Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet (NCT07696091) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet
China40 participantsStarted 2026-07
Plain-language summary
This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans.
Who can participate
Age range
18 Years – 55 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
. The participants voluntarily signed the informed consent form, fully understanding the purpose and significance of this trial and willing to abide by the trial protocol.
. Age range: 18 - 55 years old (inclusive of both boundaries), open to both genders.
. Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = weight (kg) / height² (m²). BMI is within the range of 19 to 28 kg/m² (including the boundary values).
. Male and female participants with reproductive capacity, as well as their partners, should have no plans for conception or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last administration of the drug, and should voluntarily adopt effective contraceptive measures. For female participants with reproductive capacity, the serum pregnancy test must be negative before the first administration of the drug, and they should not be in the lactation period.
Exclusion criteria
. Those who smoked more than 5 cigarettes per day in the previous 3 months (or used any nicotine-containing products), or those who planned to use any tobacco products during the trial period.
. Select individuals who have consumed alcohol frequently within the past 6 months (for women, the daily alcohol intake exceeds 15 g, and for men, it exceeds 25 g \[5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low-alcohol liquor\]; and who cannot stop using any alcoholic products during the trial period); or those whose alcohol breath test was positive at baseline.
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
Cmax; The maximum plasma concentration
Timeframe: Day1-Day38
2
AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration
Timeframe: Day1-Day38
3
AUC0-inf；Area under the concentration curve from time 0 to extrapolated infinite time
. Those with a history of drug abuse, drug use, drug dependence (during the consultation), or positive results from the baseline urine drug screening.
. Within one month before administration, having donated blood or experiencing blood loss of a total volume of ≥ 200 mL, or having donated blood or experienced blood loss of a total volume of ≥ 400 mL within the previous three months; or having received blood transfusion within the previous eight weeks; or having difficulty in venous blood collection, or being physically unable to withstand intensive blood collection.
. The researchers believe that participants who have other factors that make them unsuitable to participate in this trial.
. The results of physical examination, vital signs, laboratory tests (such as blood routine, urine routine, liver and kidney function, blood biochemistry, coagulation function, thyroid function, etc.), chest imaging, abdominal B-ultrasound and 12-lead electrocardiogram examination, when judged abnormal by the researchers, have clinical significance.
. Those who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
. Suspected of being allergic to the studied drug or any component of the drug, or having a severe allergy to any medication, food, toxin or other exposure.