A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.

开始日期2017-08-01

申办/合作机构

Sen-Jam Pharmaceutical LLC初创企业

NCT02737397 / Completed临床2期

A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Volunteers

The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.

开始日期2016-03-01

申办/合作机构

Sen-Jam Pharmaceutical LLC初创企业

100 项与非索非那定/萘普生相关的临床结果

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100 项与非索非那定/萘普生相关的转化医学

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100 项与非索非那定/萘普生相关的专利（医药）

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项与非索非那定/萘普生相关的文献（医药）

2024-01-01·Heliyon

Comparison of the efficacy of combined budesonide and fexofenadine versus combined fluticasone propionate and fexofenadine on the expression of class-4 semaphorins and their receptors in the peripheral blood cells of patients with allergic rhinitis

Article

作者: Gorgin Karaji, Ali ; Asadi, Gelayol ; Faryadi, Elham ; Rezaei Varmaziar, Fatemeh ; Feizollahi, Parisa ; Salari, Farhad ; Rajabinejad, Misagh ; Falahi, Sara ; Rezaiemanesh, Alireza

BackgroundAllergic rhinitis (AR) is a common immunoglobulin (Ig) E-mediated disease. This study aimed to evaluate the gene expression levels of class 4 semaphorins and their receptors in AR patients before and after treatment with budesonide and fexofenadine (B/F) compared to fluticasone propionate and fexofenadine (FP/F).MethodsIn this study, 29 AR patients (age 34.4 ± 1.2 years, 18 men and 11 women) were treated with B/F, and 24 AR patients (age 32.8 ± 1.9 years, 15 men and 9 women) were treated with FP/F for one month. Before and after treatment, peripheral blood samples were taken from patients. The expression levels of SEMA4A, SEMA4C, SEMA4D, Plexin-B2, and Plexin-D1 genes were measured using the qPCR method. In addition, the serum levels of IgE were measured using an enzyme-linked immunosorbent assay (ELISA).ResultsThe expression levels of SEMA4A (P = 0.011), 4C (P = 0.017), Plexin-B2 (P = 0.0005), and Plexin-D1 (P = 0.008) remarkably increased in AR patients treated with B/F. Our results show a significant reduction in the gene expression levels of SEMA4A (P = 0.002), 4C (P = 0.014), 4D (P = 0.003), Plexin-B2 (P = 0.033), and Plexin-D1 (P = 0.035) after treatment with FP/F. The serum levels of IgE increased in FP/F treated group (P = 0.017) and conversely decreased in the treated group with B/F (P = 0.019). Moreover, the percentages of eosinophils were reduced in both FP/F and B/F groups (P = 0.015 and P = 0.0001, respectively).ConclusionIn conclusion, concomitant use of fexofenadine and fluticasone propionate reduced SEMA4A, 4C, 4D, Plexin-B2, and Plexin-D1, while the SEMA4A, 4C, Plexin-B2, and Plexin-D1 gene expression levels were increased in the patient group treated with B/F.

100 项与非索非那定/萘普生相关的药物交易

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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
酒精相关疾病	临床2期	-	Jmi Capital Group Llc	-
宿醉	临床1期	-	Sen-Jam Pharmaceutical LLC初创企业	2016-03-01
疼痛	临床1期	-	Sen-Jam Pharmaceutical LLC初创企业	2016-03-01

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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


NCT02737397 (CTgov)	临床2期	宿醉 \| 疼痛	13	SJP-223)+JMI-001 (SJP-304 (Pain Medicine and Antihistamine)	獵鬱醖鬱夢顧憲膚積壓(構艱選膚鏇構鑰廠鏇網) = 鹽膚範願鬱構廠衊糧齋製鑰範構鹽窪蓋願鏇積 (遞夢鬱衊鑰願夢襯襯觸, 鑰醖範艱蓋獵築顧膚齋 ~ 鹽鏇繭構遞願淵齋襯憲) 更多	-	2018-07-19
				placebo (Pain Medicine)	獵鬱醖鬱夢顧憲膚積壓(構艱選膚鏇構鑰廠鏇網) = 鹽夢糧網鏇鹹蓋獵觸繭製鑰範構鹽窪蓋願鏇積 (遞夢鬱衊鑰願夢襯襯觸, 膚齋選鑰構餘遞範夢遞 ~ 餘繭鑰齋壓淵襯艱選餘) 更多