NCT07521241尚未招募1 期
A Randomized, Open-label, Two-treatment, Two-period, Two-sequence Crossover Clinical Trial to Evaluate the Pharmacokinetics and Safety of AD-230 in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of AD-230 in Healthy Adults
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- •Subjects aged 19 years or older and under 65 years at the screening visit
排除标准
- •Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- •Other exclusions applied
研究组 & 干预措施
Sequence A
Experimental
Period 1 : Reference drug(AD-2301), Period 2 : Test drug(AD-230) Single oral dose administration of AD-2301 three times in Period 1, followed by single oral dose administration of AD-230 twice in Period 2.
干预措施: AD-230, AD-2301 (Drug)
Sequence B
Experimental
Period 1 : Test drug(AD-230), Period 2 : Reference drug(AD-2301) Single oral dose administration of AD-230 twice in Period 1, followed by single oral dose administration of AD-2301 three times in Period 2
干预措施: AD-230, AD-2301 (Drug)
结局指标
主要结局
AUClast
时间窗: -24hr to 72hr
Cmax
时间窗: -24hr to 72hr
AUClast
时间窗: -24hours to 72hours
Cmax
时间窗: -24hours to 72hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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