Healthy Person Eats, Takes 1 Dose, Tested for Drowsiness, Fall Risk, Then Takes Second Dose Followed by Same Tests

ConditionHealthy Participants

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-55

SponsorPrimus Pharmaceuticals

About this trial

Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 18 to 55 years old

Weigh at least 120 pounds

Medically healthy

Able to sign and date informed consent form

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Active metaxalone m640 mgActive comparator 1 intervention

Group B: Active metaxalone 800 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)

Measures the time between a visual stimulus and response, measured in milliseconds

Time frame

Baseline dose to four (4 ) hours post-dose

Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT)

measures the time between a visual stimulus and response, measured in milliseconds

Time frame

Baseline dose to approximately 4 hours post-dose

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Primus Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: