Phase
Condition
N/ATreatment
Keverprazan Hydrochloride tablets + low dose amoxicillin
Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)
Keverprazan Hydrochloride tablets + high dose amoxicillin
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 to 75 years;
Adult subjects who voluntarily signed written informed consent approved by theethics committee to consent to participate in this study before the start of anystudy procedure;
Subjects who can understand and comply with the protocol requirements and agree toattend all study visits;
During the screening phase, patients who were Hp positive and required Hperadication therapy as judged by the investigator, and patients who had failed Hperadication for the first time;
Participants agreed to use appropriate medical methods of contraception (exceptmedically sterilized status) during the study.
Exclusion
Exclusion Criteria:
- Participated in other clinical studies within 4 weeks before screening; 2.Pregnant or lactating women; 3. Known allergy to keverprazan, esomeprazole,penicillins or other beta-lactams, macrolide antibiotics, nitrofuran antibiotics, orbismuth (including any relevant adjuvants). If skin sensitivity testing (skintesting) was required, it was performed at visit 1 according to routine medicalpractice; 4. Participants had a history of drug (including but not limited toopioids) abuse or alcohol abuse (> 14 units of alcohol per week, 1 unit of alcohol ≈360mL of approximately 5% beer or 45 ml of approximately 40% spirits or 150 ml ofapproximately 12% wine) in the year before the screening visit; 5. The subjects hadZolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acidhypersecretion; 6. The subject has undergone previous surgery or operation that mayaffect gastric acid secretion or drug absorption, such as subtotal gastrectomy,total gastrectomy, vagotomy, intestinal resection, etc. Simple surgery forperforation, appendectomy, cholecystectomy, and endoscopic resection of benigntumors are acceptable; 7. "Warning" symptoms such as odynophagia, severe dysphagia,bleeding, weight loss, anemia, or hematochezia that might indicate the presence of amalignant GI lesion, unless a malignant lesion was ruled out by endoscopy; 8. Ahistory of malignancy within 5 years before screening (participants were allowed toparticipate if they had been cured of skin basal cell carcinoma or cervicalcarcinoma in situ); 9.. Upper gastrointestinal endoscopy showed acute uppergastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric orduodenal mucosal injury; 10. According to the investigator's judgment, the subjecthas uncontrolled and unstable liver, kidney, cardiovascular, respiratory,gastrointestinal, endocrine, hematological, central nervous system or mentaldiseases, etc., and participating in the study may affect the safety of the subjector the interpretation of the study results; 11. Subjects who plan to be hospitalizedfor surgical treatment during the study; 12. H2-receptor antagonist or PPI usewithin 14 days prior to screening 13C-urea breath test; During the screening period,antibiotics, bismuth and some traditional Chinese medicine with antibacterial effectwere taken within 28 days before 13C-urea breath test; 13. Abnormal laboratory testresults at screening in any of the following: AST > upper limit of normal (ULN); ALT > Upper limit of normal (ULN); Total bilirubin > ULN; creatinine > 1.5 times ULN;
- The subjects had clinically significant abnormal electrocardiogram (ECG),including severe arrhythmia, multifocal premature ventricular contractions (PVC),second degree or above atrioventricula
Study Design
Connect with a study center
Eighth Affiliated Hospital,Sun Yet-san University
Shenzhen, Guangdong 518033
ChinaSite Not Available
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou 1809858, Guangdong 1809935 510655
ChinaActive - Recruiting
Puning Overseas Chinese Hospital
Puning 1802940, Guangdong 1809935 515300
ChinaActive - Recruiting
Eighth Affiliated Hospital,Sun Yet-san University
Shenzhen 1795565, Guangdong 1809935 518033
ChinaActive - Recruiting
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang 1790587, Hubei 1806949 441000
ChinaActive - Recruiting

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