None listed
Conditions
Interventions
Bismuth agent group:Subject takes bismuth potassium citrate capsules
Test group:The subjects took Keprazole hydrochloride tablets, clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules
Positive control group:Subjects taking esomeprazole magnesium enteric coated tablets, clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult subjects aged between 18 and 55 years old (including 18 and 55 years old), both male and female; 2. Weight for males = 50.0kg, females = 45.0kg, and body mass index (BMI): 19.00~26.00kg/m2 (including 19.00 and 26.00, BMI=weight/height²); 3. Subjects voluntarily sign informed consent forms; 4. The subject agrees to take appropriate contraceptive measures within 3 months from the signing of the informed consent form to the cessation of medication, to avoid pregnancy for themselves or their partner, and to avoid donating sperm and eggs during this period; 5. The subjects have a good lifestyle and are able to maintain good communication with the researchers and comply with various requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals with a clinically significant history of drug allergies or atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.) or known allergies to investigational ingredients and excipients or PPIs drugs (such as omeprazole, lansoprazole, eprazole, esomeprazole, rabeprazole, etc.), or those with a positive penicillin skin test result one day before administration; 2. Individuals with a history of dizziness/needle fainting and inability to tolerate venous indwelling blood collection; 3. Clinically significant history of abnormal ECG or family history of long QT syndrome (grandparents, parents, brothers and sisters); 4. Inquire about patients with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular, neurological (such as epilepsy), immune, urinary, digestive, liver, kidney, and metabolic abnormalities, or mental disorders; 5. Merge diseases that may affect drug absorption, distribution, metabolism, excretion, and safety data interpretation, or diseases that may reduce compliance, including but not limited to any of the following diseases: History of inflammatory bowel disease, ulcers, gastrointestinal/rectal bleeding, persistent nausea, or other gastrointestinal abnormalities; A significant history of gastrointestinal surgery (such as cholecystectomy, gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass surgery, gastric segmentation surgery, or gastric cystectomy); Evidence of kidney disease or clinically significant impairment of kidney function during screening; Evidence of liver disease or clinically significant liver dysfunction during screening; Urinary tract obstruction or difficulty in emptying urine during screening. 6. Screening period vital signs, physical examinations, electrocardiograms, and laboratory tests (blood routine, blood biochemistry, urine routine, pregnancy test, coagulation function, and preoperative four tests) that have been determined by the researcher to be clinically significant; 7. Those who have been vaccinated one month before the test or who plan to be vaccinated one month after the test (including COVID-19 vaccine); 8. Those who have taken special diets (including dragon fruit, mango, grapefruit, and/or xanthine, as well as products containing caffeine and alcohol, etc.) within 48 hours before administration or who are not prohibited from taking them during the trial period, or engage in vigorous exercise that may affect factors such as drug absorption, distribution, metabolism, and excretion; 9. Prescription drugs, non prescription drugs and health care drugs, including western drugs or traditional Chinese patent medicines and simple preparations, were used within 2 weeks before the test; 10. Individuals who smoke an average of more than 5 cigarettes per day within the 3 months prior to the experiment or who cannot give up smoking throughout the entire hospitalization period; 11. Individuals who frequently drink alcohol within the three months prior to the experiment, i.e. those who consume an average of more than 2 units of alcohol per day (1 unit=360ml of beer or 45ml of 40% alcohol or 150ml of wine) or have a positive alcohol breath test result on the day of check-in (>0.0mg/L); 12. Blood donors or those who have lost = 400ml of blood within 3 months before the trial, or those who have donated blood during the planned trial period and within 3 months after the end of the trial; 13. Those who have participated in othe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss;AUC0-t,ss;AUC0-8,ss;Tmax;t1/2;Cav,ss;CLss/F;Vz/F;Urinary drug excretion volume and cumulative urinary drug excretion rate; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed