NCT02100917已完成1 期
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
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
- 70
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male adults
- •Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]²
- •The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.
排除标准
- •History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
- •Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
- •History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
- •History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia
研究组 & 干预措施
DMB-3111
Experimental
6 mg/kg is once given in intravenous drip infusion taking 90 min
干预措施: DMB-3111 (Drug)
trastuzumab
Active Comparator
6 mg/kg is once given in intravenous drip infusion taking 90 min
干预措施: trastuzumab (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Day1-71
Area Under the Concentration-Time (AUC)
时间窗: Day1-71
次要结局
- Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration(Day1-71)
- Mean residence time (MRT) from 0 to infinity(Day1-71)
- Area under the concentration-time curve (AUC) from 0 to infinity(Day1-71)
- Time to reach the peak concentration (tmax)(Day1-71)
- Mean residence time (MRT) from 0 to final sampling time point(Day1-71)
- elimination rate constant (kel)(Day1-71)
- Incidence of adverse events(Day1-71)
- Elimination half life (t1/2)(Day1-71)
- Clearance (CL)(Day1-71)
研究者
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