预约演示
更新于：2025-08-12
Bilastine
比拉斯汀
更新于：2025-08-12
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)撤市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C28H37N3O3 |
InChIKeyACCMWZWAEFYUGZ-UHFFFAOYSA-N |
CAS号202189-78-4 |
关联
135
项与 比拉斯汀 相关的临床试验TCTR20250619004
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Bilastine 20 mg Tablets and Reference Product (BILAXTEN 20 mg tablets) in Healthy Thai Volunteers under Fasting Conditions
TCTR20250226007
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Bilastine 20 mg Tablets and Reference Product (Bilaxten) in Healthy Thai Volunteers under Fasting Conditions
CTR20252496
比拉斯汀口腔崩解片在健康参与者中空腹状态下的开放、随机、交叉生物等效性试验
100 项与 比拉斯汀 相关的临床结果
登录后查看更多信息
100 项与 比拉斯汀 相关的转化医学
登录后查看更多信息
100 项与 比拉斯汀 相关的专利（医药）
登录后查看更多信息
305
项与 比拉斯汀 相关的文献（医药）2025-09-01WATER RESEARCH
Biological ion exchange for natural organic matter removal from drinking water
Review
作者: Zimmermann, Karl ; Chen, William ; Barbeau, Benoit ; Schoutteten, Klaas ; Liu, Zhen ; Mohseni, Madjid ; Bérubé, Pierre
The state of knowledge for ion exchange (IEX) drinking water filters is updated in this review with new understandings that allow for dramatically extending filter run length from days to months or years between regenerations. By simply allowing IEX filters to operate past chloride exhaustion, water practitioners can take advantage of continuing natural organic matter removal through a combination of sulphate-based secondary IEX and bio-removal mechanisms. Herein, we review literature and add new findings to describe all three mechanisms and their relative contributions, and provide insights to design and operate biological IEX, or 'BIEX', drinking water filters. Generalizing with new and literature data on 34 case studies from three continents, the chloride-based primary IEX lasted 3,100 bed volumes (BV) with 69 % DOC removal, while sulphate-based secondary IEX provided an additional 24,400 BV of run length with 51 % DOC removal. Bio-removal provided 5-10 % DOC removal irrespective of the IEX mechanism, although bio-removal mechanisms are less understood. Treatment performance depended on operating conditions and influent water quality, specifically the ratio of [Total Anions]-to-[DOC] concentrations in influent water, for which a linear relationship was described as [%DOCremoval]=0.57-0.0123×[TotalAnions:DOCratio]. Two models are shared to estimate filter run length either from empirical data or by minimizing the operating expenses (OPEX). While OPEX was influenced by either brine disposal or resin replacement costs depending on the system's scale, the total costs were dominated by capital expenses. Meanwhile, resin lifetime was influenced by filter run length and regeneration, and so cleaning approaches are discussed including caustic or citric acid. Understanding the mechanisms for DOC removal and informed with empirical models to predict treatment performance and run length, our renewed knowledge of ion exchange drinking water filters enables water practitioners to capitalize on their low-maintenance and long-term treatment abilities as a tool for safe drinking water in small and large water systems worldwide.
2025-08-01STROKE
Diffusion Tensor Imaging Study After Intraarterial Cell Therapy in Acute Ischemic Stroke: A Substudy of the IBIS Randomized Clinical Trial
Article
作者: Puig, Josep ; Escamilla-Gómez, Virginia ; Baena-Palomino, Pablo ; Herrera, Concha ; Montaner, Joan ; Gamero, Miguel Angel ; Martí-Navas, Marian ; Aguilar-Pérez, Marta ; Medina-Rodríguez, Manuel ; Valverde, Roberto ; González, Alejandro ; Pardo-Galiana, Blanca ; Villagran, Diego ; Jiménez, Rosario ; Aguera-Morales, Eduardo ; Moniche, Francisco ; Ortega-Quintanilla, Joaquín ; Cabezas-Rodríguez, Juan Antonio ; Zapata-Arriaza, Elena ; Pineda, Víctor ; Nogueras, Sonia ; Biarnes, Carles ; de Albóniga-Chindurza, Asier ; Gutiérrez, Isabel ; Calderón-Cabrera, Cristina ; Piñero, Pilar ; Hermosín, Andrés ; Ocete-Pérez, Rafael ; Martín, Vanesa ; Delgado, Fernando ; Comas-Cufí, Marc ; Ainz-Gomez, Leire
BACKGROUND::
Bone marrow mononuclear cell (BM-MNC) intraarterial transplantation has emerged as a potential stroke therapy. We aimed to determine whether BM-MNC therapy induces changes in diffusion tensor imaging metrics of major white matter tracts.
METHODS::
The IBIS trial was an investigator-initiated multicenter, phase IIb, randomized, controlled, assessor-blinded, clinical trial. Seventy-seven patients (aged 18–80 years) with a nonlacunar middle cerebral artery ischemic stroke within 1 to 7 days from stroke onset and a National Institutes of Health Stroke Scale score of 6 to 20 were included. The primary outcome was the modified Rankin Scale score at 6 months. Among these participants, 38 patients (20 BM-MNCs-treated and 18 controls) had diffusion tensor imaging data available at both baseline and 6-month follow-up. Fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity for white matter tracts were obtained. We determined the average changes in diffusion tensor imaging-metric values over the follow-up period and correlated corticospinal tract integrity with clinical outcomes using Spearman´s correlation coefficient.
RESULTS::
The mean (SD) age was 60.7 (14.01) years; 22 (57.9%) were men, and 31 (81.6%) underwent thrombectomy. The median (interquartile range) National Institutes of Health Stroke Scale score before randomization was 12 (9–15). Baseline diffusion tensor imaging metrics were comparable between groups. Fractional anisotropy values of patients treated with BM-MNC decreased significantly less throughout corticospinal tract ipsilateral to stroke lesion (−0.05 [95% CI, −0.07 to −0.03] versus −0.06 [95% CI, −0.09 to −0.04];
P
<0.0001) and the body of corpus callosum (−0.03 [95% CI, −0.01 to −0.07] versus −0.04 [95% CI, −0.02 to 0.08];
P
<0.0001]. Better preservation of the ipsilateral corticospinal tract measured with fractional anisotropy was significantly correlated with clinical outcomes (ie, modified Rankin Scale score [
r
=−0.478], National Institutes of Health Stroke Scale score [
r
=−0.594], Barthel index [
r
=0.466] at 6 months [all
P
<0.01]).
CONCLUSIONS::
Intraarterial autologous BM-MNC transplantation within 7 days after stroke onset seems to modify long-term white matter tract microstructure, suggesting that this cell therapy may mitigate acute stroke damage, through main projection fibers. Greater corticospinal tract preservation was associated with improved clinical outcomes.
REGISTRATION::
https://www.clinicaltrials.gov
; Unique identifier: NCT02178657.
2025-07-01EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS
Bioequivalence and Safety of Bilastine 20 mg Administered in Three Eight-Hourly Dose Versus a Single Daily Dose: A Randomized Two-Treatment, Two-Period, Cross-Over Comparative Study
Article
作者: Patil, Saiprasad ; Kodgule, Rahul ; Sinha, Ekta ; Barkate, Hanmant ; Bhagat, Sagar ; Modi, Vinayak
BACKGROUND AND OBJECTIVE:
Antihistamines are an essential treatment option for cough and upper respiratory symptoms. Bilastine is a 2nd-generation antihistamine which is approved as a 20 mg once daily dose. The objective of the current study is to compare the oral bioavailability of bilastine administered thrice daily as a triple combination syrup of test product bilastine + dextromethorphan hydrobromide + phenylephrine hydrochloride (3.3 mg + 10 mg + 5 mg)/5 mL and a reference product of single-dose administration of 2.5 mg/mL (bilastine 2.5 mg) in healthy, adult, male human subjects under fed condition.
METHODS:
This was an open-label, balanced, randomized, two-treatment, two-period, cross-over comparative bioavailability study. Patients were administered 10 mL of three 8-hourly doses of the triple combination test product and once daily dose of the reference product (syrup containing bilastine 2.5 mg). A 7-day washout period was implemented between doses. Blood samples were collected to assess the oral bioavailability of the test and reference products. Each subject received both treatments, serving as their own control, eliminating the need for a separate control group. Blood samples were collected pre-dose and at various intervals post-dose to determine plasma concentrations of bilastine using LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry. Primary pharmacokinetic parameters were analyzed for bioequivalence using SAS version 9.4.
RESULTS:
A total of 34 subjects out of 36 enrolled, successfully completed the study, and were analyzed. The geometric mean ratios of test versus reference product for the areas under the curve (AUC0-t and AUC0-∞ ) were 88.42% (84.15-92.91%) and 98.06% (93.63-102.69%), respectively, which are within the bioequivalence acceptance limits of 80.00-125.00%.
CONCLUSION:
Our study concluded that the test product, bilastine + dextromethorphan hydrobromide + phenylephrine hydrochloride syrup (3.3 mg + 10 mg + 5 mg)/5 mL, and the reference product, bilastine solution 2.5 mg/mL, are bioequivalent with respect to the extent of absorption and were well tolerated.
100 项与 比拉斯汀 相关的药物交易
登录后查看更多信息
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 |
|---|---|---|---|
| 慢性荨麻疹 | 加拿大 | 2016-12-02 | |
| 皮炎 | 日本 | 2016-09-28 | |
| 湿疹 | 日本 | 2016-09-28 | |
| 瘙痒 | 日本 | 2016-09-28 | |
| 瘙痒 | 日本 | 2016-09-28 | |
| 过敏性鼻炎 | 日本 | 2016-09-28 | |
| 过敏性鼻炎 | 日本 | 2016-09-28 | |
| 季节性过敏性鼻炎 | 加拿大 | 2016-04-21 | |
| 过敏性鼻结膜炎 | 奥地利 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 比利时 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 保加利亚 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 塞浦路斯 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 捷克 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 丹麦 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 爱沙尼亚 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 芬兰 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 法国 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 德国 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 希腊 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 匈牙利 | 2010-09-08 |
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 |
|---|---|---|---|---|
| 变应性结膜炎 | 临床3期 | 美国 | 2018-04-07 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2004-05-01 | |
| 季节性过敏性结膜炎 | 临床2期 | 美国 | 2007-12-01 | |
| 鼻结膜炎 | 临床2期 | 加拿大 | 2007-10-01 |
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3期 | 228 | (Bilastine Ophthalmic Solution 0.6%) | 獵壓鬱鑰夢廠繭壓襯蓋(繭網襯夢窪簾憲蓋鏇構) = 憲網鑰觸衊選選淵醖糧 顧艱鏇顧憲膚鏇醖鹽衊 (齋醖鏇構選艱憲顧構蓋, 0.9013) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 獵壓鬱鑰夢廠繭壓襯蓋(繭網襯夢窪簾憲蓋鏇構) = 蓋憲襯積網觸鬱蓋製淵 顧艱鏇顧憲膚鏇醖鹽衊 (齋醖鏇構選艱憲顧構蓋, 0.9504) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 繭鹽觸選艱鏇構網鹹糧(蓋願夢網築構艱簾膚願) = 蓋鹹構衊願築鹽選製範 築壓簾範願構簾積鑰夢 (繭遞鏇淵蓋憲遞憲獵鏇, 0.7809) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 繭鹽觸選艱鏇構網鹹糧(蓋願夢網築構艱簾膚願) = 艱襯觸積鹽鏇衊鬱獵範 築壓簾範願構簾積鑰夢 (繭遞鏇淵蓋憲遞憲獵鏇, 0.9449) 更多 | ||||||
临床1期 | 一线 | 12 | 觸淵夢艱網築夢顧範製(餘繭蓋廠衊鹹襯構積壓) = 膚鏇鏇窪鹹積鬱築鬱構 蓋鹹鏇醖範構繭餘窪獵 (獵選艱鏇艱構繭製鬱製 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 廠選顧積範積觸衊憲繭(襯構衊簾淵壓網餘憲積) = 夢顧鏇鏇顧蓋淵淵廠窪 衊蓋齋夢積簾醖憲鑰網 (網網範網蓋齋鏇製願鑰, 窪壓衊窪鏇艱鹹製壓憲 ~ 襯製築窪鏇膚淵醖獵窪) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 簾糧鑰壓鏇廠淵齋網遞(壓憲繭餘壓觸壓餘願襯) = 憲獵顧築鹹築鬱繭鏇壓 廠觸觸壓鑰窪鹽簾餘膚 (遞製範鑰遞膚衊願願醖, 鏇鏇積餘選窪願願鹽糧 ~ 夢夢壓範醖鬱糧蓋衊鑰) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 構淵願遞鹹襯鏇網製鏇(夢衊願顧積糧鑰蓋憲簾) = 膚夢淵選鏇網遞糧鹽淵 淵襯醖鑰觸憲構願願範 (觸壓網鬱餘糧廠網選蓋, 願餘壓構構鏇醖夢鏇鬱 ~ 構窪廠簾鏇廠繭觸廠餘) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 衊繭糧膚築築鏇觸鏇獵(製積遞鑰艱範廠繭夢壓) = 構築積窪艱遞齋願製憲 鹽鏇築憲鑰鑰膚構構壓 (願製範構願鑰艱蓋壓範, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | 繭鏇遞鑰築壓鹹餘齋網(繭鏇齋鏇夢鏇窪選製蓋) = 蓋夢網蓋艱蓋憲顧繭齋 鑰願鏇艱餘鹹鬱繭獵構 (繭淵蓋壓鹹鹽製繭鑰憲 ) | - | 2012-06-01 | ||
繭鏇遞鑰築壓鹹餘齋網(繭鏇齋鏇夢鏇窪選製蓋) = 蓋淵鹽壓衊鬱糧獵襯遞 鑰願鏇艱餘鹹鬱繭獵構 (繭淵蓋壓鹹鹽製繭鑰憲 ) | |||||||
临床3期 | 683 | 積襯膚簾醖醖齋鹹夢獵(壓範範鹹簾壓壓顧繭壓) = 廠網蓋壓獵顧遞顧壓壓 積壓積鑰鹽遞製繭網鹹 (衊鹽夢網鏇繭艱鏇顧糧 ) | 积极 | 2009-09-01 | |||
積襯膚簾醖醖齋鹹夢獵(壓範範鹹簾壓壓顧繭壓) = 製艱艱獵齋鹹艱築鹽鹹 積壓積鑰鹽遞製繭網鹹 (衊鹽夢網鏇繭艱鏇顧糧 ) |
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
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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