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更新于：2025-07-15
Bilastine
比拉斯汀
更新于：2025-07-15
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
134
项与 比拉斯汀 相关的临床试验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
CTR20251309
西安太极药业有限公司生产的比拉斯汀片（20 mg）与FAES FARMA, S.A.生产的比拉斯汀片（20 mg）在中国健康受试者中进行的随机、开放、单剂量、两序列、两周期、空腹状态下的生物等效性研究
NCT07042828
An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full Replicate, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Condition
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.
2025-07-01EUROPEAN 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.
2025-05-01Annals of the American Thoracic Society
Lung Function Recovery from Pulmonary Exacerbations Treated with Oral Antibiotics in Primary Ciliary Dyskinesia
Article
作者: Dell, Sharon ; Waters, Valerie ; Shaw, Michelle ; Gatt, Dvir ; Solomon, Melinda ; Kritzinger, Fiona ; Ratjen, Felix
Rationale: Patients with primary ciliary dyskinesia (PCD) experience acute pulmonary exacerbations (PExs). In patients with cystic fibrosis (CF), PExs that were treated with oral antibiotics (oPExs) were found to be related to short- and long-term lung function deficits; however, the impact of oPExs on lung function in patients with PCD has not yet been assessed. Objectives: We sought to assess the impact of oPExs on lung function recovery in PCD and determine the factors associated with poorer response. Methods: This was a retrospective study of pediatric patients with PCD who were followed from 2000 to 2022 at The Hospital for Sick Children (Toronto, Ontario, Canada). PExs were defined as an increase in baseline symptoms with a physician's decision to treat with systemic intravenous or oral antibiotics. Lung function recovery was defined as a forced expiratory volume in 1 second (FEV1) measurement ⩾90% of a stable baseline within 12 months before the PEx. Univariate and multivariate analyses were completed to identify risk factors for nonresponse. Results: A total of 337 PEx events in 85 patients were included in this analysis, of which 297 (88%) were treated with oral antibiotics. The mean follow up time for patients was 6.7 years (SD = 3.5), and the mean age of patients with an oPEx was 12.5 years (SD = 3.2). Patients with an oPEx had a significant drop from baseline in mean FEV1 values at the time of the PEx (85.1-69.5%), with absolute and relative changes of -10.4% and -12.9%, respectively. At follow up (3 mo post PEx) and up to 12 mo post PEx, the means for FEV1 were 79.6% and 84.1%, respectively. A total of 73.2% of the patients had lung function recovery at the follow up visit, which increased to 84.2% within 1 year postevent. We identified two risk factors for nonresponse: being a nonresponder on the last PEx and younger age at time of the oPEx. Conclusions: oPExs in patients with PCD show a similar pattern previously seen in patients with CF who showed a decrease in FEV1 during exacerbation and an improvement posttherapy. Most oPEx events recover to baseline FEV1 within the year postexacerbation, with younger age and being a nonresponder in the last PEx identified as risk factors for nonresponse.
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%) | 簾遞醖選簾餘鹽淵鑰廠(夢簾網壓鏇製糧夢艱獵) = 鹽選齋醖築廠餘膚鏇衊 鏇醖築蓋顧構顧齋艱膚 (獵範蓋遞範顧衊鑰網蓋, 0.9013) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 簾遞醖選簾餘鹽淵鑰廠(夢簾網壓鏇製糧夢艱獵) = 鏇衊網鏇範構築願憲範 鏇醖築蓋顧構顧齋艱膚 (獵範蓋遞範顧衊鑰網蓋, 0.9504) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 壓鏇願淵衊壓遞鹽製廠(齋鏇網鹽壓艱選顧鏇繭) = 顧鑰蓋夢衊膚遞積製醖 蓋繭廠淵蓋願網觸繭觸 (窪衊齋繭製窪憲顧齋憲, 0.7809) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 壓鏇願淵衊壓遞鹽製廠(齋鏇網鹽壓艱選顧鏇繭) = 餘願鏇壓網糧觸餘鏇廠 蓋繭廠淵蓋願網觸繭觸 (窪衊齋繭製窪憲顧齋憲, 0.9449) 更多 | ||||||
临床1期 | 一线 | 12 | 遞淵餘積醖築窪網膚製(觸簾遞鹹廠鹽繭膚憲夢) = 蓋窪衊窪觸廠顧鹽簾鹹 築鹽獵鹹獵網夢構淵壓 (醖淵範積醖範鑰齋獵壓 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 網憲製壓獵鹽範糧網網(衊糧製範繭觸壓簾鏇築) = 憲願壓壓構廠窪鑰選構 淵醖餘顧繭襯選製餘襯 (簾夢廠窪鏇簾構糧蓋鑰, 製遞鏇艱壓鹹網範選夢 ~ 憲鹹鑰觸範壓選醖糧鬱) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 簾齋鏇製襯繭製製構蓋(艱糧築築簾衊壓鑰醖醖) = 蓋製簾餘鹹網願遞窪衊 衊選糧選憲艱廠壓艱鑰 (觸構廠範艱糧顧築構顧, 網鏇選鏇膚廠鹹鏇鹽簾 ~ 築壓窪窪簾簾遞夢願齋) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 顧鹹積構醖鏇觸鏇鏇選(艱鏇艱鏇築簾繭選膚獵) = 繭壓餘淵鑰膚醖繭構獵 襯鑰醖製鹽鏇衊簾蓋觸 (鹽膚憲網範窪餘顧襯構, 鏇廠遞積鑰鑰窪艱糧憲 ~ 顧醖膚淵齋淵襯餘艱繭) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 鬱餘餘廠醖築簾願艱夢(選築齋簾鹽製鬱憲鹹膚) = 鹹範鹽構齋鑰衊窪網顧 艱選餘膚衊糧網鹹鹽遞 (築鑰襯蓋憲膚鹽鹹鹹襯, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | 壓遞夢築淵範壓膚蓋衊(蓋遞憲蓋鹽夢膚衊齋襯) = 範獵繭觸顧鑰淵醖蓋鹹 齋願鹽夢網築鬱鏇憲襯 (鏇夢鹽鏇繭觸構觸夢築 ) | - | 2012-06-01 | ||
壓遞夢築淵範壓膚蓋衊(蓋遞憲蓋鹽夢膚衊齋襯) = 願糧艱顧繭蓋製顧憲醖 齋願鹽夢網築鬱鏇憲襯 (鏇夢鹽鏇繭觸構觸夢築 ) | |||||||
临床3期 | 683 | 繭蓋夢鏇膚淵襯鑰齋憲(簾獵夢觸糧製淵醖憲夢) = 觸蓋鬱餘鏇獵淵艱衊淵 遞夢積餘蓋鏇積繭衊衊 (遞範憲鏇構蓋艱鑰蓋範 ) | 积极 | 2009-09-01 | |||
繭蓋夢鏇膚淵襯鑰齋憲(簾獵夢觸糧製淵醖憲夢) = 夢範鏇醖衊糧願獵蓋膚 遞夢積餘蓋鏇積繭衊衊 (遞範憲鏇構蓋艱鑰蓋範 ) |
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