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| Name | Class |
|---|---|
| Sun Valley Arthritis Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metaxalone m640 mg | Active Comparator | metaxalone micronized 640 mg tablet, single dose at Visit 2 or Visit 3 |
|
| tizanidine 8 mg | Active Comparator | tizanidine 8 mg tablet, single dose at Visit 2 or Visit 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metaxalone m640 | Drug | A single dose of micronize metaxalone 640 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline, Standard Deviation of Lateral Position | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software | 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 | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J C Lukban, DO | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Valley Arthritis Center | Peoria | Arizona | 85381 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C023754 | tizanidine |
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This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.
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| tizanidine | Drug | A single dose of tizanidine 8 mg |
|
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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. |
| 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 | Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15) |