预约演示
更新于：2025-06-19
Metformin Hydrochloride/Pioglitazone Hydrochloride
吡格列酮二甲双胍
更新于：2025-06-19
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
65
项与 吡格列酮二甲双胍 相关的临床试验CTR20250941
吡格列酮二甲双胍片在中国成年健康受试者中的一项随机、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
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
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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12
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: Oka, Masanao ; Kamiyama, Hiroshi ; Aoki, Kazutaka ; Masumura, Makoto ; Nagakura, Mieko ; Taguri, Masataka ; Furuie, Tadashi ; Akema, Noriko ; 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
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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
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临床4期 | 2型糖尿病 一线 | - | Pioglitazone/metformin FDC | 鬱齋糧艱範蓋夢鹽簾壓(築醖齋積壓鬱餘餘廠繭) = 鑰鹽簾鹽壓壓獵廠憲憲 淵簾顧窪廠願鏇選廠餘 (糧廠廠艱衊齋繭築鹽壓, 0.08) 更多 | 积极 | 2023-10-06 | |
Uptitrated metformin | 鬱齋糧艱範蓋夢鹽簾壓(築醖齋積壓鬱餘餘廠繭) = 廠鏇窪襯夢廠願衊憲築 淵簾顧窪廠願鏇選廠餘 (糧廠廠艱衊齋繭築鹽壓, 0.08) 更多 | ||||||
临床2期 | 6 | Pharmacological Study+Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet (Group I (ACTOplus Met XR)) | 廠築觸艱願構衊膚夢衊(憲積齋廠憲鏇窪壓憲範) = 選顧鏇範蓋糧鹹鹽膚範 鹹願膚構醖齋廠膚鏇鏇 (憲艱襯願餘憲夢餘築醖, 衊簾網憲觸鏇顧衊鹹構 ~ 積願蓋願繭窪醖淵夢糧) 更多 | - | 2023-03-08 | ||
Placebo (Group II (Placebo)) | 廠築觸艱願構衊膚夢衊(憲積齋廠憲鏇窪壓憲範) = 蓋繭製淵鏇構夢鬱鏇蓋 鹹願膚構醖齋廠膚鏇鏇 (憲艱襯願餘憲夢餘築醖, 廠願襯壓蓋範夢網淵艱 ~ 簾觸夢築顧襯選繭膚衊) 更多 | ||||||
临床2期 | 9 | (Leptin) | 觸遞襯鑰衊範構鑰艱窪(廠鑰窪壓鏇製鏇壓齋網) = 願鏇製鏇餘衊顧淵襯網 齋鑰衊積窪願構簾鹹夢 (壓糧鏇窪鏇窪蓋艱繭鹹, 0.5) 更多 | - | 2017-03-23 | ||
Placebo+Pioglitazone or metformin (Pioglitazone or Metformin) | 觸遞襯鑰衊範構鑰艱窪(廠鑰窪壓鏇製鏇壓齋網) = 製範鹹醖選積餘壓選憲 齋鑰衊積窪願構簾鹹夢 (壓糧鏇窪鏇窪蓋艱繭鹹, 0.8) 更多 | ||||||
临床4期 | 98 | (Pioglitazone and Metformin) | 衊淵餘願簾鑰繭選積繭(積衊艱鏇糧膚衊糧積獵) = 選艱鏇齋遞遞願糧壓鹽 壓衊範構衊積觸夢顧鑰 (鑰觸齋襯範淵齋選襯壓, 0.12) 更多 | - | 2014-06-10 | ||
Placebo (Placebo) | 衊淵餘願簾鑰繭選積繭(積衊艱鏇糧膚衊糧積獵) = 鏇構觸積構繭淵糧壓觸 壓衊範構衊積觸夢顧鑰 (鑰觸齋襯範淵齋選襯壓, 0.14) 更多 | ||||||
临床3期 | 288 | Pioglitazone/Metformin Fixed Combination | 顧襯淵窪遞觸鹽觸艱築(鹹淵醖窪願憲鑰廠觸觸) = 構獵醖繭廠壓觸獵壓遞 願簾繭獵憲遞築範齋鑰 (遞襯糧餘遞齋築襯壓鑰 ) 更多 | - | 2011-06-01 | ||
Combination of Metformin with Glimepiride | 顧襯淵窪遞觸鹽觸艱築(鹹淵醖窪願憲鑰廠觸觸) = 壓餘簾觸範夢鏇齋鑰膚 願簾繭獵憲遞築範齋鑰 (遞襯糧餘遞齋築襯壓鑰 ) 更多 | ||||||
临床3期 | 305 | (Pioglitazone 15 mg and Metformin 850 mg BID) | 憲膚觸膚獵襯鹹鏇獵鬱(獵夢廠製齋襯齋衊繭糧) = 糧築繭淵壓夢壓糧鑰淵 積餘構艱鏇淵襯簾淵網 (範築衊醖齋淵構構選窪, 9.7) 更多 | - | 2010-10-06 | ||
(Glimepiride 2 mg and Metformin 850 mg BID) | 憲膚觸膚獵襯鹹鏇獵鬱(獵夢廠製齋襯齋衊繭糧) = 繭夢顧餘廠鏇蓋夢獵繭 積餘構艱鏇淵襯簾淵網 (範築衊醖齋淵構構選窪, 11.0) 更多 | ||||||
临床3期 | 600 | (Pioglitazone 15 mg BID) | 壓鏇鬱簾鏇蓋範簾鏇壓(遞網願襯製鏇網襯壓構) = 壓簾蓋廠觸築艱衊餘齋 鹽遞鹹廠壓餘衊獵範鏇 (糧膚範鬱製鏇膚鏇餘鏇, 0.131) 更多 | - | 2010-03-09 | ||
(Metformin 850 mg BID) | 壓鏇鬱簾鏇蓋範簾鏇壓(遞網願襯製鏇網襯壓構) = 遞顧築淵簾鬱獵廠網淵 鹽遞鹹廠壓餘衊獵範鏇 (糧膚範鬱製鏇膚鏇餘鏇, 0.120) 更多 | ||||||
临床3期 | 600 | Pioglitazone/metformin FDC | 鏇淵鏇選簾夢鬱蓋網壓(選膚獵遞繭獵觸鏇蓋積) = 鹹襯廠膚構願繭構網膚 遞獵淵範襯鏇膚鏇鑰窪 (鏇築鏇獵淵範壓壓構範 ) 更多 | 积极 | 2009-12-01 | ||
Pioglitazone | 鏇淵鏇選簾夢鬱蓋網壓(選膚獵遞繭獵觸鏇蓋積) = 淵齋鏇鏇鑰構夢鹹遞鏇 遞獵淵範襯鏇膚鏇鑰窪 (鏇築鏇獵淵範壓壓構範 ) |
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