NCT01795716已完成1 期
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
研究概览
简要总结
- purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG).
- Experimental Design： Two-period crossover design
- Test drug: imatinib mesylate capsule Reference drug: Glivec
- Sample size：20
详细描述
To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic myeloid leukemia;
- •Age: 18-65 years,gender:both.
- •Weight: standard weight ± 20% within, and avoid weight disparity is too large;
- •No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
- •Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
- •No other malignancy;
- •Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
- •Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.
排除标准
- •Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
- •Pregnant or lactating women and be sensitive to drug;
- •Subjects are thought unsuitable for the study by investigators;
- •Inability to comply with protocol or study procedures in the opinion of the investigator;
- •Attending other clinical trials or attended other clinical trials 3 months ago.
研究组 & 干预措施
mesylate imatinib capsule
Experimental
Single and multiple oral mesylate imatinib capsule 400mg qd
干预措施: mesylate imatinib capsule (Drug)
Glivec
Active Comparator
Single and multiple oral Glivec 400mg qd
干预措施: Glivec (Drug)
结局指标
主要结局
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
时间窗: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
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