NCT06084156已完成1 期
A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年8月10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
- 22
- 试验地点
- 1
- 主要终点
- The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
研究概览
简要总结
This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 and Age ≤60 years
- •BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
- •Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.
排除标准
- •Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
- •Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L;
- •Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
- •Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
- •Treatment with an investigational drug within 3 months;
- •Other protocol-defined exclusion criteria.
研究组 & 干预措施
HSK7653 and Metformin
Experimental
干预措施: HSK7653 (Drug)
HSK7653 and Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
时间窗: Day4, day 27 and day 41
The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
时间窗: Day4, day 27 and day 41
次要结局
- Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated(Day 41)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(First dose of study drug up to 62 days after last dose of study drug)
研究者
研究点 (1)
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