Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
Conditions
Interventions
Experimental group1:fasting TRTR
Experimental group2:fasting RTRT
Experimental group3:TRTR after meal
Experimental group4:RTRT after meal
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy male or female subjects with appropriate gender ratio; 2. Age: over 18 years old (including 18 years old); 3. Male subjects weigh >=50.0kg, females >=45.0kg, and the body mass index is in the range of 19.0~26.0kg/m2 (including the boundary value), body mass index (BMI) = weight (kg) / height 2 (m2) ; 4. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent; 5. The subjects can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or history of drug or food allergy, or known allergy to rabeprazole sodium; 2. The investigator considers clinically significant liver, kidney, endocrine, cardiovascular, neurological, mental, gastrointestinal (such as peptic ulcer disease, chronic gastritis, etc.), lung, tumor, immunity, facial features, Diseases such as skin, reproductive, blood or metabolic disorders or any other diseases, or have a history of these diseases, or have had a history of major surgery, or factors that would compromise the safety of the subject or affect the results of the study; 3. Physical examination, vital sign measurement, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (only for female subjects), serum virology), 12-lead electrocardiogram, and abnormal judgment by the investigator have clinical significance; 4. During the trial and within 3 months after the end of the study, the subject or his partner has a pregnancy plan or is unwilling to use medically acceptable contraceptive methods, or the subject has a sperm/egg donation plan; 5. Pregnant, lactating women, or women of childbearing age who did not take appropriate contraceptive measures within 14 days before enrollment, or who used oral contraceptives within 30 days before the first dose of the study, or who used long-acting estrogen or pregnancy within 3 months before the test Hormone injections or embedded tablets; 6. Has a history of drug abuse, or positive drug abuse and drug tests, or habitually taking any drugs (including Chinese herbal medicine) or functional vitamins; 7. Use of any prescription drugs (including hormone drugs), over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening; 8. Recurrent diarrhea within 14 days before screening; 9. The result of Helicobacter pylori test (exhalation) is positive; 10. Excessive smoking (>=5 cigarettes/day) within 3 months before screening, or smoking within 48 hours before the first dose of the study drug, or positive smoke test at screening, or smoking cannot be discontinued during the trial; 11. Past alcoholism [that is, men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g of alcohol, such as 360ml of beer or 45ml of spirits with an alcohol content of 40% or 150ml of wine) ], or frequent drinking (more than 14 standard units of alcohol per week) within 3 months before screening, or alcohol breath test results at screening greater than 0.0 mg/100 mL, or ingesting any alcohol-containing alcohol within 48 hours before the first dose of the study Food or beverages (such as liquor, beer, wine, rice wine, beer duck, fermented bean curd, egg yolk pie with edible alcohol, Swiss roll, etc.), or the test period cannot be interrupted; 12. Long-term drinking of excessive caffeinated beverages (more than 8 cups a day, 1 cup = 250mL), or intake of any caffeinated food or beverage within 48 hours before the first dose of the study (such as coffee, tea, cola, chocolate) etc.), or the test period cannot be interrupted; 13. Within 48 hours before the first dose of the study, take any grapefruit fruit or food or drink containing grapefruit, or the intake cannot be interrupted during the trial; 14. There are special requirements for diet and cannot comply with a unified diet (such as subjects in the postprandial experimental group are intolerant to hig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum blood concentration;The area under the plasma concentration-time curve from 0 to the last time point t;Area under the plasma concentration-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed