NCT04905342已完成1 期
An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年8月14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
- 58
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of plasma: Cmax
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
详细描述
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult subjects who signed informed consent
- •BMI of >18.0 kg/㎡ and <30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)
排除标准
- •Subjects participated in another clinical trial within 6 months prior to administration of the study drug
- •Inadequate subject for the clinical trial by the investigator's decision
- •Subjects participated in another clinical trial within 6 months prior to administration of the study drug
研究组 & 干预措施
NVP-1805
Experimental
NVP-1805 (80/10/20.8mg)
干预措施: NVP-1805 (Drug)
NVP-1805-R1 and NVP-1805-R2
Active Comparator
coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)
干预措施: NVP-1805-R1and NVP-1805-R2 (Drug)
结局指标
主要结局
Pharmacokinetics of plasma: Cmax
时间窗: 0hours - 72hours
period 1,2,3,4
Pharmacokinetics of plasma: AUClast
时间窗: 0hours - 72hours
period 1,2,3,4
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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