Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7… (NCT06495931) | Clinical Trial Compass
CompletedPhase 1
Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human
China24 participantsStarted 2024-07-15
Plain-language summary
This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial in healthy subjects.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PK parameters：Cmax
Timeframe: 0 hour to 24 hours after the last dosing
2
PK parameters：AUC0-t
Timeframe: 0 hour to 24 hours after the last dosing
3
PK parameters：AUC0-∞
Timeframe: 0 hour to 24 hours after the last dosing
. 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;