NCT07035665已完成1 期
A Single-Center, Randomized, Open-Label, Crossover Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Peak concentration (Cmax) of HRS-5965
研究概览
简要总结
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed the informed consent form pre-trial.
- •Aged 18-45 years at signing the informed consent form.
- •Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.
排除标准
- •Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever > 38°C.
- •Major trauma/surgery (≤8 weeks) or planned surgery during the study.
- •Drug abuse history or positive urine drug screen.
- •Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.
研究组 & 干预措施
HRS-5965 Group A
Experimental
干预措施: HRS-5965 Capsules (Drug)
HRS-5965 Group B
Experimental
干预措施: HRS-5965 Capsules (Drug)
结局指标
主要结局
Peak concentration (Cmax) of HRS-5965
时间窗: Day 1 to Day 13.
Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t)
时间窗: Day 1 to Day 13.
次要结局
- Time to peak concentration (Tmax)(Day 1 to Day 13.)
- Adverse events (AEs)(Day 1 to Day 20.)
研究者
研究点 (2)
Loading locations...
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