Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Pharmacokinetics : Cmax
研究概览
简要总结
The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203
详细描述
This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects
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 adult subjects who signed informed consent
排除标准
- •Subjects has a history of allergy reaction of study drug ingredient
- •Subjects participated in another clinical trial within 3 months prior to administration of the study drug
- •Inadequate subject for the clinical trial by the investigator's decision
研究组 & 干预措施
NVP-1203(fed then fasting)
Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2
干预措施: NVP-1203 (Drug)
NVP-1203(fasting then fed)
Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2
干预措施: NVP-1203 (Drug)
结局指标
主要结局
Pharmacokinetics : Cmax
时间窗: 0-24 hours
Maximum plasma concentration
Pharmacokinetics : AUCt
时间窗: 0-24 hours
Area under the concentration-time curve
次要结局
- Pharmacokinetics : AUCinf(0-24 hours)
- Pharmacokinetics : t1/2(0-24 hours)
- Pharmacokinetics : Tmax(0-24 hours)