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.

Start Date01 Aug 2017

Sponsor / Collaborator

Sen-Jam Pharmaceutical LLCStartup

NCT02737397 / CompletedPhase 2

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.

Start Date01 Mar 2016

Sponsor / Collaborator

Sen-Jam Pharmaceutical LLCStartup

100 Clinical Results associated with Fexofenadine/Naproxen

100 Translational Medicine associated with Fexofenadine/Naproxen

100 Patents (Medical) associated with Fexofenadine/Naproxen

Literatures (Medical) associated with Fexofenadine/Naproxen

01 Jan 2024·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

Author: 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 Deals associated with Fexofenadine/Naproxen

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Alcohol-Related Disorders	Phase 2	-	Jmi Capital Group Llc	-
Hangover from alcohol	Phase 1	-	Sen-Jam Pharmaceutical LLCStartup	01 Mar 2016
Pain	Phase 1	-	Sen-Jam Pharmaceutical LLCStartup	01 Mar 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02737397 (CTgov)	Phase 2	Hangover from alcohol \| Pain	13	SJP-223)+JMI-001 (SJP-304 (Pain Medicine and Antihistamine)	hdatucuifn(scbqmsqmdt) = dgybkujumc nfedzvlcse (agrckcxsak, dkgogkvdrn - xeouvkhgpv) View more	-	19 Jul 2018
				placebo (Pain Medicine)	hdatucuifn(scbqmsqmdt) = wwbzopiviv nfedzvlcse (agrckcxsak, vgewvwoecj - cyuowmchmi) View more

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