NCT06088017已完成1 期
A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391(2) and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cmax of CKD-391(2)
研究概览
简要总结
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391(2)
详细描述
A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391(2) and co-administration of CKD-331 and D337 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 1
Experimental
- Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-391(2) (Drug)
Sequence 1
Experimental
- Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-331, D337 (Drug)
Sequence 2
Experimental
- Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
干预措施: CKD-391(2) (Drug)
Sequence 2
Experimental
- Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
- Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
- Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
干预措施: CKD-331, D337 (Drug)
结局指标
主要结局
Cmax of CKD-391(2)
时间窗: Pre-dose(0 hour) to 72hours
Maximum plasma concentration of the drug
AUCt of CKD-391(2)
时间窗: Pre-dose(0 hour) to 72hours
Area under the concentration-time curve time zero to time
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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