NCT07784621尚未招募1 期
An Open-Label, Multiple-oral Dosing, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B 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
- 30
- 试验地点
- 1
- 主要终点
- AUCtau,ss
研究概览
简要总结
This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults
详细描述
This randomized, open-label, 2-arm, 2-period, multiple-dose, phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of HUC2A-752 following repeated oral administration of HUC2A-752-A and HUC2A-752-B in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Healthy adult volunteers
- •Individuals with a body weight between 50.0 kg and 90.0 kg and a BMI between 18.5 kg/m² and 29.9 kg/m²
排除标准
- •Individuals with a history or presence of clinically significant diseases of the following systems: hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular , musculoskeletal, urological, psychiatric, or sexual dysfunction.
- •Individuals with a history of gastrointestinal diseases or gastrointestinal surgeries that could affect the safety or pharmacokinetic evaluation of the investigational product.
- •Individuals with a history of hypersensitivity or clinically significant hypersensitivity reactions to losartan, pitavastatin, ezetimibe, angiotensin receptor blockers, statins, or any other medications.
研究组 & 干预措施
Pitavastatin/Ezetimibe
Experimental
HUC2A-752-B
干预措施: Pitavastatin plus Ezetemibe (Drug)
Losartan
Experimental
HUC2A-752-A
干预措施: Losartan (COZZAR®) (Drug)
结局指标
主要结局
AUCtau,ss
时间窗: Day 22
Area Under the Curve
Cmax,ss
时间窗: Day 22
Maximum concentration at steady state
Cmax,ss
时间窗: Day 15
Maximum concentration at steady state
AUCtau,ss
时间窗: Day 15
Area Under the Curve
次要结局
- Tmax,ss(Day 22)
- t1/2(Day 22)
- CLss/F(Day 22)
- Vdss/F(Day 22)
- Tmax,ss(Day 15)
- t1/2(Day 15)
- CLss/F(Day 15)
- Vdss/F(Day 15)
研究者
研究点 (1)
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