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.

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.

Eligibility

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Healthy adults aged 18 to 55 years old * Weigh at least 120 pounds * Medically healthy * Able to sign and date informed consent form Exclusion Criteria: * Current use of any medications known to affect the sleep-wake cycle * Sleep disorder diagnosis * Positive urine test for drugs * Known history of alcohol use disorder * Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia * Having difficulty eating high fat meal * Participants who are pregnant, nursing or intending to become pregnant during the period of study. * Blood Press…

Interventions

Drug
Metaxalone 640 mg
Dose micronized 640 mg
Drug
Metaxalone 800 MG
The dose is 800 mg

Location

AMR Clinical - Columbus
Columbus, Ohio
jim.sanders@amr-clinical.com 614-683-5800

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.

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions