reflux esophagitis
Conditions
Interventions
Test preparation - reference preparation:Single cross-fasting
Reference preparation - Test preparation:Single cross-fasting
Test preparation - reference preparation:Single cross-fittting
Reference preparation - Test preparation:Single cross-fittting
Sponsors
Shulan(Hang Zhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All of the following Inclusion criteria need to be met: 1. Before the test, the subjects fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in the test and sign the informed consent. 2. Can complete research in accordance with the requirements of the pilot program. 3. Subjects (including partners) who do not plan to become pregnant and voluntarily use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the trial drug. 4. Healthy male or female, age 18 to 65 years, inclusive. 5. Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg, Body mass index (BMI) 18-28 kg/m2, inclusive. 6. No clinically significant abnormal findings at screening on physical examination, medical history.
Exclusion criteria
Exclusion criteria: Excluded if 1 exclusion criterion is met: 1. Smoked more than 5 cigarettes per day in the 3 months prior to the trial. 2. History of allergy to the test drug, allergies(two or more drug and food allergies). 3. Regularly drank alcohol in the 6 months prior to screening (drinking more than 14 units per week: 1 unit ˜360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine). 4. Blood donation or significant blood loss (>450 mL) within three months prior to screening. 5. Took any drug that alters liver enzyme activity 28 days prior to screening (e.g., CYP3A4 inducers-barbiturates, phenytoin, rifampin, carbamazepine, St. John's wort, etc.; CYP3A4 inhibitors-azanavir, rilpivirine, clarithromycin, ritonavir, diltiazem, cimetidine, verapamil, etc.) 6. Use of any medication within the 14 days prior to initiation of any prescription drug, over-the-counter drug, any vitamin product or herbal remedy. 7. Those who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks prior to screening, or other factors that affect the absorption, distribution, metabolism, or excretion of drugs. 8. Recent significant changes in eating or exercise habits. 9. Have taken an study drug or participated in a clinical trial of a drug within three months prior to taking the dury drug. 10. History of dysphagia or any gastrointestinal disorder that interferes with drug absorption. 11. Any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers. 12. Subjects unable to tolerate a standard meal (two hard-boiled eggs, a slice of buttered bacon toast, a box of fried potato fries, a glass of whole milk) (only for subjects in the fed dosing group). 13. Clinically significant abnormal findings at screening on ECG. 14. Female subjects who are breastfeeding or have a positive seropregnancy result during the screening period or during the course of the trial. 15. Clinically significant abnormalities on clinical laboratory tests, or other clinical findings in the 12 months prior to screening that indicate clinically significant disease(including, but not limited to, gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, oncological, pulmonary, immunological, psychiatric or cardiovascular diseases). 16. Those who have positive results for any of the tests: Hepatitis B Surface Antigen Qualitative Test, Hepatitis C Virus Antibody, Hepatitis C Virus Core Antigen, Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Test, and Syphilis Spirochete-Specific Antibody Test. 17. Acute illness or concomitant medication between the screening phase and the time of administration of the trial drug product. 18. Consumption of chocolate, any caffeinated or xanthine-rich foods or beverages in the 24 hours prior to taking the trial drug. 19. Have taken any alcohol-containing product within 24 hours prior to taking the test medication or a positive breath test for alcohol. 20. A positive urine drug screen or a history of substance abuse within the past five years. 21. The investigator considers the subject unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;vital signs;12 lead electrocardiogram;laboratory examination;adverse events; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan(Hang Zhou) Hospital
Outcome results
None listed