NCT05812417已完成1 期
An Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010
研究概览
简要总结
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •[Healthy Volunteer]
- •Adult male or female, 19 years to 75 years
- •eGFR ≥ 90 mL/min/1.73m^2
- •Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0 kg/m^2
- •The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
- •The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire
- •[Renal Impairment Patient]
- •Adult male of female, 19 years to 75 years
- •eGFR < 90 mL/min/1.73m^2, not on dialysis
- •Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0kg/m^2
- •The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
- •The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire
排除标准
- •The subjects with acute illness
- •The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
- •The subjects hypersensitive to any of the Investigational Product components or other drug components
- •The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
- •The subjects who have history of drug abuse
- •The subjects who are pregnant or lactating
- •The subjects who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the Investigational Product until the 4 weeks after the last administration
研究组 & 干预措施
Normal renal function
Active Comparator
eGFR >=90 mL/min/1.73m^2
干预措施: DA-8010 (Drug)
Mild renal impairment
Experimental
eGFR 60~89 mL/min/1.73m^2
干预措施: DA-8010 (Drug)
Moderate renal impairment
Experimental
eGFR 30~59 mL/min/1.73m^2
干预措施: DA-8010 (Drug)
Severe renal impairment
Experimental
eGFR 15~29 mL/min/1.73m^2
干预措施: DA-8010 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010
时间窗: Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1
Peak Plasma Concentration (Cmax) of DA-8010
时间窗: Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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