Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Heal… (NCT06422039) | Clinical Trial Compass
CompletedPhase 1
Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects
China24 participantsStarted 2024-05-23
Plain-language summary
This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
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
. Able and willing to provide a written informed consent;
. Male or female aged 18-45 at screening (both inclusive);
. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
. Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.
Exclusion criteria
. Those who had a smoking history in the 3 months before screening (average daily smoking \> 5 cigarettes), or could not stop using any tobacco products during the test;
. Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
. Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
. Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
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 72 hours after the last dosing
2
PK parameters：AUC0-t
Timeframe: 0 hour to 72 hours after the last dosing
3
PK parameters：AUC0-∞
Timeframe: 0 hour to 72 hours after the last dosing
4
Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal
Timeframe: 0 hour to 72 hours after the last dosing
5
Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status
Timeframe: 0 hour to 72 hours after the last dosing
. A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
. A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
. Abnormalities with QTcF \> 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant;
. Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant;