NCT01207973终止1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of Multiple Rising Oral Doses (50, 100, 200 and 350 mg qd and 100 mg Bid for 12 Days) of BI 113823 as Tablet in Male and Female Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety (Physical examination)
研究概览
简要总结
The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.
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
- Double
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 113823
Experimental
5 dose-groups of multiple oral doses of BI 113823
干预措施: BI 113823 (Drug)
结局指标
主要结局
Safety (Physical examination)
时间窗: 15 days
Safety (Vital signs)
时间窗: 15 days
Safety (12-lead ECG)
时间窗: 15 days
Safety (Adverse Events)
时间窗: 15 days
Tolerability (Assessment of tolerability by investigator)
时间窗: 15 days
Safety (Clinical laboratory tests)
时间窗: 15 days
次要结局
- Measures of pharmacodynamic effects(15 days)
- Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed(15 days)
研究者
研究点 (1)
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