Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine(Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine)

概要

基本信息

药物类型

小分子化药

别名

Cholesteryl palmitate/colfosceril palmitate、Colfosceril-palmitate/cholesteryl-palmitate、Dipalmitoylphosphatidylcholine/cholesteryl-palmitate

+ [3]

靶点-

作用方式-

作用机制-

治疗领域

耳鼻咽喉疾病神经系统疾病其他疾病

在研适应症-

非在研适应症

急性中耳炎耳痛

原研机构

Otodyne, Inc.

在研机构-

非在研机构

Eledon Pharmaceuticals, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的临床试验

NCT03818815

/ Completed临床2期

A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.

开始日期2019-02-21

申办/合作机构

Eledon Pharmaceuticals, Inc.

NCT03828149

/ Completed临床1期

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

开始日期2019-02-08

申办/合作机构

Eledon Pharmaceuticals, Inc.

NCT03766373

/ Completed临床1期

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

开始日期2019-01-07

申办/合作机构

Eledon Pharmaceuticals, Inc.

100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的临床结果

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100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的转化医学

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100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的专利（医药）

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7

项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的文献（医药）

2024-08-01·Journal of Pharmaceutical Sciences

Application of Response Surface Methodology Using Face-centered Central Composite Design for Studying Long-Term Stability of Gliclazide-Loaded Multiparticulate Systems

Article

作者: Elsayed, Ebtesam W ; Emam, Maha F

The appropriate design of experiments (DoE) could support post-approval lean-stability approaches. A three-factor three-level face-centered design was constructed to evaluate the long-term stability of gliclazide (GLZ) alginate-gelatin beads. The formulation variables were GLZ%(X₁), alginate:gelatin ratio(X₂), and glutaraldehyde%(X₃). The studied responses included GLZ release at predefined intervals in 0.1 N HCl (2 h) followed by phosphate buffer (pH 7.4). Model-dependent and independent approaches were utilized for comparison. DoE-model validation and reduction were implemented. All the studied formulations showed non-significant changes in the particle size (p > 0.05) and most of them showed similar release profiles before and after storage. The directions of the relationships between the factors' main effects and the responses (Y₁:Q_0.5_h, Y₂:Q_2h, and Y₃:Q_4h) remained unchanged after storage. The optimal factor settings based on the proposed optimization criteria were defined. The optimized formulations (OP-1 and OP-2) showed non-significant changes in the particle size after storage. The release profiles and kinetics of OP-1 and OP-2 remained unchanged after storage. No chemical change was indicated (FT-IR). DSC-thermograms of OP-1 indicated GLZ conversion to a more stable polymorph after storage. While OP-2 showed a change in GLZ crystallinity. The stored and fresh beads' surfaces after GLZ release were almost similar. DoE could be utilized to evaluate, optimize, and predict the effects of different formulation variables on the long-term stability of GLZ alginate-gelatin beads.

2021-12-01·Pediatrics2区 · 医学

Intranasal Surfactant for Acute Otitis Media: A Randomized Trial

2区 · 医学

Article

作者: Martin, Judith M. ; Pogoda, Janice M. ; Liu, Hui ; Hoberman, Alejandro ; Haralam, Mary Ann ; Muniz, Gysella B. ; Shaikh, Nader ; Shope, Timothy R. ; Bhatnagar, Sonika

BACKGROUNDAcute otitis media (AOM) is the most frequent reason for children to be prescribed antimicrobial treatment. Surfactants are naturally occurring substances that may restore the eustachian tube’s function and potentially enhance resolution of AOM.METHODSThis was a phase 2a, single-center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antimicrobial agents for treating AOM in young children. We randomly assigned 103 children aged 6 to 24 months with AOM to receive either OP0201 or placebo twice daily for 10 days. All children received amoxicillin-clavulanate 90/6.4 mg/kg per day in 2 divided doses for 10 days. Participants were managed for up to 1 month. Postrandomization visits occurred between days 4 and 6 (visit 2), days 12 and 14 (visit 3), and days 26 and 30 (visit 4). Primary efficacy endpoints were resolution of a bulging tympanic membrane at visit 2 and resolution of middle-ear effusion at visit 3.RESULTSNo clinically meaningful differences between treatment groups were apparent for primary or secondary endpoints. There were no safety concerns identified.CONCLUSIONSIn young children with AOM, intranasally administered surfactant (OP0201) did not improve clinical outcomes. Further research may be warranted among children with persistent middle-ear effusion.

2019-11-01·International Journal of Biological Macromolecules

Effect of okra polysaccharide on the spermatogenesis of KKAy mice

Article

作者: Chen, Jing

In this work, a water-soluble okra polysaccharide (OP-2) was prepared by hot water extraction, and the effects of OP-2 on the spermatogenesis of KKAy mice were investigated. Forty eight KKAy mice with similar initial body weights and lipid and blood glucose levels were randomly divided into four groups, i.e., one control group and three OP-2-treatment groups (treated with 50 mg/kg, 100 mg/kg and 150 mg/kg OP-2, respectively). Oral OP-2 administration increased high-density lipoprotein cholesterol, protein and superoxide dismutase levels in testis, sperm density, sperm movement and rate of normal morphology of KKAy mice and decreased serum total cholesterol, low-density lipoprotein cholesterol, fasting blood glucose and insulin levels and nitrate oxide in testis of KKAy mice. The results indicated that OP-2 can effectively ameliorate the spermatogenesis of KKAy mice and may be used as an adjuvant drug for infertility with diabetes mellitus.

100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性中耳炎	临床2期	美国	Eledon Pharmaceuticals, Inc.	2019-02-21
耳痛	临床2期	美国	Eledon Pharmaceuticals, Inc.	2019-01-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03818815 (Pubmed) 人工标引	临床2期	急性中耳炎	103	amoxicillin-clavulanate+OP0201	(顧觸淵鏇齋網淵齋顧範) = No clinically meaningful differences 鹽構衊鏇壓廠繭鬱艱獵 (壓鹹廠齋窪憲鏇窪鏇觸 )	不佳	2021-12-01
				amoxicillin-clavulanate+Placebo
NCT03818815 (CTgov)	临床2期	急性中耳炎	103	OP0201+Amoxicillin-clavulanate	壓選觸願構襯簾願糧簾(淵鑰憲廠選選鬱顧襯願) = 鏇憲獵窪鏇顧膚製觸艱醖顧鑰築壓膚選簾糧構 (獵餘壓糧餘鏇範鏇膚襯, 鬱網遞糧蓋艱窪窪顧襯 ~ 淵窪衊鬱鹽鏇築願繭蓋) 更多	-	2020-08-11
NCT03828149 (CTgov)	临床1期	-	17	Drug:OP0201 (Drug: OP0201)	(獵艱鑰醖窪範夢窪選餘) = 餘齋築繭鬱選窪鑰製觸窪鬱膚壓壓壓醖範襯襯 (願廠蓋網製築淵鬱廠窪, 繭遞獵鹹衊鹹鏇醖簾鏇 ~ 憲觸壓鏇製蓋選鑰鏇膚)	-	2019-12-30
				Drug: Placebo (Drug: Placebo)	(獵艱鑰醖窪範夢窪選餘) = 獵鏇網網網齋襯築廠膚窪鬱膚壓壓壓醖範襯襯 (願廠蓋網製築淵鬱廠窪, 願顧廠網遞餘齋遞蓋遞 ~ 鹽衊遞糧膚構顧鬱艱遞)
NCT03766373 (CTgov)	临床1期	急性中耳炎 \| 耳痛	24	Drug: OP0201 20mg (Drug: OP0201)	簾構遞壓蓋糧衊夢憲醖(網鹽襯夢願糧鬱膚築鹽) = 淵壓艱選鬱醖遞觸築網顧糧鹽膚夢製艱襯廠齋 (獵蓋艱鹽淵鏇蓋鑰繭構, 觸構齋顧夢醖鹹廠夢衊 ~ 選衊齋願鹹淵艱廠醖觸) 更多	-	2019-11-21
				Drug: Placebo 0mg (Drug: Placebo)	簾構遞壓蓋糧衊夢憲醖(網鹽襯夢願糧鬱膚築鹽) = 憲築製製憲衊膚窪範艱顧糧鹽膚夢製艱襯廠齋 (獵蓋艱鹽淵鏇蓋鑰繭構, 齋願築選壓繭遞襯網鏇 ~ 積膚窪淵鹹繭夢選構糧) 更多