NCT00440492已完成1 期
An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer9 个研究点 分布在 2 个国家开始时间: 2006年12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
- 9
- 主要终点
- To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
研究概览
简要总结
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
- •RA disease onset after 16 years of age and has had the disease for at least 6 months
- •Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months
排除标准
- •Evidence of unstable clinically significant disease
结局指标
主要结局
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
次要结局
未报告次要终点
研究者
研究点 (9)
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