An Open-label, Fixed-sequence, 3-period Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUCτ
研究概览
简要总结
This study aims to evaluate the pharmacokinetic interactions between HUC2-744-A and HUC2-744-B following monotherapy or co-administration under multiple-dose conditions.
详细描述
For selected subjects, the designated investigational products are administered orally with 200 mL of water during Treatment 1 (HUC2-744-A), Treatment 2 (HUC2-744-B), and Treatment 3 (HUC2-744-A + HUC2-744-B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Healthy adults
- •Subjects with a body weight of 50 kg or more and a BMI within the range of 18.0 to 29.9 kg/m²
排除标准
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
- •Presence of acute disease symptoms within 28 days prior to the first dosing
- •History of any disease that may affect drug absorption, distribution, metabolism, or excretion
- •Hypersensitivity or history of clinically significant hypersensitivity to atorvastatin, telmisartan, drugs containing ingredients of the same class, or other medications (e.g., aspirin, antibiotics, dihydropyridine derivatives)
研究组 & 干预措施
single arm
IP are administered during Treatment 1 (Atorvastatin), Treatment 2 (Telmisartan), and Treatment 3 (Atorvastatin + Telmisartan)
干预措施: Atorvastatin Calcium (Drug)
single arm
IP are administered during Treatment 1 (Atorvastatin), Treatment 2 (Telmisartan), and Treatment 3 (Atorvastatin + Telmisartan)
干预措施: Telmisartan (Drug)
结局指标
主要结局
AUCτ
时间窗: Day 22
Area Under the Curve of telmisartan, atorvastatin
Cmax,ss
时间窗: Day 22
Maximum concentration at steady state of telmisartan, atorvastatin
次要结局
- Cmax,ss(Day 22)
- AUCτ(Day 22)