NCT03802526已完成1 期
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年4月3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
- 37
- 试验地点
- 1
- 主要终点
- Pharmacokinetic interaction
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
详细描述
pharmacokinetics and safety/tolerability between NVP-1805-R1 and 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged 19-45 years.
- •BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
- •Voluntarily provided a witten consent to participate in this clinical study.
排除标准
- •Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- •History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- •Pregnant or lactating women.
研究组 & 干预措施
NVP-1805-R1
Experimental
Drug: NVP-1805-R1
1 tablet, oral dosing
干预措施: NVP-1805-R1 (Drug)
NVP-1805-R2
Experimental
Drug: NVP-1805-R2
1 tablet, oral dosing
干预措施: NVP-1805-R2 (Drug)
NVP-1805-R1 and NVP-1805-R2
Experimental
Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)
干预措施: NVP-1805-R1 and NVP-1805-R2 (Drug)
结局指标
主要结局
Pharmacokinetic interaction
时间窗: 0hours - 48hours
Area under the curve (AUC)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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