Population Pharmacokinetics of Imatinib in CML Patients in Iran
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Percent of changes of AUC, trough Concentration from predicted values
研究概览
简要总结
The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.
详细描述
patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient in chronic phase of myeloid leukemia
- •no liver and renal failure
排除标准
- •multiple dug treatment
- •previous treatment of interferon
- •patients in blast or accelerated phase
研究组 & 干预措施
Imatinib, CML
Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study
干预措施: Imatinib (Drug)
结局指标
主要结局
Percent of changes of AUC, trough Concentration from predicted values
时间窗: Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose
The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd.
次要结局
未报告次要终点
研究者
Ehsan Mohajeri
Assistant of Pharmaceutics
Kerman University of Medical Sciences