NCT06066060已完成1 期
Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Jemincare1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年9月17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
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
研究概览
简要总结
A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.
详细描述
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Healthy Chinese subjects aged 18-45 years, male or female;
- •Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;
- •Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
- •Able to provide written informed consent voluntarily.
排除标准
- •Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
- •History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
- •Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
- •Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
- •Other conditions unsuitable for the study confirmed by the investigator.
研究组 & 干预措施
JMKX000623/Metformin/ JMKX000623+Metformin
Experimental
D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin
干预措施: JMKX000623 (Drug)
JMKX000623/Metformin/ JMKX000623+Metformin
Experimental
D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
时间窗: baseline through 4 days post-dose
Maximum observed After Reaching steady state concentration (Css,max)
时间窗: baseline through 4 days post-dose
次要结局
- Adverse events (AEs)(baseline through 4 days post-dose)
研究者
研究点 (1)
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