NCT05481307已完成1 期
An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年8月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Inhibition of Thromboxane B2(%)
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults in the age between 19 and 50 years old
- •Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
- •After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- •Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Fixed Sequence
Experimental
Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203
干预措施: RLD2202 (Drug)
Fixed Sequence
Experimental
Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203
干预措施: RLD2203 (Drug)
结局指标
主要结局
Inhibition of Thromboxane B2(%)
时间窗: 0~6 days
Pharmacodynamic evaluation
Cmax,ss of RLD2203
时间窗: 0~24 hours
Pharmacokinetic evaluation
Inhibition of Platelet Aggregation(%)
时间窗: 0~6 days
Pharmacodynamic evaluation
Cmax,ss of RLD2202
时间窗: 0~24 hours
Pharmacokinetic evaluation
AUCtau,ss of RLD2202
时间窗: 0~24 hours
Pharmacokinetic evaluation
AUCtau,ss of RLD2203
时间窗: 0~24 hours
Pharmacokinetic evaluation
次要结局
- Tmax,ss of RLD2202 and RLD2203(0~24 hours)
- CLss/F of RLD2202 and RLD2203(0~24 hours)
- t1/2,ss of RLD2202 and RLD2203(0~24 hours)
- Cmin,ss of RLD2202 and RLD2203(0~24 hours)
- Cavg,ss of RLD2202 and RLD2203(0~24 hours)
- Vdss/F of RLD2202 and RLD2203(0~24 hours)
- PTF of RLD2202 and RLD2203(0~24 hours)
研究者
研究点 (1)
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