NCT00688402已完成1 期
A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
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
- 48
- 试验地点
- 1
- 主要终点
- Specific AE questions
研究概览
简要总结
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Female subjects with no childbearing potentials or using highly efficient contraceptive methods
- •Clinically normal physical findings
排除标准
- •Clinically significant illness within 2 weeks prior to the first dose of investigational product
- •History of clinically significant disease
- •Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
研究组 & 干预措施
1
Experimental
IR Formulation 65 mg
干预措施: AZD3355 (Drug)
2
Experimental
IR Formulation 150 mg
干预措施: AZD3355 (Drug)
3
Experimental
MR formulation, 1h 65 mg
干预措施: AZD3355 (Drug)
4
Experimental
MR Formulation, 1h 150 mg
干预措施: AZD3355 (Drug)
5
Experimental
MR Formulation, 2h 150 mg
干预措施: AZD3355 (Drug)
结局指标
主要结局
Specific AE questions
时间窗: During 0-4 hours post dose
次要结局
- PK variables(Frequent sampling up to 36 hours post dose)
- Safety variables (other adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
研究点 (1)
Loading locations...
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