NCT00692146已完成1 期
A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy 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
- 36
- 主要终点
- VAS, HPT
研究概览
简要总结
A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
- •Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
- •Non-fertile females
排除标准
- •History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
- •History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
研究组 & 干预措施
1
Experimental
36 subjects receiving a specified volume of the active component AZD1386 in a single dose.
干预措施: AZD1386 (Drug)
2
Placebo Comparator
36 subjects receiving a specified volume of placebo in a single dose.
干预措施: Placebo (Drug)
结局指标
主要结局
VAS, HPT
时间窗: Visit 2-4
次要结局
- eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia(Visit 2-4)
- Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3(Visit 1-5)
- Pharmacokinetics/Pharmacodynamics(Visit 2-4)
研究者
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