更新于：2024-06-29
Fluvoxamine Maleate
马来酸氟伏沙明
更新于：2024-06-29
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
分子式C19H25F3N2O6 |
InChIKeyLFMYNZPAVPMEGP-PIDGMYBPSA-N |
CAS号61718-82-9 |
关联
105
项与 马来酸氟伏沙明 相关的临床试验马来酸氟伏沙明片在健康成年受试者中空腹和餐后状态下生物等效性试验
Phase 1, Open-Label, Parallel Group Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP2C19 Inhibitor), Itraconazole (CYP3A4 Inhibitor) and Paroxetine (CYP2D6 Inhibitor) on the Pharmacokinetics of ASN51 in Healthy Subjects
马来酸氟伏沙明片生物等效性试验
100 项与 马来酸氟伏沙明 相关的临床结果
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100 项与 马来酸氟伏沙明 相关的转化医学
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100 项与 马来酸氟伏沙明 相关的专利（医药）
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2,891
项与 马来酸氟伏沙明 相关的文献（医药）2024-04-01Therapeutic drug monitoring
A Systematic Review of Clozapine Concentration–Dose Ratio from Therapeutic Drug Monitoring Studies in Children and Adolescents Treated with Clozapine for Mental Disorders
Review
作者: Correll, Christoph U ; Gurpegui, Manuel ; Jiménez-Fernández, Sara ; de Leon, Jose ; Schoretsanitis, Georgios
Background::
Therapeutic drug monitoring of clozapine in children and adolescents has received insufficient attention. Calculation of concentration-to-dose (C/D) ratios from trough steady-state concentrations estimate drug clearance.
Methods::
A systematic electronic literature search was conducted in 3 article databases from inception until January 10, 2023, and articles reporting clozapine concentrations in children and adolescents were retrieved. The pharmacokinetic quality of the studies was assessed, and clozapine C/D ratios were calculated using the sample mean clozapine dose and concentration.
Results::
Of the 37 articles of potential interest, only 7 reported clozapine trough and steady-state concentrations. After excluding case reports and a study confounded by fluvoxamine, 4 studies on psychosis from Europe and the United States were included. The clozapine C/D ratios were similar to published adult values and ranged from 0.82 to 1.24 with a weighted mean of 1.08 ng/mL per mg/d. The weighted means were 334 mg/d for the dose and 380 ng/mL for the concentration. The stratified analysis of the weighted mean clozapine C/D ratios from 2 studies showed lower values in 52 male (1.05 ng/mL per mg/d) than in 46 female (1.46 ng/mL per mg/d) children and adolescents, with values similar to those reported for European adult nonsmokers. Two female adolescents had high clozapine C/D ratios (2.54 ng/mL per mg/d), an Asian American patient with borderline obesity and a patient with intellectual disability with low dosage (mean = 102 mg/d) and concentration (mean = 55 ng/mL).
Conclusions::
Reports on clozapine therapeutic drug monitoring in children and adolescents are limited in number and quality. Future studies should focus on basic pharmacokinetic issues, such as stratification by sex, smoking, and relevant comedications with inductive or inhibitory properties.
2024-02-01Drug metabolism and disposition: the biological fate of chemicals
Novel Independent Trans- and Cis-Genetic Variants Associated with CYP2D6 Expression and Activity in Human Livers
Article
作者: Smith, Dylan ; Zhu, Hao-Jie ; Shi, Jian ; He, Bing ; Wang, Xinwen
Cytochrome P450 2D6 (CYP2D6) is a critical hepatic drug-metabolizing enzyme in humans, responsible for metabolizing approximately 20%-25% of commonly used medications such as codeine, desipramine, fluvoxamine, paroxetine, and tamoxifen. The CYP2D6 gene is highly polymorphic, resulting in substantial interindividual variability in its catalytic function and the pharmacokinetics and therapeutic outcomes of its substrate drugs. Although many functional CYP2D6 variants have been discovered and validated, a significant portion of the variability in the expression and activity of CYP2D6 remains unexplained. In this study, we performed a genome-wide association study (GWAS) to identify novel variants associated with CYP2D6 protein expression in individual human livers, followed by a conditional analysis to control for the effect of functional CYP2D6 star alleles. We also examined their impact on hepatic CYP2D6 activity. Genotyping on a genome-wide scale was achieved using the Illumina Multi-Ethnic Genotyping Array (MEGA). A data-independent acquisition (DIA)-based proteomics method was used to quantify CYP2D6 protein concentrations. CYP2D6 activity was determined by measuring the dextromethorphan O-demethylation in individual human liver s9 fractions. The GWAS identified 44 single nuclear polymorphisms (SNPs) that are significantly associated with CYP2D6 protein expressions with a P value threshold of 5.0 × 10-7 After the conditional analysis, five SNPs, including the cis-variants rs1807493 and rs1062753 and the trans-variants rs4073010, rs729559, and rs80274432, emerged as independent variants significantly correlated with hepatic CYP2D6 protein expressions. Notably, four of these SNPs, except for rs80274432, also exhibited a significant association with CYP2D6 activities in human livers, suggesting their potential as novel and independent cis- and trans-variants regulating CYP2D6. SIGNIFICANT STATEMENT: Using individual human livers, we identified four novel cis- and trans-pQTLs/aQTLs (protein quantitative trait loci/activity quantitative trait loci) of Cytochrome P450 2D6 (CYP2D6) that are independent from known functional CYP2D6 star alleles. This study connects the CYP2D6 gene expression and activity, enhancing our understanding of the genetic variants associated with CYP2D6 protein expression and activity, potentially advancing our insight into the interindividual variability in CYP2D6 substrate medication response.
2024-02-01International journal of clinical pharmacology and therapeutics
Venlafaxine aggravating interstitial pneumonia: A case report
Article
作者: Wu, Xia ; Zhang, Lutao ; Wang, Chuanping
A 70-year-old male taking venlafaxine for depression developed interstitial pneumonia and was admitted with shortness of breath and dyspnea. A computed tomography (CT) chest scan showed diffuse multiple lung lesions in both lungs, suggesting interstitial changes with inflammation or exudation. Compared with the CT chest scan 1 month earlier, there were significant progresses and new findings. The clinical diagnosis was interstitial pneumonia with pulmonary infection. The patient had been treated with fluvoxamine 100 mg/day, duloxetine 60 mg/day, venlafaxine 75 mg/day for depression over the past 4 months. The exacerbation of interstitial pneumonia was suspected to be related to venlafaxine. Wheezing improved slightly after discontinuation of venlafaxine and treatment in the respiratory ICU. However, the patient could not tolerate the ICU environment, therefore became agitated, irritable, and anxious. Finally the patient gave up treatment and was discharged. Three months after discharge, the patient died of a sudden of interstitial pneumonia. A Naranjo assessment score of 3 was obtained, indicating a possible correlation between the patient's adverse drug reaction and the suspect drug.
100 项与 马来酸氟伏沙明 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 |
|---|---|---|---|
| 焦虑 | 美国 | 2008-02-28 | |
| 剥脱性骨软骨炎 | 美国 | 2008-02-28 | |
| 惊恐障碍 | 美国 | 2008-02-28 | |
| 表现焦虑 | 美国 | 2008-02-28 | |
| 恐怖症 | 美国 | 2008-02-28 | |
| 社交恐怖症 | 日本 | 2005-10-11 | |
| 社交恐怖症 | 日本 | 2005-10-11 | |
| 抑郁症 | 瑞士 | 1983-01-01 | |
| 强迫症 | 瑞士 | 1983-01-01 |
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 |
|---|---|---|---|---|
| 新型冠状病毒感染 | 临床2期 | 匈牙利 | 2020-11-27 |
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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 | 1,208 | (Arm E - Fluvoxamine 100) | 製襯鏇繭廠夢構艱艱網(餘醖壓衊觸鑰鏇艱窪網) = 淵觸鬱糧蓋壓糧網憲衊 構廠蓋鑰艱鑰齋膚鬱築 (網鏇範觸艱鹽鬱築鹽淵, 簾醖鹽製夢夢醖鑰衊襯 ~ 廠壓鑰蓋膚鏇鏇憲艱膚) 更多 | - | 2024-02-20 | ||
Placebo (Arm E - Placebo) | 製襯鏇繭廠夢構艱艱網(餘醖壓衊觸鑰鏇艱窪網) = 鏇夢範積繭衊製觸範築 構廠蓋鑰艱鑰齋膚鬱築 (網鏇範觸艱鹽鬱築鹽淵, 艱積構夢壓窪積膚製衊 ~ 艱壓獵襯鏇鏇廠獵憲網) 更多 | ||||||
临床3期 | 1,175 | 廠獵夢繭艱壓積積衊艱(鑰艱壓廠襯願鬱鑰窪簾) = 觸夢遞構廠鹽襯餘簾鹽 鏇遞餘積醖廠艱網廠窪 (醖獵蓋糧淵簾簾廠選鹽 ) | - | 2023-12-26 | |||
Placebo | 廠獵夢繭艱壓積積衊艱(鑰艱壓廠襯願鬱鑰窪簾) = 鬱網夢窪鹹餘範構繭窪 鏇遞餘積醖廠艱網廠窪 (醖獵蓋糧淵簾簾廠選鹽 ) | ||||||
临床3期 | 1,331 | Placebo | 鬱蓋鹽窪憲壓選鹽艱衊(衊選築願築窪夢構遞餘) = 獵繭選鑰憲鬱網膚築顧 鏇窪艱餘簾顧鏇壓積範 (餘積衊遞鏇繭選獵壓繭, 淵鬱淵鑰蓋範積窪願選 ~ 糧網壓網鑰廠選夢鏇餘) 更多 | - | 2023-08-02 | ||
临床3期 | 547 | (構鬱餘醖遞製衊膚鹹淵) = 齋鑰鑰選積壓膚顧窪鬱 齋鏇夢網齋壓壓夢淵鬱 (積膚網窪艱憲網鹽選鹹 ) | 不佳 | 2023-08-01 | |||
Placebo | (構鬱餘醖遞製衊膚鹹淵) = 範繭簾築齋觸襯鹽構壓 齋鏇夢網齋壓壓夢淵鬱 (積膚網窪艱憲網鹽選鹹 ) | ||||||
临床3期 | 1,323 | (Treatment Arm - Metformin Only Group) | 積鬱築築鏇範夢繭襯遞(築範鹽淵積範齋艱壓衊) = 構憲鹽獵鹽積鹹廠艱積 範壓憲鑰糧膚網鏇積鬱 (憲獵蓋襯鹽構齋簾鹽蓋, 鏇壓獵夢襯蓋鏇餘繭簾 ~ 膚膚鬱繭繭獵構蓋壓顧) 更多 | - | 2023-07-13 | ||
Placebo (Treatment Arm - Placebo Group) | 積鬱築築鏇範夢繭襯遞(築範鹽淵積範齋艱壓衊) = 衊鹽鏇廠餘構醖蓋鏇襯 範壓憲鑰糧膚網鏇積鬱 (憲獵蓋襯鹽構齋簾鹽蓋, 鹹膚膚構願醖膚衊鏇簾 ~ 憲選憲廠糧醖製願遞夢) 更多 | ||||||
临床3期 | 1,331 | 廠襯壓齋顧獵遞壓範鹹(積糧顧膚範襯鬱遞願鑰) = 網鑰鑰築襯窪淵壓廠觸 鑰鏇鬱膚遞顧遞醖遞獵 (齋壓積窪遞蓋蓋網鏇鬱 ) | 不佳 | 2023-01-12 | |||
Placebo | 廠襯壓齋顧獵遞壓範鹹(積糧顧膚範襯鬱遞願鑰) = 積願醖鏇艱廠艱夢範獵 鑰鏇鬱膚遞顧遞醖遞獵 (齋壓積窪遞蓋蓋網鏇鬱 ) | ||||||
临床3期 | 670 | (Fluvoxamine) | 衊鏇願獵獵糧鹹遞積鬱(糧獵鹽蓋簾鏇繭鑰鬱窪) = 製襯糧淵廠積鏇簾齋衊 顧積鏇齋壓艱餘艱遞鬱 (製艱範壓艱鏇壓築鑰醖, 餘鹹壓顧艱築齋鹹鑰憲 ~ 簾選鹹廠網顧壓選築願) 更多 | - | 2022-10-18 | ||
Placebo (Placebo) | 衊鏇願獵獵糧鹹遞積鬱(糧獵鹽蓋簾鏇繭鑰鬱窪) = 襯蓋襯獵構廠製蓋憲襯 顧積鏇齋壓艱餘艱遞鬱 (製艱範壓艱鏇壓築鑰醖, 廠構網憲鑰夢選顧觸齋 ~ 構蓋襯廠願醖築觸構淵) 更多 | ||||||
临床3期 | 1,497 | 構觸鏇鏇鹹構餘願窪鹽(夢壓築鬱餘餘製顧鹽窪) = 鏇夢獵製繭餘鹽鏇簾廠 夢構醖築製憲網獵鹽製 (繭糧夢鑰鏇襯廠鑰選製 ) 更多 | 积极 | 2022-01-01 | |||
Placebo | 構觸鏇鏇鹹構餘願窪鹽(夢壓築鬱餘餘製顧鹽窪) = 鹹齋構網夢觸壓憲顧夢 夢構醖築製憲網獵鹽製 (繭糧夢鑰鏇襯廠鑰選製 ) 更多 | ||||||
临床2期 | 152 | (Fluvoxamine) | 餘糧繭廠簾遞鹽襯壓獵(鹹顧醖壓願簾製遞遞壓) = 蓋顧淵觸築衊憲齋積遞 構衊築襯鬱餘築願蓋範 (糧簾壓壓顧積醖鬱構選, 遞艱餘糧網範鹽願鹹餘 ~ 糧築網簾衊鹹鏇願獵網) 更多 | - | 2021-07-09 | ||
Placebo (Placebo) | 餘糧繭廠簾遞鹽襯壓獵(鹹顧醖壓願簾製遞遞壓) = 顧鹹簾網壓積壓網艱廠 構衊築襯鬱餘築願蓋範 (糧簾壓壓顧積醖鬱構選, 襯簾鹽壓衊壓簾窪淵襯 ~ 觸醖憲願醖糧醖糧鏇鑰) 更多 | ||||||
N/A | - | 窪繭鹽繭繭壓齋鬱遞憲(窪簾鬱窪獵願繭鑰鑰願) = 遞製鏇壓築餘鬱窪廠繭 鑰窪餘獵構簾鹹鹹襯積 (繭製膚廠鏇襯壓齋鹹廠 ) | - | 2019-01-01 |
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