None listed
Conditions
Interventions
T-R group:On the 1st and 4th day of the experiment, take the test preparation (1 bag) or the reference preparation (1 bag) on an empty stomach (overnight fasting for at least 10h)
R-T group:On the 1st and 4th day of the experiment, take the reference preparation (1 bag) or the test preparation (1 bag) on an empty stomach (overnight fasting for at least 10h)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects, no gender limit; 2. Aged 18 ~ 65 years (including 18 and 65 years old); 3. Weight: Male subjects should generally weigh no less than 50kg (inclusive) and female subjects should generally weigh no less than 45kg (inclusive). Body mass index (BMI) = body weight kg/[(height m)x(height m)], in the range of 19 ~ 26kg/m^2 (including boundary values); 4. Good health condition: no medical history of liver, kidney, endocrine, cardiovascular, digestive tract, nervous, psychiatric, respiratory, tumor, immune, skin, blood or metabolic systems deemed unsuitable for study by researchers; physical examination, laboratory examination and vital sign examination showing normal or abnormal clinical significance; 5. The subject (or his or her partner) has no pregnancy plan, voluntarily takes effective physical contraception and has no sperm or egg donation plan during the study period and within 6 months after the end of the study; 6. Before the trial, subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participated in this clinical trial. Subjects can communicate well with the researchers, comply with the requirements of the whole study, and have signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy: Allergic to omeprazole or its main components (sodium bicarbonate, xanthan gum, sucrose, xylitol, sucralose, mint flavor), or known to be allergic to two or more drugs or food; 2. Hepatitis B surface antigen positive, or hepatitis C antibody positive, or treponema pallidum antibody positive, or HIV antibody positive; 3. Use of any drug that inhibits or induces liver metabolism of the drug in the 28 days prior to study drug administration (Common liver enzyme inducers: barbiturates (phenobarbital was the most common), carbamazepine, aminoluide, griseofulvin, aminopropyl ester, phenytoin sodium, Grumite, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide); 4. Had taken any prescription, over-the-counter, herbal, or health care products within 14 days prior to taking the study drug; 5. Patients who had surgery in the 3 months prior to screening or planned to have surgery during the study period, and those who had surgery that would affect drug absorption, distribution, metabolism or excretion; 6. Excessive consumption of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250mL) per day in the 3 months prior to screening; 7. Those who have eaten food or drink containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, mango, dragon fruit, grape juice, orange juice and other flavonoid or citroside compounds) since screening to 1 day after admission; 8. Special diet patients who have eaten chocolate, any food or drink containing caffeine or xanthine during the period of hospitalization from screening to -1 day, which affects the absorption, distribution, metabolism and excretion of drugs; 9. Patients who donated blood including component blood or substantial blood loss (>=450mL) within 3 months prior to screening, received blood transfusions or used blood products, and planned to donate blood or blood components during the study period and within 3 months after the end of the study; 10. Smoking more than 5 cigarettes per day in the 3 months prior to screening, or not stop using any tobacco products during the test; 11. Those who have smoked or used any tobacco-based product during the screening period or within 24 hours before taking the drug and have tested positive for nicotine; 12. Previous history of drug use, drug abuse and positive urine drug test; 13. Those who consumed more than 14 units of alcohol per week (1 unit of alcohol ˜360mL beer or 45mL 40% spirits or 150mL wine) in the 3 months prior to screening, or who could not abstain from alcohol during the test period; 14. Those who have taken any alcohol-based product during the screening period or within 24 hours before taking the drug, and whose alcohol breath test results are greater than 0.0mg/100mL; 15. Participated in any other clinical trials within 3 months prior to the trial; 16. Patients who have special requirements for food, cannot follow a unified diet (such as intolerance to standard meals) or have difficulty swallowing; 17. Patients who cannot tolerate venipunction and have a history of fainting needle and fainting blood; 18. Pregnant or lactating female patients; Or female patients with a positive pregnancy test; 19. Patients deemed unsuitable for participation by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentration of omeprazole; | — |
Countries
China
Contacts
Public ContactZhang Yu
Outcome results
None listed