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Safety and Efficacy of a Combination Product for the Prevention of Veisalgia

NCT02737397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-07-19

Study results available
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Summary

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.

Conditions

  • Veisalgia

Interventions

DRUG

JMI-001 (SJP-304 and SJP-223)

DRUG

SJP-304

DRUG

SJP-223

DRUG

placebo

Sponsors & Collaborators

  • Sen-Jam Pharmaceutical

    lead OTHER

Principal Investigators

  • Magdy L Shenouda · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737397 on ClinicalTrials.gov