A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation

This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
FOV1101-00 concentration 1 and Pred Mild®
FOV1101-00 concentration 2 and Pred Mild®
Vehicle of FOV1101-00 and Pred Forte®
Vehicle of FOV1101-00 and Vehicle of FOV1101-00

开始日期2009-01-01

申办/合作机构

Fovea Pharmaceuticals SA

100 项与环孢素/泼尼松龙相关的临床结果

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100 项与环孢素/泼尼松龙相关的转化医学

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100 项与环孢素/泼尼松龙相关的专利（医药）

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项与环孢素/泼尼松龙相关的文献（医药）

2020-01-13·Journal of Pharmacy and Pharmacology

PXR haplotype clusters will affect the pharmacokinetics of ciclosporin in Chinese renal transplant recipients

Article

作者: Li, Danying ; Ge, Weihong ; Zhu, Huaijun ; Luo, Xuemei

AbstractObjectivePXR was reported to be the key nuclear receptor regulating the expression of metabolizing enzymes and transporters. The aim of this study was to evaluate the influence of PXR haplotype clusters on ciclosporin concentration in Chinese renal transplant recipients during the early stage after transplantation.MethodsA total of 98 recipients receiving ciclosporin were genotyped by PCR-RFLP, and the ciclosporin concentration was determined by EMIT.Key findingsThe frequency of IVS2+55A>G, IVS2+78A>G, IVS6-17C>T, 1792A>G, 1944T>C and 2654T>C variant alleles was 0.343, 0.332, 0.378, 0.515, 0.520 and 0.393, which fitted Hardy–Weinberg equilibrium. Only the IVS6-17C>T and 2654T>C were significantly associated with the ciclosporin C2/D during the end of the first month. The mean ciclosporin C2/D level of the PXR*1B haplotype clusters was 1.3-fold and 1.2-fold higher compared with the *1A and *1C. No significant difference was observed in CsA C2/D between the PXR*1A and PXR*1C. We found no difference in C0/D among the six genotypes or the three haplotype clusters.ConclusionsThe PXR*1B in Chinese renal transplant patients was associated with ciclosporin concentration. Genetic polymorphisms and specific haplotype clusters in PXR could have significant contributory roles in affecting interethnic variations in drug disposition in the Chinese population.

100 项与环孢素/泼尼松龙相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
眼部炎症	临床2期	美国	Fovea Pharmaceuticals SA	2009-01-01
变应性结膜炎	临床2期	-	Fovea Pharmaceuticals SA	-
变应性结膜炎	临床2期	-	CombinatoRx, Inc.	-
变应性结膜炎	临床2期	-	CombinatoRx, Inc.	-
变应性结膜炎	临床2期	-	Fovea Pharmaceuticals SA	-

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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


MECANO Trial (Pubmed \| MMWR Morb Mortal Wkly Rep)	N/A	-	-	Prednisolone/Cyclosporine A	鏇選糧製選糧窪觸餘願(醖範構製膚衊襯製獵鏇) = 餘鹹範壓範網餘鏇選襯艱鬱選餘糧壓夢夢鬱窪 (膚簾醖鹹餘製鏇願觸網 )	-	2017-04-01
				Prednisolone/Everolimus	鏇選糧製選糧窪觸餘願(醖範構製膚衊襯製獵鏇) = 製鏇遞淵繭膚淵憲夢壓艱鬱選餘糧壓夢夢鬱窪 (膚簾醖鹹餘製鏇願觸網 )