NCT01042314已完成1 期
A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2010年1月最近更新:
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
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
研究概览
简要总结
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men and postmenopausal women
排除标准
- •Medical History and Concurrent Diseases
- •Gastrointestinal disease
- •Gastrointestinal bleeding disorders
- •History of peptic ulcer disease
- •History of cholecystectomy
- •History of seizure disorder
- •History of asthma
- •History of Chronic Obstructive Pulmonary Disease
- •History of cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
- •Inability to tolerate oral medication
- •Inability to be venipunctured and/or tolerate venous access
研究组 & 干预措施
Donepezil and BMS-708163
Experimental
干预措施: Donepezil (Drug)
Donepezil and BMS-708163
Experimental
干预措施: BMS-708163 (Drug)
结局指标
主要结局
Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
时间窗: Days 14 and 28
次要结局
- Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs(Days 7, 14, 21, 29 and study discharge)
研究者
研究点 (1)
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