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Not yet recruiting Phase 4 Interventional Accepts healthy volunteers

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.

ClinicalTrials.gov ID: NCT07801066

Public ClinicalTrials.gov record NCT07801066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics Following Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants: A Bootstrap Validation.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07801066
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Primus Pharmaceuticals
Industry
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2026
Primary completion
Jan 14, 2027
Completion
Jan 14, 2027
Last update posted
Sep 2, 2026

2026 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
AMR Clinical - Columbus Columbus Ohio 43213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07801066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07801066 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →