The Food Effect on the Pharmacokinetics of NVP-1402
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 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 the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.
详细描述
This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.
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-1402-1
NVP-1402 was administered once a day for 24 hours
干预措施: NVP-1402 (Drug)
NVP-1402-2
NVP-1402 was administered once a day for 24 hours
干预措施: NVP-1402 (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)