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

NCT06727838 | Completed Phase 1

• 1 other identifier: HRS-7535-108
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center, open, fixed-sequence, self-controlled trial design conducted in healthy subjects.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax)

  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)

  0 hour to 24 hours after the last dosing.

• Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  0 hour to 24 hours after the last dosing.

Secondary Outcomes (5)

• Time to reach maximum plasma concentration (Tmax)

  0 hour to 24 hours after the last dosing.

• Terminal half-life ( t1/2)

  0 hour to 24 hours after the last dosing.

• Apparent clearance (CL/F)

  0 hour to 24 hours after the last dosing.

• Apparent volume of distribution (Vz/F)

  0 hour to 24 hours after the last dosing.

• Incidence and severity of adverse events (AEs)

  0 hour to 24 hours after the last dosing.

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: HRS-7535 tablets; Drug: Metformin Hydrochloride Extended-release Tablets; Drug: Metformin Hydrochloride Tablets

Interventions

HRS-7535 tablets DRUG

HRS-7535 tablets.

Treatment group

Metformin Hydrochloride Extended-release Tablets DRUG

Metformin Hydrochloride Extended-release Tablets.

Treatment group

Metformin Hydrochloride Tablets DRUG

Metformin Hydrochloride Tablets.

Treatment group

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;
• Previous history of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers);

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221700, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 31, 2024
• Primary Completion: January 25, 2025
• Study Completion: January 25, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)