A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics Following Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants: A Bootstrap Validation.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 55 years old
- •Weigh at least 120 pounds
- •Medically healthy
- •Able to sign and date informed consent form
排除标准
- •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
- •Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia
- •Having difficulty eating high fat meal
- •Participants who are pregnant, nursing or intending to become pregnant during the period of study.
- •Blood Pressure > 160/110 or <90/50 mmHg.
- •Heart Rate >100 or < 50/ beats per minute.
- •Having a history of seizure disorder or epilepsy.
研究组 & 干预措施
Active metaxalone m640 mg
One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)
干预措施: Metaxalone 640 mg (Drug)
Active metaxalone 800 mg
One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)
干预措施: Metaxalone 800 MG (Drug)
结局指标
主要结局
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)
时间窗: 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)
时间窗: Baseline dose to approximately 4 hours post-dose
次要结局
未报告次要终点