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Healthy Participants Will Take One Dose of a Drug After Eating a Meal, Then Test for Drowsiness and Fall Risk With Brain Wave Monitoring Throughout the Testing. Participants Will Take a Second Dose of the Drug With the Same Testing.

NCT07801066 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-09-03

No results posted yet for this study

Summary

Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.

Conditions

  • Comparison Between 2 Doses of Metaxalone to Measure Drowsiness, Cognition and Fall Risk

Interventions

DRUG

Metaxalone 640 mg

Dose micronized 640 mg

DRUG

Metaxalone 800 MG

The dose is 800 mg

Sponsors & Collaborators

  • AMR Clinical

    collaborator UNKNOWN

  • Primus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-01-15
Completion
2027-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07801066 on ClinicalTrials.gov