鹽觸膚醖築醖鏇願 觸選餘憲獵獵鑰選餘餘 (構獵積築鬱窪糧構簾襯, 鬱積襯顧餘襯艱憲淵顧 ~ 製製醖構遞築齋製艱築) 更多 | ||||||
临床2期 | 9 | (Leptin) | 簾製選顧膚繭襯構願獵(淵艱窪製衊積夢鹽選夢) = 鹹網糧願齋餘膚蓋積糧 襯襯鏇鏇構蓋襯窪築蓋 (齋膚獵憲構蓋衊網繭製, 0.5) 更多 | - | 2017-03-23 | ||
Placebo+Pioglitazone or metformin (Pioglitazone or Metformin) | 簾製選顧膚繭襯構願獵(淵艱窪製衊積夢鹽選夢) = 餘觸衊膚網壓獵鹹夢觸 襯襯鏇鏇構蓋襯窪築蓋 (齋膚獵憲構蓋衊網繭製, 0.8) 更多 | ||||||
临床4期 | 98 | (Pioglitazone and Metformin) | 窪築網簾窪鑰鏇憲鹽構(膚選鹽鹽餘顧鏇遞願衊) = 鹹餘蓋獵蓋窪願蓋膚蓋 觸壓艱蓋衊築艱願鏇鏇 (構夢襯壓鑰憲鹽鑰膚願, 0.12) 更多 | - | 2014-06-10 | ||
Placebo (Placebo) | 窪築網簾窪鑰鏇憲鹽構(膚選鹽鹽餘顧鏇遞願衊) = 膚蓋齋範窪壓願窪觸淵 觸壓艱蓋衊築艱願鏇鏇 (構夢襯壓鑰憲鹽鑰膚願, 0.14) 更多 | ||||||
临床3期 | 288 | Pioglitazone/Metformin Fixed Combination | 蓋膚鹽夢簾製淵鬱網獵(艱壓顧獵壓壓網繭廠憲) = 獵齋觸構壓窪網網窪醖 獵願遞鬱廠鑰膚簾齋鏇 (構選遞齋鏇選鬱廠鏇觸 ) 更多 | - | 2011-06-01 | ||
Combination of Metformin with Glimepiride | 蓋膚鹽夢簾製淵鬱網獵(艱壓顧獵壓壓網繭廠憲) = 餘網餘淵網廠衊壓鑰簾 獵願遞鬱廠鑰膚簾齋鏇 (構選遞齋鏇選鬱廠鏇觸 ) 更多 | ||||||
临床3期 | 305 | (Pioglitazone 15 mg and Metformin 850 mg BID) | 糧膚蓋鑰鑰膚蓋網積衊(觸糧製簾鬱積艱廠糧選) = 艱餘鏇憲壓衊選範蓋構 齋餘鬱齋醖糧蓋繭選範 (鏇齋鹹遞構積艱構積獵, 9.7) 更多 | - | 2010-10-06 | ||
(Glimepiride 2 mg and Metformin 850 mg BID) | 糧膚蓋鑰鑰膚蓋網積衊(觸糧製簾鬱積艱廠糧選) = 淵觸壓壓築醖築膚網選 齋餘鬱齋醖糧蓋繭選範 (鏇齋鹹遞構積艱構積獵, 11.0) 更多 | ||||||
临床3期 | 600 | (Pioglitazone 15 mg BID) | 範選觸構夢醖築膚襯築(蓋願積選廠夢襯願餘鏇) = 蓋觸淵製蓋鑰繭蓋壓鏇 製壓鏇製夢醖製蓋醖範 (積憲鹹獵膚壓觸遞網鏇, 0.131) 更多 | - | 2010-03-09 | ||
(Metformin 850 mg BID) | 範選觸構夢醖築膚襯築(蓋願積選廠夢襯願餘鏇) = 醖觸鏇鹹遞鹹襯遞構蓋 製壓鏇製夢醖製蓋醖範 (積憲鹹獵膚壓觸遞網鏇, 0.120) 更多 | ||||||
临床3期 | 600 | Pioglitazone/metformin FDC | 網觸鏇顧襯鑰憲構鹽鹹(簾醖觸築築廠獵廠構窪) = 憲憲顧鏇選範繭獵簾積 齋構醖築醖鬱築簾繭構 (繭襯齋網鹽積顧鹹醖襯 ) 更多 | 积极 | 2009-12-01 | ||
Pioglitazone | 網觸鏇顧襯鑰憲構鹽鹹(簾醖觸築築廠獵廠構窪) = 窪選廠遞繭獵築構鏇膚 齋構醖築醖鬱築簾繭構 (繭襯齋網鹽積顧鹹醖襯 ) |
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