healthy subjects
Conditions
Interventions
T-R sequence group:In the first cycle, one tablet of the test product was orally administered on an empty stomach, totaling 20mg
After a 7-day cleaning period, in the second cycle, a total of 20mg of 2 reference tablets were given cross administration.
R-T sequence group:In the first cycle, 2 reference preparations were taken orally on an empty stomach, totaling 20mg
After a 7-day cleaning period, in the second cycle, a total of 20mg of 1 tablet of the test product was administered cross over.
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy adult subjects aged 18 to 45 (including 18 and 45), both male and female; 2. Weight male >= 50.0kg, female >= 45.0kg, and body mass index (BMI): 19.00~26.00kg/m2 (including 19.00 and 26.00, BMI=weight/height 2); 3. Subjects voluntarily sign an informed consent form; 4. The subject agrees to take appropriate contraceptive measures within 3 months after signing the informed consent form and stopping the medication to avoid pregnancy for themselves or their partner. During this period, the subject avoids donating sperm and eggs; 5. Subjects have a good lifestyle and are able to maintain good communication with researchers and comply with various requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1. Persons with a clinically significant history of drug allergy or atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.) or known allergies to experimental drug ingredients and excipients or PPIs drugs (such as omeprazole, lansoprazole, eprazole, esomeprazole, rabeprazole, etc.); 2. Those who have a previous history of blood/needle syncope and cannot tolerate venous indwelling blood collection; 3. A clinically significant history of electrocardiographic abnormalities or a family history of long QT syndrome (grandparents, parents, and siblings); 4. Patients with severe systemic diseases such as respiratory, blood, endocrine, cardiovascular, cerebrovascular, nervous system (such as epilepsy), immune, urinary, digestive, liver, kidney, metabolic abnormalities, or mental disorders during consultation; "Incorporation of diseases that may affect the absorption, distribution, metabolism, excretion, and safety data interpretation of drugs, or 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 large history of gastrointestinal surgery (such as cholecystectomy, gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric segmentation, or gastric banding); Evidence of kidney disease or clinically significant impairment of renal function during screening; Evidence of liver disease or clinically significant liver function impairment during screening; Obstruction of the urinary tract or difficulty in emptying urine during screening. 6. During the screening period, vital signs, physical examination, electrocardiogram, and laboratory tests (blood routine, blood biochemistry, urine routine, pregnancy test, coagulation function, and viral serological screening) 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 it within 48 hours before administration or who cannot be prohibited from taking special diets (including foods such as dragon fruit, mango, grapefruit, and/or xanthine, as well as products containing caffeine and alcohol, etc.) or exercising vigorously, which may affect the absorption, distribution, metabolism, excretion, and other factors of the drug during the trial period; 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. Those who smoke more than 5 cigarettes per day on average within the three months before the trial or who cannot give up smoking during the entire hospitalization period; 11. Regular drinkers within the three months before the trial, i.e., those who consumed more than 2 units of alcohol per day on average (1 unit=360 ml of beer or 45 ml of spirits with an alcohol content of 40% or 150 ml of wine), or those who had evidence of alcohol abuse and excessive consumption during the alcohol breath test at the time of enrollment; 12. Those who donate blood or lose >= 400ml of blood within 3 months before the test, or those who donate blood during the planned test period and within 3 months after the end of the test; 13. Those who have participated in othe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-t;AUC0-8;AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed