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 range18 Years – 55 Years
SexALL
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
✕. 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;
What they're measuring
1
Steady state maximum concentration (Cmax,ss)
Timeframe: 7 days
2
AUC0-Ï„,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 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;
MRT(mean residence time)
Timeframe: 7 days
10
Cmax(Maximum observed plasma drug concentration)
Timeframe: 14 days
11
AUC0-Ï„ (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-Ï„ (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)