NCT03220399撤回1 期
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
NVP Healthcare0 个研究点开始时间: 2019年12月1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
- 撤回
- 发起方
- 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-1603-1 and NVP-1603-2
详细描述
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Men 19years of age or older at screening test.
- •BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
- •Subject has signed and dated informed consent.
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
- •Current alcohol abuse.
研究组 & 干预措施
NVP-1603-1 (P)
Experimental
Drug: NVP-1603-1
1capsule, oral dosing
干预措施: NVP-1603-1 (P) (Drug)
NVP-1603-2(T)
Experimental
Drug: NVP-1603-2
1Tablet, oral dosing
干预措施: NVP-1603-2 (T) (Drug)
NVP-1603-1and NVP-1603-2 (P+T)
Experimental
Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)
干预措施: NVP-1603-1 and NVP-1603-2 (P+T) (Drug)
结局指标
主要结局
Pharmacokinetic interaction
时间窗: 0h - 48hrs
Area under the curve (AUC)
次要结局
未报告次要终点
研究者
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