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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline, Standard Deviation of Lateral Position
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •equal to or greater than 18 years old
- •equal to or less than 65 years old
- •weight at least 120 pounds
- •medically healthy
- •able to eat a high fat meal
排除标准
- •medications known to affect sleep-wake cycle
- •current use of cimetidine
- •current use of certain anti-depressants
- •current use of certain antibiotics
- •positive urine drug test for mind altering medications
研究组 & 干预措施
m640 mg
metaxalone micronized 640 mg tablet, single dose
干预措施: metaxalone m640 mg (Drug)
m640 mg
metaxalone micronized 640 mg tablet, single dose
干预措施: tizanidine 8mg (Drug)
tizanidine 8 mg
tizanidine 8 mg tablet, single dose
干预措施: metaxalone m640 mg (Drug)
tizanidine 8 mg
tizanidine 8 mg tablet, single dose
干预措施: tizanidine 8mg (Drug)
结局指标
主要结局
Change from baseline, Standard Deviation of Lateral Position
时间窗: Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8)
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
时间窗: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Creyos Cognitive Test
Change From Baseline, Standard Deviation of Lateral Position, no Traffic
时间窗: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic
时间窗: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic Plus Lead Vehicle
时间窗: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
次要结局
- The number of product related adverse events experienced by participants from Visit 1 through Visit 4(Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15))
- Change from baseline of participants' subjective report of drowsiness on a 10-point scale(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)(Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8))