NCT05023031已完成1 期
A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年10月5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
- 53
- 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-2102 and NVP-2102-R.
详细描述
Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-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-2102
Experimental
NVP-2102
干预措施: NVP-2102 (Drug)
NVP-2102-R
Active Comparator
NVP-2102-R
干预措施: NVP-2102-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 ~ 72 hours
Pharmacokinetics parameter derived from plasma
Evaluation of Maximum observed plasma concentration(Cmax)
时间窗: 0 ~ 72 hours
Pharmacokinetics parameter derived from plasma
次要结局
- Evaluation of Terminal phase of Half-life(t1/2)(0 ~ 72 hours)
- Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)(0 ~ 72 hours)
- Evaluation of Time of peak concentration(Tmax)(0 ~ 72 hours)
- Evaluation of AUCt/AUC∞(0 ~ 72 hours)
- Evaluation of total clearance of the drug from plasma after oral administration(CL/F)(0 ~ 72 hours)
- Evaluation of volume of distribution after non-intravenous administration(Vz/F)(0 ~ 72 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2HealthyNCT04181437NVP Healthcare40
已完成
1 期
Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy SubjectsHealthy SubjectsNCT05141110NVP Healthcare50
已完成
1 期
A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402HealthyNCT02897726NVP Healthcare38
已完成
1 期
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT01013142MediciNova48
已完成
1 期
Pharmacokinetics of PN-232 in Healthy VolunteersHealthy SubjectsNCT04819620Protagonist Therapeutics, Inc.48