NCT05012436已完成1 期
A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Yuhan Corporation2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年7月24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
- 16
- 试验地点
- 2
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •19~75 years old, healthy volunteers and renal impairments
- •eGFR >= 60mL/min/1.73m2
- •60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2
- •written informed consent
排除标准
- •AST or ALT > 1.5 * Upper normal range
- •Total bilirubin > 1.5 * Upper normal range
- •Blood CPK > 1.5 * Upper normal range
- •Total Cholesterol >1.5 * Upper normal range
- •Woman who is pregnant or lactating
- •Patients who are difficult to participate in cinical trials judged by Investigators
- •have participated in other clinical trials within 180 days before IP intake
研究组 & 干预措施
YHD1119 75mg, 150mg NF
Experimental
CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF
干预措施: YHD1119 75mg (Drug)
YHD1119 75mg
Experimental
60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA
干预措施: YHD1119 75mg (Drug)
结局指标
主要结局
AUClast
时间窗: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Cmax
时间窗: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
次要结局
- CL/F(0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour)
- t1/2(0,1,2,3,4,5,6,8,10,12,14,24,48,72hour)
- Tmax(0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour)
- V/F(0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour)
- AUCinf(0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour)
研究者
研究点 (2)
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