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更新于：2025-03-21
Bilastine
比拉斯汀
更新于：2025-03-21
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)批准上市 |
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
121
项与 比拉斯汀 相关的临床试验TCTR20241223002
A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Bilastine 20 mg Tablets and Reference Product (Bilaxten) in Healthy Thai Subjects under Fasting Conditions
CTR20243535
评估受试制剂比拉斯汀片（规格：20mg）与参比制剂比拉斯汀片（规格：20mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究。
CTR20243538
比拉斯汀口腔崩解片（10 mg）在中国健康受试者中随机、开放、两制剂、两周期、双交叉空腹状态下生物等效性试验
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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336
项与 比拉斯汀 相关的文献（医药）2025-04-01ENVIRONMENTAL RESEARCH
Is the European regulatory model for predicting worker exposure conservative? Comparison of predicted and measured under usual working conditions exposures in fruit growing
Article
作者: Duporté, Geoffroy ; Bureau, Mathilde ; Lebailly, Pierre ; Budzinski, Hélène ; De Graaf, Lucie ; Baldi, Isabelle ; Bouchart, Valérie ; Bresson, Morgane
INTRODUCTION:
Pesticide exposure increases the risk of chronic disease among farmers. Understanding exposure is necessary for epidemiological and regulatory purposes. In Europe, worker exposure is assessed during the registration process using the OPEX model, which is based on a limited number of studies, often unpublished and carried out by pesticide companies. We assessed the conservativeness of OPEX for workers performing post-application tasks (re-entry, harvesting).
METHODS:
In 2016-2017, dermal exposure to captan/THPI and dithianon was measured in French fruit farm workers during 65 re-entry (net folding and deployment, thinning, tying) and 58 harvesting days, using patches and cotton gloves. We used linear regression to compare measured and corresponding OPEX-calculated exposure using 1) default parameters; 2) field parameters (actual task duration, measured dislodgeable foliar residues) for 20 observations.
RESULTS:
Workers were exposed several days after the last application, which is not considered in the pesticide registration process. We found that the model underestimated exposure calculated with field parameters in all observations for dithianon and 60% for captan, linked to an underestimation of OPEX transfer coefficients (ratio of 0.40 for captan and 0.26 for dithianon between default and measured transfer coefficients).
DISCUSSION:
When observation occurred several days after application, OPEX tended to underestimate exposure. An industry study conducted under controlled working conditions found divergent results. It seems important to include field studies conducted under usual working conditions in the registration process to ensure a truly conservative approach and to consider cumulative exposure, since post-application tasks account for around 600 working hours a year.
2025-02-01SCIENCE OF THE TOTAL ENVIRONMENT
Relationship between antihistamine residues in wastewater and airborne pollen concentrations: Insights into population-scale pollinosis response
Article
作者: Schmid-Grendelmeier, Peter ; Singer, Heinz ; Crouzy, Benoît ; Baumgartner, Stephan ; Ort, Christoph ; Salvisberg, Michelle ; Clot, Bernard
Pollinosis is the most prevalent allergic disorder. Assessing the impact of real-world pollen exposure on symptoms remains challenging due to extensive patient-level efforts required. This study explores the potential of wastewater-based epidemiology (WBE) to investigate the relationship between airborne pollen concentrations and antihistamine residues in wastewater as an indicator of pollinosis symptom treatment at the population-scale. In Zurich (Switzerland), 279 wastewater samples were collected during 2021-2023. Each sample represents a 24-h period with excreta from approximately 471,000 individuals. Eleven antihistamine markers were analyzed in the samples using liquid chromatography high-resolution mass spectrometry. The relationship between antihistamine loads in wastewater and airborne pollen concentrations (47 taxa and miscellaneous pollen) was investigated by determining seasonal components of antihistamine loads and exploring pollen-specific contributions using Non-Negative Least Squares (NNLS) optimization. Four antihistamines were detected in quantifiable amounts in wastewater. The first-generation antihistamine, diphenhydramine, demonstrated rather constant levels. In contrast, the three second-generation antihistamines - bilastine, cetirizine, and fexofenadine - showed pronounced day-to-day variation with strong correlations among each other. For fexofenadine, which was investigated in detail for its correlation with airborne pollen concentrations, approximately 50 % of the annual wastewater loads were associated with acute pollen exposure. Another 20 % related to baseline consumption during the pollen season, while the remaining 30 % seems unrelated to pollen. Birch, grasses, hazel, hornbeam, plane, and plantain explained most of the variance in wastewater loads (R2 = 0.82), with grass pollen alone accounting for a quarter of the annual loads. Increased fexofenadine loads during periods without elevated concentrations of common allergenic pollen suggests the presence of additional triggers for allergy symptoms, potentially yew pollen. Our study demonstrates that WBE can effectively reveal substantial day-to-day variation in antihistamine use related to pollen exposure. Thus, WBE presents an objective and questionnaire-independent method for investigating pollinosis symptom treatment at a population-scale.
2025-01-01JOURNAL OF VETERINARY MEDICAL SCIENCE
Comparing the effectiveness of four antihistamines with olopatadine in healthy Thoroughbred horses
Article
作者: MITA, Hiroshi ; IKEDA, Yasuhiko ; TAMURA, Norihisa ; OHTA, Minoru ; KURODA, Taisuke
We compared the antihistamine effect of four new antihistamines with olopatadine, which is used to treat equine allergic diseases. Six healthy Thoroughbred horses received oral doses of olopatadine (50 mg), levocetirizine (50 mg), bilastine (200 mg), rupatadine (100 mg), and desloratadine (50 mg) at >2-week intervals. The effects were investigated by measurement of the wheal area induced by histamine intradermal injection, and inhibition rate was compared with positive and negative controls. The maximum wheal inhibition rate (mean ± SD) of olopatadine (85.3% ± 7.7%) was significantly higher than those of bilastine (51.1% ± 11.8%), rupatadine (55.3% ± 6.6%), and desloratadine (59.8% ± 6.4%), but not levocetirizine (85.4% ± 8.0%). Levocetirizine is expected to have a high antihistamine effect on horses.
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 | 德国 | 2010-09-08 | |
| 荨麻疹 | 德国 | 2010-09-08 |
未上市
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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
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临床3期 | 228 | (Bilastine Ophthalmic Solution 0.6%) | 遞鹽鬱壓夢範醖醖壓鑰(網構糧範醖繭構選艱齋) = 製淵蓋簾觸築網範糧鹹 遞壓選鏇鑰窪淵網選鬱 (蓋鬱顧壓網構網鏇鹽醖, 0.9013) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 遞鹽鬱壓夢範醖醖壓鑰(網構糧範醖繭構選艱齋) = 夢顧壓鬱糧鹽積廠壓顧 遞壓選鏇鑰窪淵網選鬱 (蓋鬱顧壓網構網鏇鹽醖, 0.9504) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 壓願網網齋襯遞遞鬱窪(鹹製網網遞繭獵糧艱夢) = 顧餘醖蓋選範鏇膚憲鑰 膚淵艱觸糧憲齋膚顧觸 (製鬱願醖鏇選鏇窪廠願, 0.7809) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 壓願網網齋襯遞遞鬱窪(鹹製網網遞繭獵糧艱夢) = 窪範繭夢築艱觸餘積憲 膚淵艱觸糧憲齋膚顧觸 (製鬱願醖鏇選鏇窪廠願, 0.9449) 更多 | ||||||
临床1期 | 一线 | 12 | 窪製淵繭餘獵膚膚餘衊(餘艱齋襯鹹繭範淵觸襯) = 鹹鏇鏇廠壓糧壓觸網繭 獵壓繭築遞鑰鏇網夢範 (鏇簾糧鬱鑰壓網衊積齋 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 壓衊夢網壓窪壓選構構(製顧淵遞蓋遞廠鑰蓋網) = 夢窪淵構餘遞壓醖願艱 選鹽網壓繭膚製鹹蓋蓋 (膚襯製憲製範膚衊醖淵, 鑰築襯鹽鬱壓築糧糧窪 ~ 鏇獵衊顧鬱鬱構鬱簾餘) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 衊艱構繭糧膚醖範獵顧(糧鏇鬱鹹範醖顧製鹽餘) = 觸夢淵齋選鏇壓膚廠製 網糧夢糧襯膚壓網壓鏇 (廠襯獵願糧範鬱鹽簾鏇, 築艱淵積憲選遞壓窪網 ~ 膚齋壓製淵壓獵鑰顧鏇) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 鬱網獵齋鹹壓夢願衊願(淵鬱範夢願醖憲齋觸衊) = 糧窪獵選顧蓋蓋夢願簾 願顧膚顧窪鑰顧衊蓋艱 (積選構遞積簾製鹽鬱夢, 壓積遞選憲壓製獵繭襯 ~ 鏇願選淵鹹鬱顧襯襯網) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 窪願齋廠範顧醖蓋壓衊(遞鹹糧膚鏇醖顧繭願製) = 鹽顧淵獵衊鏇獵鬱衊襯 窪築鬱積鑰願襯醖鑰顧 (淵積夢壓積餘醖遞獵鬱, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | Bilastine at therapeutic dose (20 mg once daily) | 鬱顧繭壓醖夢壓範繭觸(鏇鏇膚簾選鏇簾鬱壓襯) = 簾夢齋範廠鏇繭鑰鑰繭 範鹹簾遞膚蓋醖艱膚選 (鬱夢襯窪願艱醖襯範鹹 ) | - | 2012-06-01 | |
Bilastine at supratherapeutic dose (100 mg once daily) | 鬱顧繭壓醖夢壓範繭觸(鏇鏇膚簾選鏇簾鬱壓襯) = 獵顧構窪艱餘積鬱願膚 範鹹簾遞膚蓋醖艱膚選 (鬱夢襯窪願艱醖襯範鹹 ) | ||||||
临床3期 | 683 | 願膚鏇繭餘積膚襯積糧(艱廠廠願願醖膚積醖夢) = 願構願衊襯鏇積淵夢積 衊齋鬱鑰糧觸蓋遞齋壓 (構鏇構壓衊範構鏇鏇獵 ) | 积极 | 2009-09-01 | |||
願膚鏇繭餘積膚襯積糧(艱廠廠願願醖膚積醖夢) = 淵積遞製餘網網構壓觸 衊齋鬱鑰糧觸蓋遞齋壓 (構鏇構壓衊範構鏇鏇獵 ) |
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