NCT06658964尚未招募1 期
A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects
Jemincare0 个研究点目标入组 48 人开始时间: 2024年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Cmax of JMKX003142 in plasma
研究概览
简要总结
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
- •Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
- •The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
排除标准
- •HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
- •At the time of screening, the vital signs are within the following ranges: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg, pulse <50 bpm or >100 bpm and ear temperature 37.5℃or<35℃,
- •More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
- •Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
结局指标
主要结局
Cmax of JMKX003142 in plasma
时间窗: approximately 5 days after JMKX003142 administered
Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
AUC of JMKX003142 in plasma
时间窗: approximately 5 days after JMKX003142 administered
AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
次要结局
未报告次要终点
研究者
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