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NCT06654960CompletedPhase 1

Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

A Single Center, Open-label, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects

Source: ClinicalTrials.gov · Last updated 7 Jan 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
20 (actual)
First submitted
21 Oct 2024
Start date
5 Nov 2024
Primary completion date
26 Dec 2024
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
NCT number
NCT06654960

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 20
  • From 5 Nov 2024 to the primary completion date, 26 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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;
  • 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;
  • History of hypoglycaemia;

Lab values

  • Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;

Other

  • The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Who the study is looking for

  • 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%.

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital Of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.