Healthy VolunteersPhase 1NCT07294846

Drug Interaction Study on Linaprazan Glurate Capsules

A Phase 1 study testing Linaprazan Glurate Capsules, Bismuth Potassium Citrate Capsules and Amoxicillin Capsules in people with Healthy Volunteers and Patients, run by Jiangsu Sinorda Biomedicine Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Patients
What is being tested?: Linaprazan Glurate Capsules, Bismuth Potassium Citrate Capsules and Amoxicillin Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteChina
Study dates: 8 Sep 2025to 15 Dec 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 22Show fewer

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;
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;
Subjects with major surgery within 3 months prior to screening,and planned surgery during trial participation;
Subjects with blood donation (whole blood/component) ≥400 mL within 3 months (excluding menstrual loss),Blood transfusion or blood product use within 3 months;
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);
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;
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;
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;
Subjects who have been vaccinated within the 3 months prior to screening or plan to be vaccinated during the trial period;
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;
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;
Subjects who are intolerant to venipuncture, have difficulty with blood collection, or have a history of needle or blood phobia/syncope;
Pregnant or lactating women;
Subjects with special dietary requirements who cannot comply with the standardized diet, or who have difficulty swallowing;
Subjects deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004

Other trials in China

About this study

Official title: Drug Interaction Study on Linaprazan Glurate Capsules, Clarithromycin Tablets, Amoxicillin Capsules, and Bismuth Potassium Citrate Capsules

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.

Conditions: Healthy Volunteers, Patients
Being tested: Linaprazan Glurate Capsules, Bismuth Potassium Citrate Capsules, Amoxicillin Capsules, Clarithromycin tablets, Esomeprazole Magnesium Enteric-coated Tablets
Keywords: Potassium competitive acid blocker, Acid inhibition, Adjunctive therapy for H. pylori eradication, PK, Linaprazan Glurate Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Linaprazan Glurate CapsulesDrug
Also called Linaprazan Glurate
Linaprazan Glurate capsules
Bismuth Potassium Citrate CapsulesDrug
Also called Bismuth Potassium Citrate
Bismuth Potassium Citrate Capsules
Amoxicillin CapsulesDrug
Also called Amoxicillin
Amoxicillin Capsules
Clarithromycin tabletsDrug
Also called Clarithromycin
Clarithromycin Tablets
Esomeprazole Magnesium Enteric-coated TabletsDrug
Also called Esomeprazole Magnesium
Esomeprazole Magnesium Enteric-coated Tablets

Study groups in NCT07294846
Study group	Role	What they receive
Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period	Experimental	Glurate Capsules Capsules 50mg, BID, consecutive 7-day dosing per period in Part 1. Receives: Drug: Linaprazan Glurate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets
Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing	Experimental	Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing in part 2. Receives: Drug: Linaprazan Glurate Capsules; Drug: Bismuth Potassium Citrate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets
Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.	Experimental	Esomeprazole Magnesium Enteric-coated Tablets 20mg, BID in Part 2. Receives: Drug: Bismuth Potassium Citrate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets; Drug: Esomeprazole Magnesium Enteric-coated Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7, 14 days
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.
Measured: 7, 14 days
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.
Measured: 7, 14 days
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.
Measured: 7 days
Cmax(Maximum observed plasma drug concentration)
Cmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
AUC0-τ (The area under the drug-time curve within the dosing interval)
AUC0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
Tmax (Time to reach maximum plasma concentration)
Tmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
CL/F (apparent clearance)
CL/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
Ae0-τ (Amount of drug excreted in urine over the dosing interval)
Ae0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
fe (Amount of drug excreted in urine over the dosing interval)
fe of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days
CLR (renal clearance)
CLR of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Measured: 14 days

Secondary outcomes (4)

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
Measured: 1, 14 days
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.
Measured: 1, 14 days
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.
Measured: up to 56 days
Number of subjests With Clinically Notable Electrocardiogram (ECG) Values
Record the standard 12-lead ECG.
Measured: up to 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202515 Dec 2025

First posted19 Dec 2025
Study start8 Sep 2025
Primary completion15 Dec 2025
Study completion15 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study investigates the drug-drug interactions (DDI) among Linaprazan Glurate capsules, clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The research plan is divided into two parts: a study in Hp-negative healthy subjects and a study in Hp-positive subjects.
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294846
Sponsor's protocol ID: SND-X842-103
Status last verified: Jan 2026
First submitted: 4 Sep 2025
Last updated: 6 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Interaction Study on Linaprazan Glurate Capsules, Clarithromycin Tablets, Amoxicillin Capsules, and Bismuth Potassium Citrate Capsules
ClinicalTrials.gov ID: NCT07294846
Acronym / sponsor ID: SND-X842-103
Conditions: Healthy Volunteers, Patients
Keywords: Potassium competitive acid blocker, Acid inhibition, Adjunctive therapy for H. pylori eradication, PK, Linaprazan Glurate Capsules
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Jiangsu Sinorda Biomedicine Co., LtdIndustry (pharma, biotech, devices)
Study start: 8 Sep 2025 (actual)
Primary completion: 15 Dec 2025 (actual)
Study completion: 15 Dec 2025 (actual)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This study investigates the drug-drug interactions (DDI) among Linaprazan Glurate capsules, clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The research plan is divided into two parts: a study in Hp-negative healthy subjects and a study in Hp-positive subjects.

Arm	Type	Receives
Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period	Experimental	Drug: Linaprazan Glurate Capsules, Drug: Amoxicillin Capsules, Drug: Clarithromycin tabletsGlurate Capsules Capsules 50mg, BID, consecutive 7-day dosing per period in Part 1.
Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing	Experimental	Drug: Linaprazan Glurate Capsules, Drug: Bismuth Potassium Citrate Capsules, Drug: Amoxicillin Capsules, Drug: Clarithromycin tabletsLinaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing in part 2.
Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.	Experimental	Drug: Bismuth Potassium Citrate Capsules, Drug: Amoxicillin Capsules, Drug: Clarithromycin tablets, Drug: Esomeprazole Magnesium Enteric-coated TabletsEsomeprazole Magnesium Enteric-coated Tablets 20mg, BID in Part 2.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (22 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Linaprazan Glurate CapsulesAlso: Linaprazan GlurateLinaprazan Glurate capsules	Drug	Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing, Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period
Bismuth Potassium Citrate CapsulesAlso: Bismuth Potassium CitrateBismuth Potassium Citrate Capsules	Drug	Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing., Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing
Amoxicillin CapsulesAlso: AmoxicillinAmoxicillin Capsules	Drug	Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing., Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing, Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period
Clarithromycin tabletsAlso: ClarithromycinClarithromycin Tablets	Drug	Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing., Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing, Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period
Esomeprazole Magnesium Enteric-coated TabletsAlso: Esomeprazole MagnesiumEsomeprazole Magnesium Enteric-coated Tablets	Drug	Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.

Primary outcome

Steady state maximum concentration (Cmax,ss)
Time frame: 7 days
Cmax,ss of of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
AUC0-τ,ss(The area under the drug-time curve within the dosing interval after reaching the steady state)
Time frame: 7 days
AUC0-τ,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Cav,ss (Average steady-state blood drug concentration)
Time frame: 7 days
Cav,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Tmax,ss (Steady-state peak time)
Time frame: 7 days
Tmax,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
CLss/F(Steady-state apparent clearance rate)
Time frame: 7 days
CLss/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
t1/2z(Terminal elimination half-life)
Time frame: 7, 14 days
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.
Vz/F (Apparent volume of distribution in the terminal elimination phase)
Time frame: 7, 14 days
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.
λz (Terminal elimination rate constant)
Time frame: 7, 14 days
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.
MRT(mean residence time)
Time frame: 7 days
MRT of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Cmax(Maximum observed plasma drug concentration)
Time frame: 14 days
Cmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
AUC0-τ (The area under the drug-time curve within the dosing interval)
Time frame: 14 days
AUC0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Tmax (Time to reach maximum plasma concentration)
Time frame: 14 days
Tmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
CL/F (apparent clearance)
Time frame: 14 days
CL/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Ae0-τ (Amount of drug excreted in urine over the dosing interval)
Time frame: 14 days
Ae0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
fe (Amount of drug excreted in urine over the dosing interval)
Time frame: 14 days
fe of Pharmacokinetic Parameters of Bismuth in Part 2 study.
CLR (renal clearance)
Time frame: 14 days
CLR of Pharmacokinetic Parameters of Bismuth in Part 2 study.

4 secondary outcomes

The percentage of time over a 24-hour period that intragastric pH ≥ 4 and pH ≥ 6
Time frame: 1, 14 days
Proportion of subjects with successful Helicobacter pylori (Hp) eradication
Time frame: 1, 14 days
Number of subjests With Adverse Events
Time frame: up to 56 days
Number of subjests With Clinically Notable Electrocardiogram (ECG) Values
Time frame: up to 56 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ming Lu study director

Shanghai Sinorda Biomedicine Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady state maximum concentration (Cmax,ss) (time frame: 7 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.