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更新于：2026-08-20
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-08-20
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
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C33H30N4O2 |
InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N |
CAS号144701-48-4 |
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关联
91
项与 苯磺酸氨氯地平/替米沙坦 相关的临床试验IRCT20240804062647N24
In-vivo bioequivalence study of Amlodipine 10 mg-Telmisartan 80 mg tablet of the test drug manufactured by Actoverco pharmacutical company in compared with the reference drug Twynsta 10-80 mg tablet
CTR20250121
替米沙坦氨氯地平片在健康参与者中的单中心、随机、开放、单次给药、两制剂、四周期、两序列、完全重复交叉空腹及餐后状态下生物等效性研究
CTR20244151
替米沙坦氨氯地平片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、三序列、三周期交叉生物等效性研究
100 项与 苯磺酸氨氯地平/替米沙坦 相关的临床结果
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的转化医学
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的专利（医药）
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6
项与 苯磺酸氨氯地平/替米沙坦 相关的文献（医药）2025-02-01JOURNAL OF PHARMACEUTICAL SCIENCES
The impact of volume of dissolution medium for biopredictive dissolution/permeation studies of enabling formulations: A comparison of two brands of telmisartan / amlodipine tablets
Article
作者: Brandl, Martin ; Milsmann, Johanna ; Bauer-Brandl, Annette ; Eriksen, Jonas Borregaard
For compendial dissolution testing of solid dosage forms, media volumes of 500 to 900 mL are used in apparatus I and II to ensure sink conditions. However, these volumes are considerably larger than those in the gastrointestinal tract. Thus, the experiments are not biomimetic and possibly not suitable for biopredictive dissolution testing. The present study investigates the influence of volumes of dissolution media in non-compendial dissolution/permeation settings. Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Particularly, the two-stage dissolution process of telmisartan from the tablets is interesting because the compound has a pH-dependent solubility, and 2-stage dissolution leads to supersaturation and precipitation upon pH shift. For telmisartan, lower dissolution volumes significantly induced precipitation, leading to lower permeation, while no precipitation was observed in the larger volume. The permeation of telmisartan was overly sensitive to both pH and micelle concentrations in the biomimetic media. Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems.
2020-10-01Journal of clinical hypertension (Greenwich, Conn.)3区 · 医学
Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia
3区 · 医学
Article
作者: Cho, Jin‐Man ; Kim, Hyungseop ; Sung, Ki Chul ; Hwang, Jinyong ; Yoo, Byung Su ; Lee, Jae‐Hwan ; Kim, Pum‐Joon ; Shin, Jin Ho ; Lee, Sang Hyun ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Kim, Woo‐Shik ; Chae, In‐Ho ; Hong, Seung Pyo ; Kim, Ju Han ; Choi, So‐Yeon ; Kim, Moo Hyun ; Kim, Hyo‐Soo ; Hong, Soon Jun ; Kwon, Kihwan ; Lee, Kyounghoon ; Cho, Yoonhwa ; Jin, Xuan ; Rhee, Moo‐Yong ; Lee, Hana ; Han, Ki Hoon ; Park, Chang‐Gyu ; Lee, Han Cheol ; Cho, Eun Joo ; Seo, Jeong‐Sook ; Hyon, Min Su
Abstract:
Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were −52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (−55.13 (3.20) %, 95% CI −61.45 to −48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.
2019-04-01Clinical therapeutics
Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study
Article
作者: Byung-Su Yoo ; Seung-Woon Rha ; Kye-Hoon Kim ; Moo-Yong Rhee ; Ki-Chul Sung ; Ki-Dong Yoo ; Sang-Ho Park ; Seok-Yeon Kim ; Dae-Gyun Park ; Jeong-Cheon Ahn ; Dong-Woon Jeon ; Young-Won Yoon ; Yong-Jin Kim ; Han-Cheol Lee ; Tae-Seok Kim ; Sang-Kyoon Cho ; Myung-Ho Yoon ; Dong-Hun Cha ; Yong-Seog Oh ; Woo-Sik Kim
PURPOSE:
Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.
METHODS:
In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG.
FINDINGS:
A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups.
IMPLICATIONS:
Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.
100 项与 苯磺酸氨氯地平/替米沙坦 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 |
|---|---|---|---|
| 原发性高血压 | 韩国 | 2010-08-19 | |
| 心脏衰竭 | 美国 | 2009-10-16 | |
| 高血压 | 美国 | 2009-10-16 | |
| 心肌梗塞 | 美国 | 2009-10-16 | |
| 肾功能不全 | 美国 | 2009-10-16 | |
| 脑卒中 | 美国 | 2009-10-16 | |
| 视觉障碍 | 美国 | 2009-10-16 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性高血压 | 临床3期 | 比利时 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 加拿大 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 丹麦 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 芬兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 法国 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 荷兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 挪威 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 菲律宾 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 南非 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 韩国 | 2007-10-01 |
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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 | 202 | 選衊願願鬱夢獵衊艱簾(憲網選積艱壓觸憲廠積) = 繭鏇憲積鹹繭淵廠鑰選 顧選構鬱窪鹽齋顧窪繭 (願簾廠鑰範膚繭願齋鹽 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 選衊願願鬱夢獵衊艱簾(憲網選積艱壓觸憲廠積) = 築夢鬱網夢醖憲製觸顧 顧選構鬱窪鹽齋顧窪繭 (願簾廠鑰範膚繭願齋鹽 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 窪鹹獵蓋範鬱醖築範壓(壓製衊網選願簾艱鹹選) = 艱構鹹憲鏇獵製範淵網 齋窪觸製構糧簾齋獵範 (簾餘築淵遞觸鏇範糧獵 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 窪鹹獵蓋範鬱醖築範壓(壓製衊網選願簾艱鹹選) = 壓夢願願鬱範範齋選鹽 齋窪觸製構糧簾齋獵範 (簾餘築淵遞觸鏇範糧獵 ) | ||||||
临床4期 | 64 | 繭範繭構鏇觸築夢襯鬱(觸淵積齋製餘餘夢鹹夢) = 膚積遞醖衊蓋遞觸壓網 獵構鏇繭積製衊鹽鏇觸 (艱築網鬱醖繭壓鑰範積, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 繭範繭構鏇觸築夢襯鬱(觸淵積齋製餘餘夢鹹夢) = 鬱膚壓網範積窪憲鹹鬱 獵構鏇繭積製衊鹽鏇觸 (艱築網鬱醖繭壓鑰範積, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 觸鑰夢網鑰築壓糧憲鏇(艱糧糧積顧願醖艱鏇餘) = 醖築糧廠築夢觸鹹膚壓 鬱襯積艱鹽網選範範積 (網齋憲齋鏇構鏇繭艱齋, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 願齋壓夢獵餘選壓廠餘(願壓齋網齋製艱鏇獵淵) = 積鑰鏇艱獵醖糧簾製製 構選選顧淵襯製衊醖壓 (鬱襯鬱壓積窪衊憲鹽顧, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 願齋壓夢獵餘選壓廠餘(願壓齋網齋製艱鏇獵淵) = 願鹽遞鹹襯膚製選繭繭 構選選顧淵襯製衊醖壓 (鬱襯鬱壓積窪衊憲鹽顧, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 鑰獵糧壓鑰膚鬱餘顧窪(窪艱憲網憲衊夢窪構繭) = 製製醖廠繭齋繭廠夢顧 選壓艱鹽繭範鏇網遞遞 (願膚壓鬱築鑰鏇願糧遞, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 鹹壓遞遞糧網遞齋窪淵 = 鹹選選網構鏇願鑰艱鹽 糧鹽築製獵餘願鹽觸襯 (築選範壓選襯鹽鹽淵鹽, 艱蓋糧簾鹹壓鹹積壓憲 ~ 衊餘襯廠顧淵鬱鑰構構) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 夢選鹹蓋鏇鹽糧獵願窪(鹽襯鏇壓齋鹹餘範鏇遞) = 選選醖遞積製遞糧餘獵 顧衊夢顧繭顧廠憲鏇繭 (積構鹹壓範獵鹹鹹積餘, 餘範繭願鹹壓範蓋鬱衊 ~ 鬱顧遞襯繭襯鏇夢繭選) 更多 | ||||||
临床3期 | 174 | 製築艱願壓壓顧淵夢鹹(艱衊膚積築繭鬱構淵艱) = 壓淵餘築壓廠鹹選鏇築 積繭壓醖壓壓夢鹹鑰構 (糧艱蓋艱襯醖願醖廠築, 0.73) 更多 | - | 2012-07-04 | |||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 壓構窪壓範觸鑰構選繭(餘選糧衊鏇衊鹹選艱積) = 獵繭衊憲糧淵蓋膚選淵 鏇願積膚膚網製襯繭構 (選壓觸觸積廠鏇簾膚膚, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 壓構窪壓範觸鑰構選繭(餘選糧衊鏇衊鹹選艱積) = 廠構鹹願製襯觸築壓網 鏇願積膚膚網製襯繭構 (選壓觸觸積廠鏇簾膚膚, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 壓網餘糧鑰齋襯鬱鹹鹹(齋齋淵窪網製膚醖選襯) = 憲艱鹹壓願製築鏇構艱 壓網糧遞顧願鏇憲壓鬱 (壓糧餘襯醖鏇鬱衊夢衊, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 壓網餘糧鑰齋襯鬱鹹鹹(齋齋淵窪網製膚醖選襯) = 繭鏇廠艱選構願夢簾積 壓網糧遞顧願鏇憲壓鬱 (壓糧餘襯醖鏇鬱衊夢衊, 66.1935) 更多 |
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