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

NCT06495931 | Completed Phase 1

• 1 other identifier: HRS-7535-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• PK parameters：Cmax

  0 hour to 24 hours after the last dosing

• PK parameters：AUC0-t

  0 hour to 24 hours after the last dosing

• PK parameters：AUC0-∞

  0 hour to 24 hours after the last dosing

Secondary Outcomes (5)

• PK parameters：Tmax

  0 hour to 24 hours after the last dosing

• PK parameters： t1/2

  0 hour to 24 hours after the last dosing

• PK parameters： CL/F

  0 hour to 24 hours after the last dosing

• PK parameters： Vz/F

  0 hour to 24 hours after the last dosing

• Incidence and severity of adverse events (AEs)

  from screening to 24 hours after the last dosing

Study Arms (1)

Treatment group A: HRS-1780 tablets、HR20033 tablets、HRS-7535 tablets

EXPERIMENTAL

Drug: HRS-1780 tablets; Drug: HR20033 tablets; Drug: HRS-7535 tablets

Interventions

HRS-1780 tablets DRUG

HRS-1780 tablets, three times

Treatment group A: HRS-1780 tablets、HR20033 tablets、HRS-7535 tablets

HR20033 tablets DRUG

HR20033 tablets, nine times

Treatment group A: HRS-1780 tablets、HR20033 tablets、HRS-7535 tablets

HRS-7535 tablets DRUG

HRS-7535 tablets ，three times or nine times

Treatment group A: HRS-1780 tablets、HR20033 tablets、HRS-7535 tablets

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital ,Capital Medical University

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 15, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)