NCT00713765终止1 期
A Double-blind, Randomised, Cross-over, Placebo-controlled Study of Repeated Oral Doses of AZD3480 and a Single Dose of Donepezil to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Donepezil in Healthy Extensive and Poor Metabolisers of CYP2D6
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study-specific procedures
- •BMI between 18 and 30 kg/m2
- •Medical and surgical history and physical examination without any clinically significant findings
- •Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles
排除标准
- •History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- •Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product
- •Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
研究组 & 干预措施
A
Experimental
AZD3480 + Donepezil
干预措施: AZD3480 (Drug)
A
Experimental
AZD3480 + Donepezil
干预措施: Donepezil (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
研究点 (1)
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