Drug Interaction Study on Linaprazan Glurate Capsules (NCT07294846) | Clinical Trial Compass
CompletedPhase 1
Drug Interaction Study on Linaprazan Glurate Capsules
China56 participantsStarted 2025-09-08
Plain-language summary
This study is a drug-drug interaction (DDI) investigation involving Linaprazan Glurate capsules and a combination of clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The study plan is divided into two parts: one involving Hp-negative healthy subjects and the other involving Hp-positive subjects.
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
. Age range: 18 to 55 years old (including 18 and 55);
. Male weight ≥50.0 kg, female weight ≥45.0 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m²(including critical value); BMI=weight/height2 (m2)
. Part 1 Study and Part 2 Study:
. From signing informed consent until 3 months after study completion, subjects must: Implement appropriate and effective contraception to prevent pregnancy (applies to subject or partner); Refrain from sperm donation or egg donation plans;
. Subjects must fully comprehend the trial content, voluntarily participate in the trial, Provide written informed consent;
Exclusion criteria
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
Steady state maximum concentration (Cmax,ss)
Timeframe: 7 days
2
AUC0-τ,ss(The area under the drug-time curve within the dosing interval after reaching the steady state)
Timeframe: 7 days
3
Cav,ss (Average steady-state blood drug concentration)
Timeframe: 7 days
4
Tmax,ss (Steady-state peak time)
Timeframe: 7 days
5
CLss/F(Steady-state apparent clearance rate)
Timeframe: 7 days
6
t1/2z(Terminal elimination half-life)
Timeframe: 7, 14 days
7
Vz/F (Apparent volume of distribution in the terminal elimination phase)
. Subjects known as Hypersensitivity History: Known allergy to: Linaprazan Glurate capsules, Esomeprazole (Part 2 only), Penicillin, Macrolide antibiotics, Any component of bismuth potassium citrate;History of severe immediate hypersensitivity to: Other macrolide antibiotics, β-lactam agents (e.g., cephalosporins, carbapenems, monobactams),Multiple drug hypersensitivity (e.g., allergic reactions to ≥2 medications/foods);
. Clinically Significant Abnormalities at Screening: Abnormalities deemed clinically significant by investigators based on: Medical history review, Vital signs, Physical examination, 12-lead ECG, Laboratory tests: Complete blood count (CBC), Blood chemistry, Urinalysis, Coagulation tests ;
. Subjects with Penicillin sodium skin test positivity during screening;
. Subjects with use of any investigational product within 3 months prior to screening;
. Subjects with use of potassium-competitive acid blockers (P-CABs) within 3 months prior to screening;
. Subjects with use within 30 days prior to screening of Prescription drugs, Over-the-counter ,OTC) medications, Herbal medicines, Dietary supplements;
. Subjects with history of diseases in the following systems (also investigator-determined as ineligible): Central nervous system, Cardiovascular system, Respiratory system, Digestive system, Endocrine system, Immune system, Neurological/Psychiatric systems, Hematologic/Lymphatic systems, Musculoskeletal system;
. Gastrointestinal/Surgical History: History of gastrointestinal diseases or surgeries including:Gastric surgery (except pyloromyotomy for infantile pyloric stenosis), Cholecystectomy, Vagotomy, Bowel resection, Any surgery potentially affecting GI motility, pH, or absorption, Conditions impacting drug ADME: Dysphagia, Vomiting, Severe diarrhea;
λz (Terminal elimination rate constant)
Timeframe: 7, 14 days
9
MRT(mean residence time)
Timeframe: 7 days
10
Cmax(Maximum observed plasma drug concentration)
Timeframe: 14 days
11
AUC0-τ (The area under the drug-time curve within the dosing interval)
Timeframe: 14 days
12
Tmax (Time to reach maximum plasma concentration)
Timeframe: 14 days
13
CL/F (apparent clearance)
Timeframe: 14 days
14
Ae0-τ (Amount of drug excreted in urine over the dosing interval)
Timeframe: 14 days
15
fe (Amount of drug excreted in urine over the dosing interval)