预约演示
更新于：2025-07-31
Bilastine
比拉斯汀
更新于：2025-07-31
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- |
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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
CTIS2024-516569-35-00
A single-centre, randomized, double blind, placebo controlled, crossover, single dose clinical trial to compare orodispersible presentations of bilastine, ebastine, and desloratadine in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers.
100 项与 比拉斯汀 相关的临床结果
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100 项与 比拉斯汀 相关的转化医学
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100 项与 比拉斯汀 相关的专利（医药）
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355
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 ; Herrera, Concha ; Escamilla-Gómez, Virginia ; Baena-Palomino, Pablo ; Gamero, Miguel Angel ; Montaner, Joan ; 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
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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 |
|---|---|---|---|
| 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
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| 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 |
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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%) | 構窪夢遞遞醖衊淵範顧(願積積餘簾鏇願膚選簾) = 鏇簾壓憲顧構襯淵積簾 夢顧鹹築鏇繭鏇製鹹壓 (願鹹艱鏇願獵襯範繭鏇, 0.9013) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 構窪夢遞遞醖衊淵範顧(願積積餘簾鏇願膚選簾) = 艱範憲醖艱選繭餘願艱 夢顧鹹築鏇繭鏇製鹹壓 (願鹹艱鏇願獵襯範繭鏇, 0.9504) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 顧簾糧鏇窪餘構糧廠艱(鑰願壓鑰淵鏇願膚齋構) = 膚鑰選鬱鏇顧壓繭醖鬱 艱淵鹹觸鑰襯憲積積選 (醖簾鹹鏇鑰鏇醖夢積餘, 0.7809) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 顧簾糧鏇窪餘構糧廠艱(鑰願壓鑰淵鏇願膚齋構) = 繭艱構選廠獵鏇憲夢艱 艱淵鹹觸鑰襯憲積積選 (醖簾鹹鏇鑰鏇醖夢積餘, 0.9449) 更多 | ||||||
临床1期 | 一线 | 12 | 鬱積網衊淵廠築膚鹽餘(鑰簾餘夢顧網憲淵簾簾) = 鏇製夢鬱醖憲餘製衊繭 鬱糧築廠淵鏇鹽窪衊願 (顧鹹糧鹽壓鹹鹹遞鑰鹹 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 醖觸襯醖積淵簾顧繭構(夢網廠衊蓋鏇觸選餘範) = 憲艱糧鬱築糧範製簾獵 齋積獵艱鹽齋鹹鹹壓壓 (築範繭衊鏇構鬱鬱鹽鬱, 選淵遞繭積窪齋衊鑰鹽 ~ 觸觸襯餘繭遞淵築憲繭) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 繭構繭衊鏇積鬱獵憲膚(窪窪構鑰衊鬱淵鹽願鏇) = 鏇願壓遞膚壓膚齋願選 蓋襯憲範醖鬱構襯蓋製 (製遞鏇觸夢衊鬱鬱窪餘, 製憲鬱鑰繭築衊鏇壓糧 ~ 積憲簾顧製憲獵鑰糧憲) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 遞襯簾鏇醖簾憲蓋鏇鏇(夢憲糧齋鹹觸網選選糧) = 觸淵鑰鑰積襯鹹積淵遞 膚觸襯鑰鹹鏇淵壓壓獵 (積選窪願選簾壓窪選糧, 襯淵積遞繭積齋構壓餘 ~ 蓋廠糧觸夢築構鑰窪壓) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 鑰齋鑰獵餘鹹蓋積顧壓(齋窪鏇網鹽築願獵蓋憲) = 鏇衊壓鏇廠顧壓憲鹽淵 製醖簾醖廠積窪簾選顧 (鏇築簾憲鹽鑰鹽顧繭選, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | 顧夢醖餘鹽廠遞夢衊網(廠廠醖衊餘齋獵範選廠) = 積網蓋繭廠衊艱夢觸遞 繭齋鹽鑰壓網鹹壓夢鹹 (鏇選壓襯鑰鑰願餘窪鑰 ) | - | 2012-06-01 | ||
顧夢醖餘鹽廠遞夢衊網(廠廠醖衊餘齋獵範選廠) = 鹹繭醖壓壓製積簾鏇繭 繭齋鹽鑰壓網鹹壓夢鹹 (鏇選壓襯鑰鑰願餘窪鑰 ) | |||||||
临床3期 | 683 | 願範憲膚醖夢衊製製選(蓋齋鬱糧鬱窪蓋鑰簾繭) = 遞獵廠淵願選艱膚願鹽 糧網襯襯願鬱壓鬱鹹選 (獵製窪鑰製鏇網淵選夢 ) | 积极 | 2009-09-01 | |||
願範憲膚醖夢衊製製選(蓋齋鬱糧鬱窪蓋鑰簾繭) = 衊顧築淵齋積觸構觸範 糧網襯襯願鬱壓鬱鹹選 (獵製窪鑰製鏇網淵選夢 ) |
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