NCT00919607已完成1 期
Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
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
- 31
- 试验地点
- 1
- 主要终点
- single dose PK parameters(300mg)
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 through 60 years inclusive
- •Schizophrenia diagnosis
- •Body Mass Index (BMI) 20-27 kg/m2 (inclusive)
- •Provision of written informed consent before initiation of any study
排除标准
- •AIDS & hepatitis B
- •History of seizure disorder
- •History of episodic,idiopathic orthostatic hypotension
研究组 & 干预措施
1
Active Comparator
quetiapine fumarate extended-release 300mg,administered once-daily Day1~5
干预措施: quetiapine fumarate extended-release (Drug)
2
Experimental
quetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily
干预措施: quetiapine fumarate extended-release (Drug)
3
Experimental
quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily
干预措施: quetiapine fumarate extended-release (Drug)
结局指标
主要结局
single dose PK parameters(300mg)
时间窗: Day1 to 48 hour after Day 5
Steady-state multiple doses PK parameters
时间窗: Day 1 to 48 hours after Day7
次要结局
- Clinical significant change in Lab test(baseline up to Day 9)
- Incidence and severity of AEs(sign ICF to Day 9)
- Clinical significant change in vital signs(baseline up to Day 9)
研究者
研究点 (1)
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