Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Dose-Normalized AUC[0-Inf] for MTX
研究概览
简要总结
Relative Bioavailability Comparison study
详细描述
A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis
排除标准
- •Pregnant females
- •Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
研究组 & 干预措施
10 mg Methotrexate (MTX)
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
干预措施: MTX (Drug)
15 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
干预措施: MTX (Drug)
20 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
干预措施: MTX (Drug)
25 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
干预措施: MTX (Drug)
结局指标
主要结局
Dose-Normalized AUC[0-Inf] for MTX
时间窗: 24 Hour period
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Dose-Normalized AUC[0-24] for MTX
时间窗: 24 Hour period
Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment
Dose-Normalized Cmax for MTX
时间窗: 24 Hour period
Dose-normalized maximum observed concentration (Cmax) for each treatment
次要结局
未报告次要终点