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NCT07801066
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.
Conditions: Comparison Between 2 Doses of Metaxalone to Measure Drowsiness, Cognition and Fall Risk
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 20
Sponsor: Primus Pharmaceuticals
Location: AMR Clinical - Columbus Columbus Ohio
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 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 Pressure \> 160/110 or \100 or \< 50/ beats per minute.
* Having a history of seizure disorder or epilepsy.
Source: ClinicalTrials.gov (NCT07801066). StuddyBuddy aggregates publicly available trial information.