Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
Conditions
Interventions
A group of fasting:TRTR
B group of fasting:RTRT
A group of fed:TRTR
B group of fed:RTRT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male or female subjects with appropriate gender ratio; 2. Aged >=18 years old; 3. WeightMale >=50.0kg, female >=45.0kg, and body mass index is in the range of 19.0~26.0kg/m2 (including boundary value). body mass index (BMI) = weight (kg)/height 2 (m2); 4. The subjects must give informed consent of this study before the trial and sign the written informed consent voluntarily; 5. The subjects can communicate with the researchers well, understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. staying in a high-risk area of the epidemic within 14 days, contacting a new crown patient or suspected patient, or entering the country within 14 days; 2. Allergic constitution or a history of drug or food allergy, or known to be allergic to rabeprazole sodium or any component of rabeprazole sodium enteric-coated tablets; 3. Any cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, neurological, psychiatric, immune, skin and metabolic disorders or any other disease considered clinical significance by the investigator through inquiry, or medical history that will endanger the safety of the subject or affect the result of this study, or having a history of major surgery; 4. physical examination, vital sign measurement, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (female subjects only)), 12-lead ECG examination, chest CT examination results the researcher judges that the abnormality is clinically significant ; 5.Abnormal detection of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, and HIV antibody has clinical significance; 6. Pregnant or lactating women, or women who have unprotected sexual intercourse within 14 days before screening, or subjects (or their partners) who are unwilling or unable to take one or more contraceptive measures during the trial period and 6 months after the end of the trial, or male subjects who have a fertilization program for women during the trial period and within 6 months after the end of the trial, or female subjects who have egg donation plan during the trial period and within 6 months after the end of the trial; 7. use of long-acting estrogen, progesterone injections or implants within 6 months before screening; 8. a history of drug abuse or positive results of drug abuse and drug testing (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, tetrahydrocannabinolic acid, cocaine); 9. use of any prescription drugs (including hormone drugs), over-the-counter drugs, Chinese herbs or health care products else; 10. positive result of Helicobacter pylori examination (expiration); 11. Excessive smoking within 6 months before screening (>=5 cigarettes/day), smoking within 48 hours before screening, positive smoking test at screening, or cannot stop smoking during the trial; 12. Drinking more than 14 standard units(1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine) per week within 3 months before screening or alcohol breath test results greater than 0.0 mg/100 mL and no abstinence from alcohol intake from enrollment to the entire trial period; 13. Previous long-term excessive consumption of caffeine-containing beverages (more than 8 cups a day, 1 cup = 250 mL), or intake of any caffeine-containing food or beverage (e.g. coffee, tea, cola, chocolate, etc.) within 48 h before screening, or no interruption during the trial; 14. taking any grapefruit fruit or food or beverage containing grapefruit ingredients within 48 h before screening, or can not interrupt during the test; 15. those who have special requirements for diet, and cannot accept a unified diet (such as intolerance to high-fat meals among subjects in the postprandial test group, etc.); 16. Significantly abnormal diets (e.g. diet, low sodium) have been initiated within 4 weeks before screening; 17. Participated in other clinical trials wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed