A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- YHD1119 AUC last
研究概览
简要总结
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.
详细描述
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8.
Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
研究组 & 干预措施
Group1
taking YHD1119 (pregabalin 300mg) in fasted state at Period 1
干预措施: YHD1119 300mg (Drug)
Group2
taking YHD1119 (pregabalin 300mg) in fed state at Period 1
干预措施: YHD1119 300mg (Drug)
结局指标
主要结局
YHD1119 AUC last
时间窗: 0 - 36hrs
AUC last
YHD1119 Cmax
时间窗: 0 - 36hrs
Cmax
次要结局
未报告次要终点