DiabetesPhase 1NCT06727838
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human
A Phase 1 study testing HRS-7535 tablets, Metformin Hydrochloride Extended-release Tablets and Metformin Hydrochloride Tablets in people with Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study was a single-center, open, fixed-sequence, self-controlled trial design conducted in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- HRS-7535 tablets, Metformin Hydrochloride Extended-release Tablets and Metformin Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 25 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign informed consent before the start of activities related to this experiment, be able to communicate well with the investigators, understand the procedures and methods of this experiment, and be willing to strictly follow the clinical trial protocol to complete this experiment;
- Healthy male aged 18-50 years old (including both ends of the value, subject to the signing of the informed consent);
- Weight ≥ 50 kg, and body mass index (BMI): 22~26 kg/m2 (including both ends of the value);
- Signed informed consent to have no birth plan for 6 months after the last dose, and agreed to take effective contraceptive measures.
Who cannot join
- Have a history of drug or food allergy, or are allergic;
- Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors affecting the administration and absorption of drugs;
- QTcF > 450 ms was detected by 12-lead electrocardiogram during screening or there were other abnormalities that were clinically significant as determined by the investigator;
- Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;
- Those who smoked more than 5 cigarettes per day in the 3 months prior to screening and could not stop using any tobacco products during the test;
- Regular drinkers in the 6 months prior to screening, i.e. those who drink more than 14 units of alcohol per week (1 unit = 285 mL for beer, or 25 mL for spirits, or 100 mL for wine) and cannot stop using any alcohol-containing products during the test period, who test positive for alcohol breath test;
Show all 20Show fewer
- Patients with a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration;
- Patients who have received any surgery within 6 months before screening;
- Participants who have participated in clinical trials of any drug or medical device within 3 months prior to screening (subject to receiving experimental drugs or medical device intervention);
- Blood donation (or blood loss) and blood donation (or blood loss) ≥ 400 mL within 3 months before screening, or receiving blood transfusion;
- Patients who had any clinically significant acute disease within 1 month before screening;
- People who have taken any prescription, over-the-counter, Chinese herbal or health product within 14 days prior to taking the study drug, and plan to take any drug or health product other than the study drug during the trial;
- Patients with a history of severe hypoglycemia;
- People with a history of recurrent urinary tract infections, diabetes insipidus or/and genital fungal infections;
- Previous history of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers);
- Previous history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, previous history of pancreatitis or symptomatic gallbladder disease;
- 48h before the first dose until the end of the study, subjects refused to stop drinking or eating foods with high methylxanthine content, such as coffee, tea, cola, chocolate, etc.; For 7 days prior to the first dose until the end of the study, subjects refused to discontinue any beverage or food containing grapefruit; Those who have special dietary requirements and cannot comply with a unified diet;
- Physical examination, vital signs, laboratory examination, abdominal ultrasound, chest film and other abnormal and clinically significant examination results;
- Persons who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the trial period;
- Subjects with other factors deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221700
About this study
Official title: A Single-center, Open-label, Fixed-sequence, Self-controlled Pharmacokinetics Study of Metformin and HRS-7535 in Healthy Subjects
This study was a single-center, open, fixed-sequence, self-controlled trial design conducted in healthy subjects.
- Conditions
- Diabetes
- Being tested
- HRS-7535 tablets, Metformin Hydrochloride Extended-release Tablets, Metformin Hydrochloride Tablets
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535 tabletsDrug
HRS-7535 tablets.
Metformin Hydrochloride Extended-release TabletsDrug
Metformin Hydrochloride Extended-release Tablets.
Metformin Hydrochloride TabletsDrug
Metformin Hydrochloride Tablets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: HRS-7535 tablets; Drug: Metformin Hydrochloride Extended-release Tablets; Drug: Metformin Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 0 hour to 24 hours after the last dosing.
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
Measured: 0 hour to 24 hours after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: 0 hour to 24 hours after the last dosing.
Secondary outcomes (5)
Time to reach maximum plasma concentration (Tmax)
Measured: 0 hour to 24 hours after the last dosing.
Terminal half-life ( t1/2)
Measured: 0 hour to 24 hours after the last dosing.
Apparent clearance (CL/F)
Measured: 0 hour to 24 hours after the last dosing.
Apparent volume of distribution (Vz/F)
Measured: 0 hour to 24 hours after the last dosing.
Incidence and severity of adverse events (AEs)
Measured: 0 hour to 24 hours after the last dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start31 Dec 2024
- Primary completion25 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727838
- Sponsor's protocol ID
- HRS-7535-108
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Fixed-sequence, Self-controlled Pharmacokinetics Study of Metformin and HRS-7535 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06727838
- Acronym / sponsor ID
- HRS-7535-108
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a single-center, open, fixed-sequence, self-controlled trial design conducted in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: HRS-7535 tablets, Drug: Metformin Hydrochloride Extended-release Tablets, Drug: Metformin Hydrochloride Tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign informed consent before the start of activities related to this experiment, be able to communicate well with the investigators, understand the procedures and methods of this experiment, and be willing to strictly follow the clinical trial protocol to complete this experiment;
- Healthy male aged 18-50 years old (including both ends of the value, subject to the signing of the informed consent);
- Weight ≥ 50 kg, and body mass index (BMI): 22~26 kg/m2 (including both ends of the value);
- Signed informed consent to have no birth plan for 6 months after the last dose, and agreed to take effective contraceptive measures.
Key exclusion criteria (20 listed)
- Have a history of drug or food allergy, or are allergic;
- Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors affecting the administration and absorption of drugs;
- QTcF > 450 ms was detected by 12-lead electrocardiogram during screening or there were other abnormalities that were clinically significant as determined by the investigator;
- Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;
- Those who smoked more than 5 cigarettes per day in the 3 months prior to screening and could not stop using any tobacco products during the test;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7535 tabletsHRS-7535 tablets. | Drug | Treatment group |
| Metformin Hydrochloride Extended-release TabletsMetformin Hydrochloride Extended-release Tablets. | Drug | Treatment group |
| Metformin Hydrochloride TabletsMetformin Hydrochloride Tablets. | Drug | Treatment group |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 0 hour to 24 hours after the last dosing.
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
Time frame: 0 hour to 24 hours after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: 0 hour to 24 hours after the last dosing.
5 secondary outcomes
Time to reach maximum plasma concentration (Tmax)
Time frame: 0 hour to 24 hours after the last dosing.
Terminal half-life ( t1/2)
Time frame: 0 hour to 24 hours after the last dosing.
Apparent clearance (CL/F)
Time frame: 0 hour to 24 hours after the last dosing.
Apparent volume of distribution (Vz/F)
Time frame: 0 hour to 24 hours after the last dosing.
Incidence and severity of adverse events (AEs)
Time frame: 0 hour to 24 hours after the last dosing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7535 tablets, Metformin Hydrochloride Extended-release Tablets and Metformin Hydrochloride Tablets in people with Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: 0 hour to 24 hours after the last dosing.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.