A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under Curve last(AUCt)
研究概览
简要总结
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
详细描述
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II. Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
- Period 1: Reference drug
- Period 2: Test drug 1
- Period 3: Test drug 2
干预措施: Test drug 2 (Drug)
Group 2
- Period 1: Test drug 2
- Period 2: Reference drug
- Period 3: Test drug 1
干预措施: Reference drug (Drug)
Group 1
- Period 1: Reference drug
- Period 2: Test drug 1
- Period 3: Test drug 2
干预措施: Reference drug (Drug)
Group 1
- Period 1: Reference drug
- Period 2: Test drug 1
- Period 3: Test drug 2
干预措施: Test drug 1 (Drug)
Group 2
- Period 1: Test drug 2
- Period 2: Reference drug
- Period 3: Test drug 1
干预措施: Test drug 1 (Drug)
Group 2
- Period 1: Test drug 2
- Period 2: Reference drug
- Period 3: Test drug 1
干预措施: Test drug 2 (Drug)
Group 3
- Period 1: Test drug 1
- Period 2: Test drug 2
- Period 3: Reference drug
干预措施: Reference drug (Drug)
Group 3
- Period 1: Test drug 1
- Period 2: Test drug 2
- Period 3: Reference drug
干预措施: Test drug 1 (Drug)
Group 3
- Period 1: Test drug 1
- Period 2: Test drug 2
- Period 3: Reference drug
干预措施: Test drug 2 (Drug)
Group 4
- Period 1: Test drug 2
- Period 2: Test drug 1
- Period 3: Reference drug
干预措施: Reference drug (Drug)
Group 4
- Period 1: Test drug 2
- Period 2: Test drug 1
- Period 3: Reference drug
干预措施: Test drug 1 (Drug)
Group 4
- Period 1: Test drug 2
- Period 2: Test drug 1
- Period 3: Reference drug
干预措施: Test drug 2 (Drug)
Group 5
- Period 1: Test drug 1
- Period 2: Reference drug
- Period 3: Test drug 2
干预措施: Reference drug (Drug)
Group 5
- Period 1: Test drug 1
- Period 2: Reference drug
- Period 3: Test drug 2
干预措施: Test drug 1 (Drug)
Group 5
- Period 1: Test drug 1
- Period 2: Reference drug
- Period 3: Test drug 2
干预措施: Test drug 2 (Drug)
Group 6
- Period 1: Reference drug
- Period 2: Test drug 2
- Period 3: Test drug 1
干预措施: Reference drug (Drug)
Group 6
- Period 1: Reference drug
- Period 2: Test drug 2
- Period 3: Test drug 1
干预措施: Test drug 1 (Drug)
Group 6
- Period 1: Reference drug
- Period 2: Test drug 2
- Period 3: Test drug 1
干预措施: Test drug 2 (Drug)
结局指标
主要结局
Area Under Curve last(AUCt)
时间窗: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.
Cmax
时间窗: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.
次要结局
未报告次要终点