NCT01324336已完成不适用
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of 6-MP
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.
排除标准
- •Inability to have blood drawn for the screening lab tests
- •Received methotrexate or folate supplement within the last 24 hours
- •Pregnant or lactating females
- •Inability to swallow a pill
- •Hemoglobin less or equal to 8 gm/dl
- •Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator
- •Weight < or = 16 kg
研究组 & 干预措施
4-17 years, receiving 6-MP
干预措施: 6-Mercaptopurine (Drug)
结局指标
主要结局
Pharmacokinetics of 6-MP
时间窗: 8 hours post administration
To compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
次要结局
未报告次要终点
研究者
研究点 (1)
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