NCT00581243终止1 期
An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 32 人开始时间: 2008年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 主要终点
- Observe safety and tolerability
研究概览
简要总结
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, aged 18-50 years old
- •Women, aged 18-50 years old
排除标准
- •Non-lactating women, aged 18-50 years old
- •Non-pregnant women, aged 18-50 years old
研究组 & 干预措施
3
Experimental
10 mg SLV-313 SR (fixed dose)
干预措施: SLV-313 SR (Drug)
4
Experimental
xx mg SLV-313 SR (titration)
干预措施: SLV-313 SR (Drug)
1
Experimental
2 mg SLV-313 SR (fixed dose)
干预措施: SLV-313 SR (Drug)
2
Experimental
5 mg SLV-313 SR (fixed dose)
干预措施: SLV-313 SR (Drug)
结局指标
主要结局
Observe safety and tolerability
时间窗: 25 days
次要结局
- PK and PD profile(25 days)
研究者
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