主要研究目的：以江苏亚邦爱普森药业有限公司研制的替米沙坦氨氯地平片（规格：40 mg/5 mg）为受试制剂，按生物等效性研究的有关规定，与Boehringer Ingelheim International GmbH持证的替米沙坦氨氯地平片（参比制剂，商品名：Twynsta®，规格：40 mg/5 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在健康参与者中的安全性。

开始日期2025-02-18

申办/合作机构

江苏亚邦爱普森药业有限公司

CTR20244151

/ CompletedN/A

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

主要研究目的：考察单次口服（空腹/餐后）受试制剂替米沙坦氨氯地平片（规格：80mg/5mg，海南赛立克药业有限公司生产，海南赛立克药业有限公司提供）与参比制剂替米沙坦氨氯地平片（Twynsta®，规格：80mg/5mg，Boehringer Ingelheim International GmbH持证，海南赛立克药业有限公司提供）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态下口服两种制剂的生物等效性。次要研究目的：评价受试制剂和参比制剂单次口服（空腹/餐后）在中国成年健康受试者中的安全性。

开始日期2024-11-30

申办/合作机构

海南赛立克药业有限公司

CTR20241713

/ CompletedN/A

替米沙坦氨氯地平片(80mg/5mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Boehringer Ingelheim International GmbH为持证商的替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）为参比制剂，对吉林省德商药业股份有限公司生产和持证的受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）和参比制剂替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）的安全性。

开始日期2024-06-17

申办/合作机构

吉林省德商药业股份有限公司

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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项与苯磺酸氨氯地平/替米沙坦相关的文献（医药）

2025-02-01·JOURNAL 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.

2020-10-01·Journal 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 ; Lee, Sang Hyun ; Shin, Jin Ho ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Chae, In‐Ho ; Hong, Seung Pyo ; Kim, Woo‐Shik ; 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 ; Park, Chang‐Gyu ; Lee, Hana ; Han, Ki Hoon ; 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.

2019-04-01·Clinical 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: Rhee, Moo-Yong ; Yoo, Ki-Dong ; Cho, Sang-Kyoon ; Kim, Kye-Hoon ; Park, Sang-Ho ; Yoo, Byung-Su ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Ahn, Jeong-Cheon ; Park, Dae-Gyun ; Kim, Seok-Yeon ; Cha, Dong-Hun ; Rha, Seung-Woon ; Oh, Yong-Seog ; Sung, Ki-Chul ; Yoon, Young-Won ; Kim, Yong-Jin ; Yoon, Myung-Ho ; Jeon, Dong-Woon

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.

项与苯磺酸氨氯地平/替米沙坦相关的新闻（医药）

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-22

·米内网

【火热】施美药业新药来袭，抢食1000亿市场

精彩内容近日，江西施美药业的JSS-222获批临床，用于治疗精神分裂症。今年以来，该公司已有4款新药获批临床，其中JSS-221和JSS-222为神经系统新药。2024年在中国三大终端六大市场，神经系统药物（化+生）的销售规模达到了1050亿元。据米内网统计，江西施美药业已有15款新药申报临床。图1：江西施美药业最新获批临床的新药来源：CDE官网表1：江西施美药业申报的新药情况来源：米内网数据库、公司公开资料整理米内网数据显示，目前江西施美药业已申报了15款新药，均为化药2类（含2.2、2.3）。11款已获批临床的新药中，有9款用于治疗高血压，而JSS-221和JSS-222则用于治疗成人抑郁症、精神分裂症。江西施美药业正积极加强创新研发，目前集中火力抢食心脑血管系统药物和神经系统药物两大千亿市场。在中国三大终端六大市场（统计范围见文末），神经系统药物（化+生）的销售规模在2020-2024年保持在1000亿元水平，虽有跌宕起伏的态势，但市场空间依然巨大；心脑血管系统药物（化+生）的销售规模在2021-2024年保持在1300亿元水平，但2023-2025年Q1连续负增长，市场持续承压。表2：江西施美药业近两年获批的神经系统药物来源：米内网中国申报进度（MED）数据库 2000年以前，江西施美药业在神经系统药物市场已有老产品贝诺酯胶囊（止痛药）和维磷颗粒（精神兴奋药），2024年至今公司在该大类市场陆续获批了6款新品。截至目前，公司在神经系统药物市场拥有1个麻醉剂、1个精神安定药、3个精神兴奋药、2个止痛药、1个抗癫痫药。目前，江西施美药业在神经系统药物市场暂无新品报产在审，JSS-221和JSS-222两款新药后续将助力公司提升竞争力。表3：江西施美药业已获批的心脑血管系统化药来源：米内网中国申报进度（MED）数据库 2008年，江西施美药业的苯磺酸左旋氨氯地平片获批，标志着公司成功进入心脑血管系统药物市场。近几年，公司持续深耕该药物市场，并持续有新品获批，目前公司已有8款高血压用药上市。 2025年Q1在中国三大终端六大市场，江西施美药业是高血压用药TOP50集团（一级），畅销产品包括了苯磺酸左氨氯地平片、替米沙坦氨氯地平片、培哚普利叔丁胺片、培哚普利吲达帕胺片。 2024年至今，江西施美药业在心脑血管系统药物市场还有16个新品报产在审，其中高血压用药11个、血脂调节剂5个。随着公司的新品及新药陆续上市，江西施美药业在心脑血管系统药物市场的地位将进一步提升，未来可期。资料来源：CDE官网、米内网数据库、公司公开资料等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月21日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准申请上市

2025-07-27

·信狐药迅

江苏万高1类化药注射用GD-11提交上市申请|新受理（7.21-7.27）

本周药品注册受理数据，分门别类呈现，一目了然。(7.21-7.27）新药上市申请药品名称企业注册分类受理号注射用GD-11江苏万高药业股份有限公司1CXHS2500085甲磺酸伏美替尼片上海艾力斯医药科技股份有限公司2.4CXHS2500084依沃西单抗注射液康方赛诺医药有限公司2.2CXSS2500077新药临床申请药品名称企业注册分类受理号WJB001胶囊微境生物医药科技(上海)有限公司1CXHL2500756注射用ARTS-876安锐生物医药科技(广州)有限公司1CXHL2500746埃诺格鲁肽片杭州先为达生物科技股份有限公司1CXHL2500745埃诺格鲁肽片杭州先为达生物科技股份有限公司1CXHL2500744埃诺格鲁肽片杭州先为达生物科技股份有限公司1CXHL2500743埃诺格鲁肽片杭州先为达生物科技股份有限公司1CXHL2500742特里豚蝎肽凝胶武汉摩尔生物科技有限公司1CXHL2500755TSL2109胶囊江苏天士力帝益药业有限公司1CXHL2500754TSL2109胶囊江苏天士力帝益药业有限公司1CXHL2500753LBS-007注射溶液北京希而欧生物医药开发有限公司1CXHL2500752HEP-50768片海湃泰克(北京)生物医药科技有限公司1CXHL2500751HEP-50768片海湃泰克(北京)生物医药科技有限公司1CXHL2500750HEP-50768片海湃泰克(北京)生物医药科技有限公司1CXHL2500749HEP-50768片海湃泰克(北京)生物医药科技有限公司1CXHL2500748BPR-6023021注射液成都欣科医药有限公司1CXHL2500747HTMC0435片上海壹典医药科技开发有限公司1CXHL2500739HTMC0435片上海壹典医药科技开发有限公司1CXHL2500738HTMC0435片上海壹典医药科技开发有限公司1CXHL2500737HTMC0435片上海壹典医药科技开发有限公司1CXHL2500736甲磺酸哆希替尼片河南真实生物科技有限公司1CXHL2500732甲磺酸哆希替尼片河南真实生物科技有限公司1CXHL2500731甲磺酸哆希替尼片河南真实生物科技有限公司1CXHL2500730KC1036片北京康辰药业股份有限公司1CXHL2500741KC1036片北京康辰药业股份有限公司1CXHL2500740EGFNASA胶囊宁波艾科索医药科技有限公司1CXHL2500729CMS-D002胶囊深圳市康哲生物科技有限公司1CXHL2500727CMS-D002胶囊深圳市康哲生物科技有限公司1CXHL2500728HL017辉粒药业(苏州)有限公司2.2CXHL2500735注射用紫杉醇阳离子脂质体石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500760盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2500759盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2500758盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2500757GEN-725片河南真实生物科技有限公司2.4CXHL2500734GEN-725片河南真实生物科技有限公司2.4CXHL2500733重组金黄色葡萄球菌四组分疫苗(大肠杆菌)江苏坤力生物制药有限责任公司1.1CXSL2500611三价流感病毒裂解疫苗(BK-01佐剂)长春百克生物科技股份公司3.2CXSL2500608注射用JS207上海君实生物医药科技股份有限公司1CXSL2500617注射用JS107上海君实生物医药科技股份有限公司1CXSL2500623注射用JS207上海君实生物医药科技股份有限公司1CXSL2500621注射用HLX43上海复宏瑞霖生物技术有限公司1CXSL2500619注射用HDM2017杭州中美华东制药有限公司1CXSL2500622重组抗EGFR人源化单抗注射液上海复宏瑞霖生物技术有限公司1CXSL2500620WSK-IM02北京威斯克生物医药有限公司1CXSL2500615SCTB14注射液神州细胞工程有限公司1CXSL2500613SCTB14注射液神州细胞工程有限公司1CXSL2500612脐血单个核细胞注射液广州熙帝生物科技有限公司1CXSL2500614RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2500610注射用RC118荣昌生物制药(烟台)股份有限公司1CXSL2500609贝莫苏拜单抗注射液正大天晴药业集团南京顺欣制药有限公司2.2CXSL2500624仿制药申请药品名称企业注册分类受理号注射用盐酸头孢替安/氯化钠注射液湖南科伦制药有限公司3CYHS2502693盐酸哌罗匹隆片浙江京新药业股份有限公司3CYHS2502697盐酸哌罗匹隆片浙江京新药业股份有限公司3CYHS2502696依巴斯汀口服溶液江苏万高药业股份有限公司3CYHS2502684吡格列酮二甲双胍片河南大新药业有限公司3CYHS2502679盐酸溴己新口服溶液合肥远志医药科技开发有限公司3CYHS2502677注射用乳糖酸红霉素海南允鼎医药科技有限公司3CYHS2502675盐酸多沙普仑注射液扬州中宝药业股份有限公司3CYHS2502669盐酸丙卡特罗干糖浆南京海纳制药有限公司3CYHS2502690维生素K1片上海宣泰医药科技股份有限公司3CYHS2502661复方电解质醋酸钠葡萄糖注射液武汉同济中维医药有限责任公司3CYHS2502660复方电解质醋酸钠葡萄糖注射液武汉同济中维医药有限责任公司3CYHS2502659坎地氢噻片宁波科尔康美诺华药业有限公司3CYHS2502656复方聚乙二醇(3350)电解质维C散四川科伦药业股份有限公司3CYHS2502655硝普钠注射液扬州中宝药业股份有限公司3CYHS2502646复方聚乙二醇3350电解质散泓友药业(海南)有限公司3CYHS2502666注射用盐酸多西环素广东金城金素制药有限公司3CYHS2502665注射用盐酸多西环素广东金城金素制药有限公司3CYHS2502663地诺孕素片上海汇伦医药股份有限公司3CYHS2502632多索茶碱片西洲医药科技(浙江)有限公司3CYHS2502629多索茶碱片西洲医药科技(浙江)有限公司3CYHS2502627布美他尼注射液江苏铭远药业有限公司3CYHS2502623辅酶Q10片漯河市汇创医药有限公司3CYHS2502621维生素B6注射液杭州民生药业股份有限公司3CYHS2502619布洛芬片珠海润都制药股份有限公司3CYHS2502645乙酰半胱氨酸注射液海南爱科制药有限公司4CYHS2502692氨甲环酸注射液河南普瑞药业有限公司4CYHS2502700氨甲环酸注射液河南普瑞药业有限公司4CYHS2502699氨甲环酸注射液河南普瑞药业有限公司4CYHS2502698利丙双卡因乳膏河北华晨药业集团有限公司4CYHS2502695利丙双卡因乳膏河北华晨药业集团有限公司4CYHS2502694瑞舒伐他汀依折麦布片(I)云鹏医药集团有限公司4CYHS2502691卡贝缩宫素注射液成都天台山制药股份有限公司4CYHS2502701西洛他唑片石家庄科仁医药科技有限公司4CYHS2502689苯磺酸左氨氯地平片河北宏鑫堂药业有限公司4CYHS2502688苯磺酸左氨氯地平片河北宏鑫堂药业有限公司4CYHS2502687呋喹替尼胶囊南京正大天晴制药有限公司4CYHS2502686呋喹替尼胶囊南京正大天晴制药有限公司4CYHS2502685蒙脱石混悬液浙江远力健药业有限责任公司4CYHS2502683戊酸雌二醇片湖南醇健制药科技有限公司4CYHS2502682盐酸特比萘芬喷雾剂浙江核力欣健药业有限公司4CYHS2502681盐酸莫西沙星滴眼液河北宏鑫堂药业有限公司4CYHS2502680过氧苯甲酰凝胶江苏盈科生物制药有限公司4CYHS2502678硫酸氨基葡萄糖胶囊河南中杰药业有限公司4CYHS2502676艾瑞昔布片仁合益康集团有限公司4CYHS2502674达格列净二甲双胍缓释片(I)河北智恒医药科技股份有限公司4CYHS2502673阿法骨化醇滴剂江西海尔思药业股份有限公司4CYHS2502672双氯芬酸二乙胺乳胶剂青岛百洋制药有限公司4CYHS2502670荧光素钠注射液珠海前列药业有限公司4CYHS2502671达格列净片天津力生制药股份有限公司4CYHS2502658达格列净片天津力生制药股份有限公司4CYHS2502657非奈利酮片中山万汉制药有限公司4CYHS2502654非奈利酮片中山万汉制药有限公司4CYHS2502653丙泊酚中/长链脂肪乳注射液辰欣药业股份有限公司4CYHS2502652丙泊酚中/长链脂肪乳注射液辰欣药业股份有限公司4CYHS2502651苯磺酸美洛加巴林片成都倍特药业股份有限公司4CYHS2502650苯磺酸美洛加巴林片成都倍特药业股份有限公司4CYHS2502649甲磺酸沙非胺片浙江兄弟药业有限公司4CYHS2502648甲磺酸沙非胺片浙江兄弟药业有限公司4CYHS2502647硫酸氨基葡萄糖胶囊江西迪赛诺医药集团有限公司4CYHS2502668艾普拉唑肠溶片浙江皓格药业有限公司4CYHS2502667盐酸达泊西汀片国源国药(广东)制药集团有限公司4CYHS2502664盐酸达泊西汀片国源国药(广东)制药集团有限公司4CYHS2502662蔗糖羟基氧化铁咀嚼片浙江昂利康制药股份有限公司4CYHS2502643吗啉硝唑氯化钠注射液海南丰恺思制药有限公司4CYHS2502642注射用阿莫西林钠克拉维酸钾/氯化钠注射液山东二叶制药有限公司4CYHS2502641注射用阿莫西林钠克拉维酸钾/氯化钠注射液山东二叶制药有限公司4CYHS2502640吸入用乙酰半胱氨酸溶液成都市海通药业有限公司4CYHS2502639小儿法罗培南钠颗粒博智安健(河北)药业有限公司4CYHS2502638玻璃酸钠滴眼液山东诺明康药物研究院有限公司4CYHS2502637瑞维那新吸入溶液海南美康达药业有限公司4CYHS2502636注射用氟氧头孢钠海南海灵化学制药有限公司4CYHS2502635聚乙烯醇滴眼液四川好医生攀西药业有限责任公司4CYHS2502634克立硼罗软膏武汉益博元医药科技有限公司4CYHS2502633盐酸达泊西汀片海南赛立克药业有限公司4CYHS2502631盐酸达泊西汀片海南赛立克药业有限公司4CYHS2502630磷酸芦可替尼片青岛国信制药有限公司4CYHS2502628磷酸芦可替尼片青岛国信制药有限公司4CYHS2502626磷酸芦可替尼片青岛国信制药有限公司4CYHS2502625酮洛芬凝胶湖南派格兰药业有限公司4CYHS2502624酮洛芬凝胶湖南派格兰药业有限公司4CYHS2502622美沙拉秦栓华东医药(西安)博华制药有限公司4CYHS2502620替米沙坦氨氯地平片吉林省德商药业股份有限公司4CYHS2502644盐酸奈必洛尔片浙江花园药业有限公司3CYHL2500131冻干b型流感嗜血杆菌结合疫苗北京百晖生物科技有限公司3.3CXSL2500616罗莫佐单抗注射液珠海联邦生物医药有限公司3.3CXSL2500618进口申请药品名称企业注册分类受理号BAY 2927088片Bayer HealthCare Pharmaceuticals Inc.1JXHS2500077麦考酚钠肠溶片Aurobindo Pharma Limited5.2JYHS2500029麦考酚钠肠溶片Aurobindo Pharma Limited5.2JYHS2500028Orforglipron片Eli Lilly and Company1JXHL2500199Orforglipron片Eli Lilly and Company1JXHL2500198Orforglipron片Eli Lilly and Company1JXHL2500197Orforglipron片Eli Lilly and Company1JXHL2500196Orforglipron片Eli Lilly and Company1JXHL2500195Orforglipron片Eli Lilly and Company1JXHL2500194PKN605片Novartis Pharma AG1JXHL2500191ASP5541注射液Astellas Pharma Global Development, Inc.2.1JXHL2500200LNP023胶囊Novartis Pharma AG2.4JXHL2500192维A酸过氧苯甲酰乳膏SOL-GEL TECHNOLOGIES LTD5.1JXHL2500193MK-7240注射液Merck Sharp & Dahme LLC1JXSL2500132PF-08046054 (注射用冻干粉针)Pfizer Inc.1JXSL2500125Depemokimab注射液GlaxoSmithKline Research & Development Limited1JXSL2500126BMS-986340注射液Bristol-Myers Squibb Company1JXSL2500124Risankizumab注射液AbbVie Inc.2.2JXSL2500131Risankizumab注射液AbbVie Inc.2.2JXSL2500130Risankizumab注射液AbbVie Inc.2.2JXSL2500129Risankizumab注射液AbbVie Inc.2.2JXSL2500128Risankizumab注射液AbbVie Inc.2.2JXSL2500127特泽利尤单抗注射液AstraZeneca AB2.2JXSL2500123中药相关申请药品名称企业注册分类受理号芍药甘草颗粒国药集团广东环球制药有限公司3.1CXZS2500031猴枣除痰散WAI YUEN TONG MEDICINE CO LTD.其他情形JYZS2500002欣力康胶囊贵阳新天药业股份有限公司2.3CXZL2500054注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

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

KEGG	Wiki	ATC	Drug Bank
-	-	C09DB04	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原发性高血压	欧盟	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	冰岛	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	列支敦士登	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	挪威	Boehringer Ingelheim International GmbH	2010-10-07
心脏衰竭	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
高血压	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
心肌梗塞	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
肾功能不全	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
脑卒中	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
视觉障碍	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16

未上市

10 条进展最快的记录,

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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	美国	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	比利时	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	加拿大	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	丹麦	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	芬兰	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	法国	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	荷兰	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	挪威	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	菲律宾	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	南非	Boehringer Ingelheim GmbH	2007-10-01

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临床结果

适应症

分期

评价

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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


NCT03067688 (Pubmed \| J Clin Hypertens (Greenwich))	临床3期	血脂障碍 \| 高血压	202	telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg	範積廠憲艱艱膚夢鏇網(廠淵憲獵廠網鬱衊艱顧) = 築簾簾獵膚艱獵夢醖艱獵窪醖膚製構壓蓋廠憲 (餘壓廠膚願簾醖顧齋餘 ) 更多	-	2020-10-01
				telmisartan 80 mg + rosuvastatin 20 mg	範積廠憲艱艱膚夢鏇網(廠淵憲獵廠網鬱衊艱顧) = 壓遞繭襯選繭構構構壓獵窪醖膚製構壓蓋廠憲 (餘壓廠膚願簾醖顧齋餘 )
NCT03566316 (Pubmed)	临床3期	高脂血症 \| 高血压	134	telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg	遞鏇糧製夢遞襯夢顧簾(鹽襯遞積齋鏇鹽窪鏇鹽) = 鹹觸顧獵襯遞繭鹽構餘鹽願糧鑰醖壓齋鏇艱築 (選製窪糧襯觸繭醖積鬱 ) 更多	-	2019-04-01
				telmisartan/amlodipine 80/10 mg	遞鏇糧製夢遞襯夢顧簾(鹽襯遞積齋鏇鹽窪鏇鹽) = 鏇築襯襯壓餘遞壓餘衊鹽願糧鑰醖壓齋鏇艱築 (選製窪糧襯觸繭醖積鬱 )
NCT02734355 (CTgov)	临床4期	心房颤动	64	Telmisartan 80 mg and amlodipine 5 mg (Therapy)	廠獵築鬱廠鬱醖鬱鏇艱(製選觸窪鬱窪醖構夢淵) = 鹽齋範鏇鬱糧觸淵鏇齋範夢糧鏇鏇艱窪願積鬱 (構顧衊積艱壓衊鏇鹹築, 4.4) 更多	-	2017-03-22
				Placebo (for telmisartan and amlodipine) (Placebo)	廠獵築鬱廠鬱醖鬱鏇艱(製選觸窪鬱窪醖構夢淵) = 艱襯鬱鹹繭築壓夢構齋範夢糧鏇鏇艱窪願積鬱 (構顧衊積艱壓衊鏇鹹築, 5.2) 更多
NCT01975246 (CTgov)	临床3期	高血压 \| 原发性高血压	309	Placebo+Telmisartan + amlodipine	窪選網簾鏇顧範艱糧範(壓網積夢壓鑰鹹膚衊獵) = 願醖製觸鬱醖壓襯製獵餘鬱餘衊膚襯壓衊壓鏇 (餘醖簾鹽醖鑰願鬱繭鏇, 0.5) 更多	-	2016-11-29
NCT01103960 (CTgov)	临床3期	高血压 \| 原发性高血压	324	Amlodipine (A5 Alone)	壓觸觸艱壓鏇遞窪願築(鹽夢構構獵衊夢憲網醖) = 簾廠鑰構觸選糧廠艱蓋網築衊網壓鏇遞鹹壓簾 (鑰糧構夢窪鹹繭鑰襯範, 0.93) 更多	-	2012-09-20
				Amlodipine+Telmisartan (T80/A5)	壓觸觸艱壓鏇遞窪願築(鹽夢構構獵衊夢憲網醖) = 鹽襯選壓築積壓衊積遞網築衊網壓鏇遞鹹壓簾 (鑰糧構夢窪鹹繭鑰襯範, 0.95) 更多
NCT01204398 (CTgov)	临床3期	高血压	27	Amlodipine+Telmisartan	夢顧憲鹹壓鹽選築鏇壓(膚蓋醖憲範齋獵觸觸鹹) = 憲顧遞蓋衊選製繭壓憲範鑰齋獵餘製顧鏇鑰願 (範夢獵鬱鏇顧築選簾選, 7.42) 更多	-	2012-08-24
NCT01134393 (CTgov)	临床3期	原发性高血压	502	Amlodipine+Telmisartan (T80/A5)	夢選鏇鹹淵蓋餘壓淵齋 = 蓋膚構淵廠繭觸選淵糧鹽淵構鏇網獵齋襯簾簾 (壓鑰鑰選艱觸廠壓顧夢, 鹽簾顧淵選艱繭築獵餘 ~ 顧網構網鏇鹽餘憲壓製) 更多	-	2012-07-04
				Amlodipine+Telmisartan (T80/A10)	膚觸淵鏇鹹積膚簾壓範(憲範積齋鏇窪齋構繭艱) = 淵淵鹹憲獵壓鏇衊簾遞觸範餘衊夢鹽淵遞膚鹽 (憲積簾夢觸簾製築鏇衊, 襯製構衊築鬱鹹齋鑰繭 ~ 願鏇廠廠廠醖鬱齋選鏇) 更多
NCT01222520 (CTgov)	临床3期	高血压 \| 原发性高血压	174	Telmisartan and amlodipine	簾窪壓繭鑰鑰淵醖鑰夢(願餘醖糧築艱膚鹹齋衊) = 鬱積鹹遞構構選壓廠鹹壓糧壓觸夢膚夢顧範繭 (鏇夢糧鑰壓窪鬱鹹糧觸, 0.73) 更多	-	2012-07-04
NCT00860262 (CTgov)	临床3期	高血压	858	Amlodipine+Telmisartan (T80+A10)	積廠鹽鹽衊壓獵糧網簾(壓廠鹽襯構鑰廠遞鹽餘) = 淵選鬱齋齋糧蓋願鏇糧齋構糧窪襯廠鬱餘鏇鏇 (築夢獵築衊鑰鬱築窪醖, 0.69) 更多	-	2011-01-04
				Telmisartan (Telmisartan 80 mg)	積廠鹽鹽衊壓獵糧網簾(壓廠鹽襯構鑰廠遞鹽餘) = 夢糧餘顧壓壓網觸齋築齋構糧窪襯廠鬱餘鏇鏇 (築夢獵築衊鑰鬱築窪醖, 0.96) 更多
TEAMSTA-10 (ESH2010)	N/A	高血压	838	Telmisartan 40 mg/Amlodipine 10 mg	構築選襯範構選觸製築(築願鏇糧簾衊壓憲憲築) = 1.9% (16/835) of patients discontinued trial treatment because of adverse events 廠鏇餘繭艱網餘醖鬱構 (衊艱蓋壓壓鑰範糧獵範 ) 更多	积极	2010-06-01
				Amlodipine 10 mg