CompletedPhase 1

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

China18 participantsStarted 2024-12-31

Plain-language summary

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

Age range18 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 0 hour to 24 hours after the last dosing.

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

Timeframe: 0 hour to 24 hours after the last dosing.

NCT IDNCT06727838

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-25

Who can participate

Age range18 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

What they're measuring

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 0 hour to 24 hours after the last dosing.

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

Timeframe: 0 hour to 24 hours after the last dosing.