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Type 2 Diabetes MellitusPhase 1NCT06495931

Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human

A Phase 1 study testing HRS-1780 tablets, HR20033 tablets and HRS-7535 tablets in people with Type 2 Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial 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
Type 2 Diabetes Mellitus
What is being tested?
HRS-1780 tablets, HR20033 tablets and HRS-7535 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
15 Jul 2024to 13 Aug 2024
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;
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  • 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;
  • Prior to screening, gastrointestinal surgery that can lead to malabsorption, or long-term use of drugs that have a direct effect on gastrointestinal motility. Have undergone bariatric surgery or procedures (such as gastric banding), or have used drugs with weight reduction effects (including but not limited to orlistat) in the 3 months prior to administration, or have experienced a weight change of more than 10% in the 3 months prior to administration;
  • Use of drugs that may affect glucose metabolism (e.g. systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) or/and exposure to metformin and/or SGLT2 inhibitors within 1 month prior to screening;
  • 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;
  • 48 h 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

  • Xuanwu Hospital ,Capital Medical University

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: A Single-center, Single-arm, Open, Fixed-sequence, Self-controlled Study of the Pharmacokinetic Effects of HRS-1780, Henagliflozin, Metformin, and HRS-7535 in Healthy Subjects

This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial in healthy subjects.

Being tested
HRS-1780 tablets, HR20033 tablets, HRS-7535 tablets
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-1780 tabletsDrug

    HRS-1780 tablets, three times

  • HR20033 tabletsDrug

    HR20033 tablets, nine times

  • HRS-7535 tabletsDrug

    HRS-7535 tablets ，three times or nine times

Study groups in NCT06495931
Study groupRoleWhat they receive
Treatment group A: HRS-1780 tablets、HR20033 tablets、HRS-7535 tabletsExperimentalNot described
Receives: Drug: HRS-1780 tablets; Drug: HR20033 tablets; Drug: HRS-7535 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK parameters：Cmax

    Measured: 0 hour to 24 hours after the last dosing

  2. PK parameters：AUC0-t

    Measured: 0 hour to 24 hours after the last dosing

  3. PK parameters：AUC0-∞

    Measured: 0 hour to 24 hours after the last dosing

Secondary outcomes (5)

  1. PK parameters：Tmax

    Measured: 0 hour to 24 hours after the last dosing

  2. PK parameters： t1/2

    Measured: 0 hour to 24 hours after the last dosing

  3. PK parameters： CL/F

    Measured: 0 hour to 24 hours after the last dosing

  4. PK parameters： Vz/F

    Measured: 0 hour to 24 hours after the last dosing

  5. Incidence and severity of adverse events (AEs)

    Measured: from screening 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.

  1. First posted11 Jul 2024
  2. Study start15 Jul 2024
  3. Primary completion13 Aug 2024
  4. Study completion13 Aug 2024

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06495931
Sponsor's protocol ID
HRS-7535-105
Status last verified
Apr 2026
First submitted
3 Jul 2024
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-1780 tablets, HR20033 tablets and HRS-7535 tablets in people with Type 2 Diabetes Mellitus, 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 22 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?

PK parameters：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?

On the ClinicalTrials.gov record for NCT06495931.

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.

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