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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.
Sponsor: Primus Pharmaceuticals
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
Metaxalone 640 mg
Dose micronized 640 mg
Metaxalone 800 MG
The dose is 800 mg
Locations (1)
AMR Clinical - Columbus
Columbus, Ohio, United States