Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers who are ≥19 years and >65 years old
- •Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2
排除标准
- •Clinically significant Medical History
- •In the case of women, pregnant(Urine-HCG positive) or lactating women
研究组 & 干预措施
Sequence D
cross-over
干预措施: DW5124 (Drug)
Sequence D
cross-over
干预措施: DW5124-R (Drug)
Sequence E
cross-over
干预措施: DW5124 (Drug)
Sequence E
cross-over
干预措施: DW5124-R (Drug)
Sequence F
cross-over
干预措施: DW5124 (Drug)
Sequence F
cross-over
干预措施: DW5124-R (Drug)
Sequence B
cross-over
干预措施: DW5124 (Drug)
Sequence B
cross-over
干预措施: DW5124-R (Drug)
Sequence C
cross-over
干预措施: DW5124 (Drug)
Sequence C
cross-over
干预措施: DW5124-R (Drug)
Sequence A
cross-over
干预措施: DW5124 (Drug)
Sequence A
cross-over
干预措施: DW5124-R (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: up to 72 hour
Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 72 hour
Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed
次要结局
- Time to maximum plasma concentration (Tmax)(up to 72 hour)
- Terminal half life (t1/2)(up to 72 hour)
- Apparent clearance (CL/F)(up to 72 hour)
- Apparent volume of distribution (Vd/F)(up to 72 hour)