NCT06654960已完成1 期
A Single Center, Open-label, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.
研究概览
简要总结
The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- •Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
- •Body weight ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
- •HbA1c<6.0%.
排除标准
- •Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
- •Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
- •Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
- •Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
- •Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
- •Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
- •Allergic constitution includes severe drug allergy or history of drug allergy;
- •Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
- •Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
- •History of hypoglycaemia;
- •The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
研究组 & 干预措施
Single arm
Experimental
干预措施: HRS9531 injection (Drug)
Single arm
Experimental
干预措施: Metformin Hydrochloride tablets (Drug)
结局指标
主要结局
Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.
时间窗: Start of treatment up to 12 hours.
次要结局
- Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Maximum concentration (Cmax) of metformin after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Terminal half-life (t1/2) of metformin after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Clearance (CL/F) of metformin after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment.(Start of Treatment up to 30 hours.)
- Time to maximum concentration (Tmax) of HRS9531.(Start of Treatment up to 504 hours.)
- Maximum concentration (Cmax) of HRS9531.(Start of Treatment up to 504 hours.)
- Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t).(Start of Treatment up to 30 hours.)
- Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf).(Start of Treatment up to 504 hours.)
- Terminal half-life (t1/2) of HRS9531.(Start of Treatment up to 504 hours.)
- Clearance (CL/F) of HRS9531.(Start of Treatment up to 504 hours.)
- Apparent volume of distribution (VzF) of HRS9531.(Start of Treatment up to 504 hours.)
- Incidence and severity of adverse events.(Screening period up to 42 days.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal FunctionContrast-Enhanced Magnetic Resonance Imaging DetectionNCT06657560Shanghai Shengdi Pharmaceutical Co., Ltd41
招募中
1 期
A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy SubjectsType 2 DiabetesNCT06246175Fujian Shengdi Pharmaceutical Co., Ltd.32
Unknown
1 期
A Trial of HR17031 Injection With Hepatic InsufficiencyImproved Glycemic Control in Patients With Type 2 DiabetesNCT05151705Jiangsu HengRui Medicine Co., Ltd.24
已完成
2 期
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes SubjectsType 2 DiabetesNCT05966272Fujian Shengdi Pharmaceutical Co., Ltd.199
已完成
2 期
Efficacy and Safety of HRS9531 Injection in Obese Subjects Without DiabetesOverweight or ObesityNCT05881837Fujian Shengdi Pharmaceutical Co., Ltd.249