A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 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 evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.
详细描述
This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •Healthy males
- •No history of clinically significant medical disorder
- •Capable of consent to participate in the study
排除标准
- •History of hypersensitive reactions to study drug or other related drugs
- •Any significant abnormality found during screening
- •Any significant medical history
- •History of alcohol abuse, smoking continuously
- •History of drug abuse
- •Clinically significant surgery within 4 weeks prior to administration of the study drug
- •Participation in another clinical trial within 3 months prior to administration of the study drug
研究组 & 干预措施
NVP-1402
NVP-1402 was administered once a day for 24 hours
干预措施: NVP-1402 (Drug)
NVP-1402R
Active comparator was administered twice a day for 24 hours
干预措施: NVP-1402R (Drug)
结局指标
主要结局
Pharmacokinetics of plasma: Cmax
时间窗: up to 24 hours after administration
Maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: AUClast
时间窗: up to 24 hours after administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
次要结局
- Pharmacokinetics of plasma: AUCinf(up to 24 hours after administration)
- Pharmacokinetics of plasma: Tmax(up to 24 hours after administration)
- Pharmacokinetics of plasma: t1/2(up to 24 hours after administration)