NCT05862090已完成1 期
An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月5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
- 40
- 试验地点
- 1
- 主要终点
- AUCtau
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19~54 years in healthy volunteers
- •18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- •90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- •Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
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
Arm 1 (First RLD2301, then RLD2301+RLD2007)
Experimental
Period1 : RLD2301 Period2 : RLD2301 + RLD2007
干预措施: RLD2301 (Drug)
Arm 1 (First RLD2301, then RLD2301+RLD2007)
Experimental
Period1 : RLD2301 Period2 : RLD2301 + RLD2007
干预措施: RLD2007 (Drug)
Arm 2 (First RLD2007, then RLD2301+RLD2007)
Experimental
Period1 : RLD2007 Period2 : RLD2301 + RLD2007
干预措施: RLD2301 (Drug)
Arm 2 (First RLD2007, then RLD2301+RLD2007)
Experimental
Period1 : RLD2007 Period2 : RLD2301 + RLD2007
干预措施: RLD2007 (Drug)
结局指标
主要结局
AUCtau
时间窗: 0~24 hours after final dose administration
Pharmacokinetic evaluation
Css,max
时间窗: 0~24 hours after final dose administration
Pharmacokinetic evaluation
次要结局
- Css,min(0~24 hours after final dose administration)
- t1/2(0~24 hours after final dose administration)
- Fluctuation[(Css,max-Css,min)/Css,av](0~24 hours after final dose administration)
- Css,av(0~24 hours after final dose administration)
- Swing[(Css,max-Css,min)/Css,min](0~24 hours after final dose administration)
- Tss,max(0~24 hours after final dose administration)
- CLss/F(0~24 hours after final dose administration)
- Vdss/F(0~24 hours after final dose administration)
研究者
研究点 (1)
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