NCT06939504已完成1 期
Evaluation of the Relative Bioavailability of HRS-9813 Capsule and Tablet in Healthy Subjects and the Effect of Food on the Pharmacokinetics of HRS-9813 Capsule
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum observed concentration of HRS-9813 capsule (Cmax)
研究概览
简要总结
This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.
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
- •Aged 18-45 years.
- •Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m
- •Subjects not with clinically significant vital signs and laboratory tests.
- •Take contraception measures.
排除标准
- •Any serious clinical 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 2 weeks before the screening or baseline period.
- •History of smoking or excessive alcohol or drug abuse.
- •Other situations that the researcher judges to be unsuitable.
研究组 & 干预措施
HRS-9813 Capsule Group
Experimental
干预措施: HRS-9813 Capsule (Drug)
HRS-9813 Tablet Group
Experimental
干预措施: HRS-9813 Tablet (Drug)
结局指标
主要结局
Maximum observed concentration of HRS-9813 capsule (Cmax)
时间窗: Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
时间窗: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
时间窗: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
时间窗: Day 1-Day 23.
次要结局
- Adverse events (AEs)(Day 1-Day 23.)
- Time to Cmax of HRS-9813 capsule (Tmax).(Day 1-Day 23.)
- Time to Cmax of HRS-9813 tablet (Tmax).(Day 1-Day 23.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Relative Bioavailability Study of HRS9531 in Healthy SubjectsType 2 DiabetesNCT05893576Fujian Shengdi Pharmaceutical Co., Ltd.50
已完成
1 期
A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and TabletsEndometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted ReproductionNCT05868057Jiangsu HengRui Medicine Co., Ltd.16
已完成
1 期
Study on the Bioavailability of SHR0302 in Healthy SubjectsHealthy SubjectsNCT04712838Jiangsu HengRui Medicine Co., Ltd.24
已完成
1 期
A Clinical Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy SubjectsBreast CancerNCT06619873Shandong Suncadia Medicine Co., Ltd.24
已完成
1 期
A SHR0302 BA Study on Healthy SubjectsAutoimmune DiseasesNCT06202612Jiangsu HengRui Medicine Co., Ltd.16