NCT00832221已完成1 期
An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers
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
- AstraZeneca
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Positron emission tomography using the radioligand [11C]raclopride
研究概览
简要总结
The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal MRI scan
- •Body mass index 19-30 kg/m2 and weight of 50-100 kg
- •Clinically normal physical findings, medical history and laboratory values
排除标准
- •Trauma or sickness last 2 weeks before the first PET examination.
- •A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
- •Any previous participation in a PET study
- •Subjects suffer from claustrophobia
研究组 & 干预措施
1
Active Comparator
干预措施: SEROQUEL XR (quetiapine) (Drug)
1
Active Comparator
干预措施: radioligand [11C]raclopride (Drug)
2
Active Comparator
干预措施: SEROQUEL IR (quetiapine) (Drug)
2
Active Comparator
干预措施: radioligand [11C]raclopride (Drug)
结局指标
主要结局
Positron emission tomography using the radioligand [11C]raclopride
时间窗: 5 visits
次要结局
- Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.(5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.)
- Pharmacokinetics of quetiapine and its main active metabolite(22 samples)
研究者
研究点 (1)
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