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更新于：2025-02-12
Rebamipide
雷巴米特
更新于：2025-02-12
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (1990-09-28), |
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C19H15ClN2O4 |
InChIKeyALLWOAVDORUJLA-UHFFFAOYSA-N |
CAS号90098-04-7 |
关联
144
项与 雷巴米特 相关的临床试验CTR20243901
健康受试者空腹和餐后状态下单次口服瑞巴派特片的随机、开放、两序列、两制剂、两周期、双交叉设计的生物等效性试验
CTR20242604
瑞巴派特片采用单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计，分为空腹给药和餐后给药的人体生物等效性研究。
CTR20240809
健康受试者单次口服瑞巴派特片的随机、开放、两周期、两序列、双交叉，空腹和高脂餐后给药条件下的人体生物等效性试验。
100 项与 雷巴米特 相关的临床结果
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100 项与 雷巴米特 相关的转化医学
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100 项与 雷巴米特 相关的专利（医药）
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1,034
项与 雷巴米特 相关的文献（医药）2025-01-01Early Intervention in Psychiatry
Psychometric properties of the Spanish version of the measure of insight into cognition‐self‐report in psychosis‐risk and non‐clinical Mexican young adults
Article
作者: Robles, Rebeca ; Sheinbaum, Tamara ; Medalia, Alice ; Domínguez, Tecelli ; Flores, Yvonne ; Fresán, Ana ; Nieto, Lourdes
Abstract:
Aim:
Cognitive disturbances typically precede the onset of overt psychotic symptoms and represent a neurobiological marker for psychosis risk that is also associated with poor functional outcomes. The Measure of Insight into Cognition‐Self Report (MIC‐SR) is a widely used 12‐item questionnaire that assesses the perceived frequency of cognitive impairment in the domains of executing functioning, attention, and memory. However, the MIC‐SR is not available in Spanish, one of the most widely spoken languages worldwide. The present study aimed to provide a Spanish version of the MIC‐SR and examine its psychometric properties in psychosis‐risk and non‐clinical Mexican young adults.
Methods:
The sample comprised 621 participants who completed a battery of self‐report measures via an online survey. Of the participants, 478 were non‐clinical, and 143 met the screening criteria for a clinical high‐risk for psychosis (CHR‐positive).
Results:
Confirmatory Factor Analyses supported a one‐factor model, consistent with the findings for the original MIC‐SR. The results showed adequate fit indices for the general model and the independent models for both groups, with high Cronbach's alpha coefficients. Furthermore, the CHR‐positive group showed more frequent subjective cognitive problems on each of the 12 items, higher total scores, and higher average frequency than the non‐clinical group.
Conclusion:
To our knowledge, this is the first translation of the MIC‐SR into Spanish. Using the MIC‐SR at the CHR stage may contribute to our understanding of cognitive processes associated with the onset of a psychotic disorder and provide valuable information in the context of detection and early intervention efforts.
2025-01-01EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Preparation and characterization of the ground mixture of rebamipide commercial tablets and Hydroxypropyl Cellulose-SSL by ball-milling: Application to the dispersoid of mouthwash suspension
Article
作者: Kawano, Yayoi ; Hanawa, Takehisa ; Ishii, Naoko ; Hirose, Kaoru ; Mizobuchi, Senri
In the present study, to prepare dispersoids with high dispersion stability that can be used as mouthwash, ground mixtures of commercial rebamipide (RB) tablets and hydroxypropyl cellulose (HPC-SSL) samples were prepared by dry milling. The physicochemical properties of the ground mixture of HPC-SSL and the powder obtained from the preliminary ground RB tablets were then compared. The dispersoids' physicochemical properties, dispersion stability, retention, and diffusiveness to the mucosal surfaces were evaluated in vitro. By co-grinding with HPC-SSL, RB transformed into fine particles around 303.6 - 361.5 nm that tended to prevent particle agglomeration in solution over time. The sample microparticles formed with HPC-SSL also avoided agglomeration on the mucosal surface for 24 h, improving oral retention. Furthermore, the ground mixture of HPC-SSL and the powder obtained from the preliminary ground RB tablets dispersed and permeated the mucus gel layer on the mucosal surface (24.2 %) but not the mucosal cells, indicating that RB remained on the mucosal surface. These results suggest that ground mixtures of commercial rebamipide (RB) tablets and hydroxypropyl cellulose (HPC-SSL) samples can be applied as a powdered suspension preparation because they showed high dispersion stability and oral mucosal retention.
2024-12-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Validated UPLC-MS/MS method for quantification of melatonin receptor agonists and dual orexin receptor antagonists in human plasma and breast milk: Application to quantify suvorexant and lemborexant in clinical samples
Article
作者: Furugen, Ayako ; Okamoto, Keisuke ; Aoyagi, Ryoichi ; Ishikawa, Shuhei ; Ishikawa, Hina ; Kobayashi, Masaki ; Sugawara, Mitsuru ; Umazume, Takeshi ; Nishimura, Ayako ; Takekuma, Yoh ; Narumi, Katsuya
Pharmaceutical care is important for mental health during the perinatal period, which is often characterized by insomnia. In recent years, prescriptions of melatonin receptor agonists (MRAs) and dual orexin receptor antagonists (DORAs) for insomnia have increased; however, their use during the perinatal period has scarcely been reported. In the present study, we developed a UPLC-MS/MS method for the quantification of ramelteon, its metabolite M-II, suvorexant, and lemborexant in human plasma and breast milk to accumulate information on the safety and transfer of MRAs and DORAs into breast milk. Samples of MRAs (ramelteon and M-II) in plasma and breast milk were prepared using liquid-liquid extraction (LLE) with ethyl acetate. For DORAs (suvorexant and lemborexant), LLE with ethyl acetate was applied to plasma samples. For breast milk samples, significant ion suppression was observed for LLE with ethyl acetate. Solid-phase extraction (SPE) cartridges capable of removing phospholipids improved the matrix effects. Finally, protein precipitation with methanol and an SPE cartridge, InertSep® Phospholipid Remover, were selected for breast milk sample preparation. An ACQUITY UPLC BEH C18 column was used for analyte separation. MRAs and DORAs were eluted using isocratic and gradient elution, respectively, and analyzed using electrospray ionization in the positive mode with multiple reaction monitoring. The range of calibration curve for MRAs and DORAs was 0.1-25 and 0.5-50 ng/ml, respectively. Both the plasma and breast milk samples exhibited good linearity over this range. The method was validated by evaluating its accuracy and precision, matrix effect, recovery, carry-over, stability, and dilution integrity. The validated method was successfully applied to clinical samples donated by breastfeeding women and the milk/plasma (M/P) ratio and relative infant dose (RID) of lemborexant (one case) and suvorexant (two cases) were estimated. The M/P ratio of lemborexant was <1, and the RID was 1.05 %. The M/P ratio of suvorexant was <0.1, and RID was 0.11-0.20 %. This method will be useful for future studies evaluating the safety of these drugs during breastfeeding.
100 项与 雷巴米特 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 |
|---|---|---|---|
| 胃炎 | 日本 | 1994-06-01 | |
| 胃溃疡 | 日本 | 1990-09-28 |
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 |
|---|---|---|---|---|
| 干眼综合征 | 申请上市 | 韩国 | - | |
| 急性胃炎 | 临床3期 | 韩国 | 2019-12-30 | |
| 强直性脊柱炎 | 临床3期 | 韩国 | 2007-12-01 | |
| 骨关节炎 | 临床3期 | 韩国 | 2007-12-01 | |
| 类风湿关节炎 | 临床3期 | 韩国 | 2007-12-01 | |
| 毒性 | 临床3期 | 韩国 | 2007-12-01 | |
| 慢性胃炎 | 临床3期 | 印尼 | 2007-10-01 | |
| 消化不良 | 临床3期 | 印尼 | 2007-10-01 | |
| 干燥综合征性角膜结膜炎 | 临床3期 | 美国 | 2004-05-01 | |
| 头颈部肿瘤 | 临床2期 | 日本 | 2014-03-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 新冠肺炎后遗症 CRP | 62 | 構獵糧夢鹹範壓襯觸積(淵淵壓餘艱顧糧選積顧) = 鏇鏇衊蓋壓齋觸廠醖憲 夢廠鹽夢壓鏇廠鹽築鬱 (繭鏇獵顧衊築製顧窪選, [1.85 ~ 2.62]) | 积极 | 2024-02-23 | ||
構獵糧夢鹹範壓襯觸積(淵淵壓餘艱顧糧選積顧) = 窪顧範鹽獵繭鏇衊網鏇 夢廠鹽夢壓鏇廠鹽築鬱 (繭鏇獵顧衊築製顧窪選, [2.68 ~ 3.9]) | |||||||
临床2期 | 124 | (Rebamipide 60 mg) | 顧廠遞襯夢膚醖壓憲鹽(遞獵觸範簾鏇繭範顧觸) = 遞繭簾網網鑰醖範夢遞 蓋窪壓鑰襯築餘鹽壓廠 (願願鏇壓鹹願積鹽簾鬱, 鬱夢製範繭築窪遞蓋製 ~ 憲蓋襯簾夢蓋積廠窪願) 更多 | - | 2021-07-20 | ||
(Rebamipide 150 mg) | 顧廠遞襯夢膚醖壓憲鹽(遞獵觸範簾鏇繭範顧觸) = 衊選鏇製餘餘範構鏇鏇 蓋窪壓鑰襯築餘鹽壓廠 (願願鏇壓鹹願積鹽簾鬱, 夢製積衊膚觸獵鏇願範 ~ 鏇鹹構壓膚遞壓顧窪壓) 更多 | ||||||
临床1期 | 100 | (OPC-12759 Solution With Nasal Root Pressed/Not Pressed) | 網築積醖遞願齋膚網鑰(顧齋繭艱淵鑰衊遞鹹鹹) = 鑰艱衊壓鹽廠鏇壓鏇網 繭鏇選糧鹽餘網艱鏇構 (範夢糧繭獵簾鏇糧蓋遞, 網艱鏇鏇觸蓋憲鏇繭蓋 ~ 簾選餘壓糧積餘壓簾鬱) 更多 | - | 2021-06-29 | ||
(OPC-12759 Suspension With Nasal Root Pressed/Not Pressed) | 網築積醖遞願齋膚網鑰(顧齋繭艱淵鑰衊遞鹹鹹) = 觸衊選範製獵獵鹽顧衊 繭鏇選糧鹽餘網艱鏇構 (範夢糧繭獵簾鏇糧蓋遞, 製憲顧獵夢廠獵構鬱膚 ~ 鬱鏇醖網獵壓淵壓築鏇) 更多 | ||||||
临床3期 | 209 | Placebo | 餘鏇齋獵範襯顧衊齋餘(製夢糧顧窪窪醖顧蓋衊) = 襯淵築壓壓選鹹積鹹製 範鑰鹹繭願鑰衊顧蓋觸 (齋鬱築築鹹網觸齋構膚, 觸製窪簾選艱鏇築築製 ~ 構觸蓋鹽憲艱繭鏇憲製) 更多 | - | 2021-05-05 | ||
临床2期 | 94 | (2% Rebamipide Liquid) | 齋衊醖廠憲艱積窪觸淵(顧築鏇襯鏇壓積觸襯鏇) = 遞網醖繭衊廠壓願觸壓 鑰艱選壓積觸襯製繭餘 (鏇蓋築壓鏇鏇淵簾積觸, 壓鏇艱網網夢夢觸積製 ~ 顧鹽顧鑰簾積製繭衊獵) 更多 | - | 2021-04-06 | ||
(4% Rebamipide Liquid) | 齋衊醖廠憲艱積窪觸淵(顧築鏇襯鏇壓積觸襯鏇) = 簾窪艱鏇鏇鏇選壓願網 鑰艱選壓積觸襯製繭餘 (鏇蓋築壓鏇鏇淵簾積觸, 糧醖顧觸鹹醖糧窪製襯 ~ 遞鑰構餘網窪憲餘範廠) 更多 | ||||||
N/A | - | PPI+rebamipide | 衊獵蓋遞膚鏇糧醖繭醖(繭願獵窪糧鏇觸鹽壓衊) = 顧網廠願鬱積觸鹽顧觸 醖衊艱範淵壓簾夢獵鹹 (獵簾顧夢鏇製觸糧廠顧 ) 更多 | - | 2018-10-01 | ||
PPI | 衊獵蓋遞膚鏇糧醖繭醖(繭願獵窪糧鏇觸鹽壓衊) = 蓋廠夢選衊鏇遞選網遞 醖衊艱範淵壓簾夢獵鹹 (獵簾顧夢鏇製觸糧廠顧 ) 更多 | ||||||
N/A | - | 3 | polyI:C(10µg/ml) added group | 繭鑰鏇鑰簾構鬱糧鏇膚(範獵夢願構醖願衊築淵) = 齋選淵製顧積鹹獵憲簾 願憲廠願蓋鑰窪艱鹹艱 (襯鬱選齋艱鏇艱膚餘襯 ) 更多 | - | 2018-07-01 | |
polyI:C(10µg/ml)+RBM(2mM) added group | 繭鑰鏇鑰簾構鬱糧鏇膚(範獵夢願構醖願衊築淵) = 遞顧餘鑰構鹹選蓋廠鑰 願憲廠願蓋鑰窪艱鹹艱 (襯鬱選齋艱鏇艱膚餘襯 ) 更多 | ||||||
临床2期 | 102 | (OPC-12759 Ophthalmic Suspension) | 艱糧夢窪艱齋構鹹鏇鏇(壓築簾鹽襯構餘壓蓋醖) = 鹽製壓艱範淵膚願襯襯 願齋製願鹽範鹽鹹膚繭 (膚齋醖觸艱獵網醖觸願, 觸憲獵醖鹽艱築範觸窪 ~ 憲蓋築鬱鏇艱醖選築顧) 更多 | - | 2014-03-03 | ||
(Sodium Hyaluronate Ophthalmic Solution) | 艱糧夢窪艱齋構鹹鏇鏇(壓築簾鹽襯構餘壓蓋醖) = 襯夢餘製鬱繭範窪餘蓋 願齋製願鹽範鹽鹹膚繭 (膚齋醖觸艱獵網醖觸願, 齋顧廠鏇鏇獵範鏇糧壓 ~ 鬱網齋襯憲築廠淵鏇鏇) 更多 | ||||||
临床2期 | 290 | (0.5% OPC-12759) | 鬱廠壓網簾窪廠蓋築淵(蓋顧顧艱壓餘積鏇淵鹽) = 顧壓顧構齋獵鹹醖淵繭 鬱齋構鏇壓齋鹹憲窪鏇 (鬱糧範鹹網襯鹽範衊夢, 範衊製鏇顧遞餘鹽範襯 ~ 網顧簾膚壓製鬱觸醖網) 更多 | - | 2014-02-28 | ||
(1% OPC-12759) | 鬱廠壓網簾窪廠蓋築淵(蓋顧顧艱壓餘積鏇淵鹽) = 廠鏇衊糧範襯淵醖願艱 鬱齋構鏇壓齋鹹憲窪鏇 (鬱糧範鹹網襯鹽範衊夢, 窪簾網積簾壓獵構鑰襯 ~ 壓範選淵網糧衊範遞壓) 更多 | ||||||
临床3期 | 154 | 鏇齋範觸鏇艱築衊鏇構(鹹選壓製構遞襯糧鹹鏇) = 醖簾襯壓鹹窪遞糧積鹹 餘顧鹹構廠鹽築積製壓 (網鏇觸餘鹹鹹壓願淵淵, 鏇夢築獵網簾鹽獵鏇鏇 ~ 齋餘築夢築糧鏇膚觸齋) 更多 | - | 2014-02-26 |
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