Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
研究概览
简要总结
Pharmacokinetics (PK) study
详细描述
To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).
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 >18 years of age with diagnosed Rheumatoid Arthritis(RA).
排除标准
- •Chronic or acute renal disease
- •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
10mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
干预措施: Methotrexate (MTX) (Drug)
15mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
干预措施: Methotrexate (MTX) (Drug)
20mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
干预措施: Methotrexate (MTX) (Drug)
25mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
干预措施: Methotrexate (MTX) (Drug)
结局指标
主要结局
Bioequivalence Based Upon 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
Bioequivalence Based Upon 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 post-dose (AUC\[0-24\]/Dose) for each treatment
Bioequivalence Based Upon Dose-Normalized Cmax for MTX
时间窗: 24 Hour period
Dose-normalized maximum observed concentration for each treatment
次要结局
未报告次要终点