NCT01039194已完成1 期
A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine 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
- Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
研究概览
简要总结
The purpose of the study is to find out if the plasma concentration of galantamine extended release 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
- •Gastrointestinal disorders
- •Bleeding disorders
- •Peptic ulcer disease
- •Cholecystectomy
- •Seizure disorder
- •Chronic obstructive pulmonary disease
- •Urinary tract obstruction
- •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
galantamine 8 mg (ER)
Active Comparator
干预措施: galantamine (Drug)
galantamine 16 mg (ER)
Active Comparator
干预措施: galantamine (Drug)
BMS-708163
Active Comparator
干预措施: BMS-708163 (Drug)
结局指标
主要结局
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
时间窗: Study Days 14 & 24
次要结局
- Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)(Study Days 7, 14, 18, 25 and study discharge)
研究者
研究点 (1)
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