NCT07229560已完成1 期
The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年11月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Maximum concentration (Cmax) of HRS-8080.
研究概览
简要总结
This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-55 years;
- •Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
- •Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
- •Take contraception.
排除标准
- •Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
- •Severe infection, severe trauma or major surgery;
- •Any medications in the two weeks before screening or baseline period;
- •History of blood donation or severe blood loss;
- •Have been vaccinated within 3 months before the screening or baseline period;
- •History of smoking or excessive alcohol or drug abuse;
- •History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
- •Other situations in which the researcher judges unsuitable.
研究组 & 干预措施
HRS-8080 Tablets and Itraconazole Capsules Group
Experimental
干预措施: HRS-8080 Tablet (Drug)
HRS-8080 Tablets and Itraconazole Capsules Group
Experimental
干预措施: Itraconazole Capsule (Drug)
结局指标
主要结局
Maximum concentration (Cmax) of HRS-8080.
时间窗: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.
时间窗: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
时间窗: From Day 1 to Day 11.
次要结局
- Terminal elimination half-life (t1/2) of HRS-8080.(From Day 1 to Day 11.)
- Apparent volume of distribution (Vz/F) of HRS-8080.(From Day 1 to Day 11.)
- Clearance (CL/F) of HRS-8080.(From Day 1 to Day 11.)
- Adverse events (AEs).(From Day 1 to Day 17.)
- Time to maximum plasma concentration (Tmax) of HRS-8080.(From Day 1 to Day 11.)
- Serious adverse events (SAEs).(From Day 1 to Day 17.)
研究者
研究点 (2)
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