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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
A single dose of micronize metaxalone 640 mg
A single dose of tizanidine 8 mg
Sun Valley Arthritis Center
Peoria, Arizona, United States
Change from baseline, Standard Deviation of Lateral Position
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Time frame: Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8)
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
Creyos Cognitive Test
Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Change from baseline of participants' subjective report of drowsiness on a 10-point scale
Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake
Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)
Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.
Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
The number of product related adverse events experienced by participants from Visit 1 through Visit 4
Adverse and Serious Adverse Events
Time frame: Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15)
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