NCT00990613已完成1 期
A Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data
研究概览
简要总结
To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian, male or females, 50 to 85 years inclusive.
- •Subjects must have adequate space available on each side of the upper or middle back that is free from excessive hair, broken or irritated skin, tattoos, scars, moles, acne, and sunburn.
排除标准
- •Evidence or history of any major medical or psychiatric illness or unstable medical condition within six months of Screening that may increase the risk associated with study participation.
- •Subjects with any central nervous system disease including Alzheimer's disease, Parkinson's disease, Huntington disease, or any form of dementia.
- •Subjects with any history of stroke, known cerebrovascular disease or subjects with any history of structural brain disease.
- •Any history of epilepsy, seizure disorder (i.e., including febrile seizures) or convulsion.
- •Subjects with any skin disorders that might prevent application of the dimebon solution including, but not limited to, any known sensitivity to adhesives.
研究组 & 干预措施
Cohort 1
Other
干预措施: Dimebon IR (Drug)
Cohort 1
Other
干预措施: Dimebon Transdermal (Drug)
Cohort 2
Other
干预措施: Dimebon IR (Drug)
Cohort 2
Other
干预措施: Dimebon Transdermal (Drug)
结局指标
主要结局
Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data
时间窗: 4 to 6 days
次要结局
- Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs.(4 to 6 days)
研究者
研究点 (1)
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