NCT00448032已完成1 期
A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Men, aged 20 to 45 years, inclusive
- •Body mass index in the range of 17.6 to 26.4 kg/m2
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
排除标准
- •History of cardiac, thyroid, muscle, and kidney abnormalities
- •History of NSAID induced bronchospasm or asthma
- •History of any clinically important allergies
结局指标
主要结局
Safety
次要结局
- Pharmacokinetics/Pharmacodynamics
研究者
研究点 (1)
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