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Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

NCT03183297 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Veisalgia

Interventions

DRUG

JMI-001

JMI-001, a combination product of naproxen and fexofenadine

DRUG

Naproxen

Naproxen sodium 220mg

DRUG

Fexofenadine

Fexofenadine 60mg

DRUG

placebo

placebo comparator

Sponsors & Collaborators

  • Sen-Jam Pharmaceutical

    lead OTHER

Principal Investigators

  • Magdy L Shenouda, MD · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2017-10-31
Completion
2017-12-31
FDA Drug
Yes

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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 NCT03183297 on ClinicalTrials.gov