NCT07532148尚未招募1 期
A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- AUCtau
研究概览
简要总结
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215
详细描述
A Multi-center, Randomized, Open-Label, Multiple-dose, Two-Stage, Two-treatment, Two-period, Crossover Study
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- •18.0kg/m2≤body mass index(BMI)≤28.0kg/m2
排除标准
- •Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- •Patients with central nervous system metastases, unless clinically stable after treatment
- •CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
- •Subjects who are unable to participate in this clinical trial at the discretion of the investigator
研究组 & 干预措施
Experimental group 2
Experimental
Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)
干预措施: CKD-215 (Drug)
Experimental group 2
Experimental
Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)
干预措施: D215 (Drug)
Experimental group 1
Experimental
Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)
干预措施: CKD-215 (Drug)
Experimental group 1
Experimental
Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)
干预措施: D215 (Drug)
结局指标
主要结局
AUCtau
时间窗: 0~12 hours
Area under the plasma concentration-time curve over the dosing interval at steady state
Css,max
时间窗: 0~12 hours
Maximum observed plasma concentration at steady state
次要结局
未报告次要终点
研究者
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