NCT05141110已完成1 期
A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月29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
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of Area under the plasma drug concentration-time curve(AUCt)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.
详细描述
Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R
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 subject, 19 years of age or older
- •Subjects who signed informed consent
- •Body mass index(BMI) of 18 to 30.0 kg/㎡
排除标准
- •Subject who has clinically significant medical history
- •Inadequate subject for the clinical trial by the investigator's decision
- •Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product
研究组 & 干预措施
NVP-1705
Experimental
Tablet formulation for oral administration, single dose of NVP-1705 at Day 1
干预措施: NVP-1705 (Drug)
NVP-1705-R
Active Comparator
Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1
干预措施: NVP-1705-R (Drug)
结局指标
主要结局
Evaluation of Area under the plasma drug concentration-time curve(AUCt)
时间窗: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
Evaluation of Maximum observed plasma concentration(Cmax)
时间窗: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
次要结局
- Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)(0 ~ 48 hours)
- Evaluation of AUCt/AUC∞(0 ~ 48 hours)
- Evaluation of Time of peak concentration(Tmax)(0 ~ 48 hours)
- Evaluation of Terminal phase of Half-life(t1/2)(0 ~ 48 hours)
研究者
研究点 (1)
Loading locations...
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