Sun Valley Arthritis Center
Peoria, Arizona, 85381, United States
NCT Number: NCT06382662
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Peoria, Arizona, 85381, United States
Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.
The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.
Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.
The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of micronize metaxalone 640 mg
Other names: Metaxalone 640
A single dose of tizanidine 8 mg
Other names: Zanaflex
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Primus Pharmaceuticals
Industry
Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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