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CompletedNCT07294846Updated Jan 6, 2026

Drug Interaction Study on Linaprazan Glurate Capsules

A Phase 1 interventional study of Linaprazan Glurate Capsules and Bismuth Potassium Citrate Capsules in Healthy Volunteers and Patients, sponsored by Jiangsu Sinorda Biomedicine Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Jiangsu Sinorda Biomedicine Co., Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

The first part of the study is designed as a single-center, randomized, open-label, four-period, four-sequence crossover trial to evaluate the changes in pharmacokinetic (PK) profiles of Linaprazan Glurate capsules when co-administered with clarithromycin tablets and amoxicillin capsules compared to their individual administration, as well as the safety and tolerability of the combination therapy in Hp-negative healthy adult Chinese subjects.

The second part of the study is designed as a single-center, randomized, open-label, parallel-group, positive-controlled trial to compare the differences in systemic exposure of bismuth potassium citrate capsules between the Linaprazan Glurate capsule-based quadruple therapy (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules) and the esomeprazole magnesium enteric-coated tablet-based quadruple therapy (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules), to evaluate the pharmacodynamic effects on intragastric pH, to assess the safety and tolerability of the Linaprazan Glurate capsule-based quadruple therapy, and to preliminarily explore its efficacy in eradicating Helicobacter pylori (Hp) in Hp-positive subjects.

02

Conditions studied

  • Healthy Volunteers
  • Patients

Keywords

  • Potassium competitive acid blocker
  • Acid inhibition
  • Adjunctive therapy for H. pylori eradication
  • PK
  • Linaprazan Glurate Capsules
03

In context

Lead sponsor

Jiangsu Sinorda Biomedicine Co., Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age range: 18 to 55 years old (including 18 and 55);
  2. 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)

  3. Part 1 Study and Part 2 Study:

    Part 1: Subjects must be Helicobacter pylori-negative at screening; Part 2: Subjects must be Helicobacter pylori-positive at screening;

  4. 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;
  5. Subjects must fully comprehend the trial content, voluntarily participate in the trial, Provide written informed consent;

Exclusion criteria

Exclusion Criteria:

  1. 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);
  2. 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 ;
  3. Subjects with Penicillin sodium skin test positivity during screening;
  4. Subjects with use of any investigational product within 3 months prior to screening;
  5. Subjects with use of potassium-competitive acid blockers (P-CABs) within 3 months prior to screening;
  6. Subjects with use within 30 days prior to screening of Prescription drugs, Over-the-counter ,OTC) medications, Herbal medicines, Dietary supplements;
  7. 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;
  8. 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;
  9. Cardiac Abnormalities: Clinically significant ECG abnormality history, Family history of Long QT Syndrome (grandparents, parents, siblings), Screening QTcF prolongation: 450 msec in males, 470 msec in females;
  10. Subjects with major surgery within 3 months prior to screening,and planned surgery during trial participation;
  11. Subjects with blood donation (whole blood/component) ≥400 mL within 3 months (excluding menstrual loss),Blood transfusion or blood product use within 3 months;
  12. Infectious Disease Screening: Positive results for any at screening: Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), Treponema pallidum antibody (TP-Ab);
  13. Subjects who have used illicit drugs within the 3 months prior to screening, or have a history of drug abuse within the past 12 months, or whose urine drug abuse screening test result is positive;
  14. Subjects who regularly consumed alcohol within the 3 months prior to screening (i.e., consuming more than 14 standard units per week; 1 unit = 360mL of beer, or 45mL of 40% spirits, or 150mL of wine), or who are unwilling to abstain from alcohol or any alcohol-containing products for 48 hours prior to dosing and during the trial, or whose alcohol breath test result is positive;
  15. Subjects who smoked an average of >5 cigarettes per day within the 30 days prior to screening; or who cannot guarantee abstinence from smoking from the signing of the informed consent form until the end of the study;
  16. Subjects who have been vaccinated within the 3 months prior to screening or plan to be vaccinated during the trial period;
  17. Subjects who consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day; 1 cup = 250mL) within the 4 weeks prior to screening;
  18. Subjects who consumed special diets (including pitaya, mango, grapefruit, pomelo, lime, starfruit, or foods/beverages prepared from them, or any caffeinated foods/beverages, alcoholic beverages, or other foods/beverages known to affect drug absorption, distribution, metabolism, or excretion) within 48 hours prior to the first dose;
  19. Subjects who are intolerant to venipuncture, have difficulty with blood collection, or have a history of needle or blood phobia/syncope;
  20. Pregnant or lactating women;
  21. Subjects with special dietary requirements who cannot comply with the standardized diet, or who have difficulty swallowing;
  22. Subjects deemed unsuitable for participation by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period

    Glurate Capsules Capsules 50mg, BID, consecutive 7-day dosing per period in Part 1.

    Drug: Linaprazan Glurate Capsules · Drug: Amoxicillin Capsules · Drug: Clarithromycin tablets

  • Experimental
    Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing

    Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing in part 2.

    Drug: Linaprazan Glurate Capsules · Drug: Bismuth Potassium Citrate Capsules · Drug: Amoxicillin Capsules · Drug: Clarithromycin tablets

  • Experimental
    Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.

    Esomeprazole Magnesium Enteric-coated Tablets 20mg, BID in Part 2.

    Drug: Bismuth Potassium Citrate Capsules · Drug: Amoxicillin Capsules · Drug: Clarithromycin tablets · Drug: Esomeprazole Magnesium Enteric-coated Tablets

Interventions

  • DrugLinaprazan Glurate Capsules

    Linaprazan Glurate capsules

    Also known as: Linaprazan Glurate

  • DrugBismuth Potassium Citrate Capsules

    Bismuth Potassium Citrate Capsules

    Also known as: Bismuth Potassium Citrate

  • DrugAmoxicillin Capsules

    Amoxicillin Capsules

    Also known as: Amoxicillin

  • DrugClarithromycin tablets

    Clarithromycin Tablets

    Also known as: Clarithromycin

  • DrugEsomeprazole Magnesium Enteric-coated Tablets

    Esomeprazole Magnesium Enteric-coated Tablets

    Also known as: Esomeprazole Magnesium

06

What researchers measure

Primary outcomes

  1. Steady state maximum concentration (Cmax,ss)

    Cmax,ss of of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  2. AUC0-τ,ss(The area under the drug-time curve within the dosing interval after reaching the steady state)

    AUC0-τ,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  3. Cav,ss (Average steady-state blood drug concentration)

    Cav,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  4. Tmax,ss (Steady-state peak time)

    Tmax,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  5. CLss/F(Steady-state apparent clearance rate)

    CLss/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  6. t1/2z(Terminal elimination half-life)

    t1/2z of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and t1/2z of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 7, 14 days

  7. Vz/F (Apparent volume of distribution in the terminal elimination phase)

    Vz/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and Vz/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 7, 14 days

  8. λz (Terminal elimination rate constant)

    λz of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and λz of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 7, 14 days

  9. MRT(mean residence time)

    MRT of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

    Time frame: 7 days

  10. Cmax(Maximum observed plasma drug concentration)

    Cmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  11. AUC0-τ (The area under the drug-time curve within the dosing interval)

    AUC0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  12. Tmax (Time to reach maximum plasma concentration)

    Tmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  13. CL/F (apparent clearance)

    CL/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  14. Ae0-τ (Amount of drug excreted in urine over the dosing interval)

    Ae0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  15. fe (Amount of drug excreted in urine over the dosing interval)

    fe of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

  16. CLR (renal clearance)

    CLR of Pharmacokinetic Parameters of Bismuth in Part 2 study.

    Time frame: 14 days

Secondary outcomes

  1. The percentage of time over a 24-hour period that intragastric pH ≥ 4 and pH ≥ 6

    Percentage of time with intragastric pH ≥ 4 and ≥ 6 during 24-hour monitoring

    Time frame: 1, 14 days

  2. Proportion of subjects with successful Helicobacter pylori (Hp) eradication

    Proportion of subjects with successful Helicobacter pylori (Hp) eradication confirmed by ¹³C-UBT or ¹⁴C-UBT.

    Time frame: 1, 14 days

  3. Number of subjests With Adverse Events

    Adverse event severity was graded from 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Time frame: up to 56 days

  4. Number of subjests With Clinically Notable Electrocardiogram (ECG) Values

    Record the standard 12-lead ECG.

    Time frame: up to 56 days

07

Study locations

1 site
  • The Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou 550004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07294846
Lead sponsor
Jiangsu Sinorda Biomedicine Co., Ltd
Responsible party
Sponsor
First posted
Dec 19, 2025
Start date
Sep 8, 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Jan 6, 2026

Study contacts

Ming Lu
study director · Shanghai Sinorda Biomedicine Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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