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NOT YET RECRUITING
NCT07801066
PHASE4

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.

Sponsor: Primus Pharmaceuticals

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-15

Completion Date

2027-01-15

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DRUG

Metaxalone 640 mg

Dose micronized 640 mg

DRUG

Metaxalone 800 MG

The dose is 800 mg

Locations (1)

AMR Clinical - Columbus

Columbus, Ohio, United States