Reflux esophagitis
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gender: Healthy male or female subjects; 2. Age: 18 years old and above (including 18 years old); 3. Weight: Male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be within the range of 19.0 to 26.0 kg/m2 (including boundary values); 4. Those who voluntarily participate and sign an informed consent form; The process of obtaining informed consent forms complies with GCP; 5. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who have abnormalities in vital signs, physical examination, blood routine, blood biochemistry, coagulation test, urine routine, 12 lead electrocardiogram, female blood pregnancy, and preoperative four tests and have been determined by the researcher to have clinical significance; 2. Individuals with a history of chronic or serious diseases such as liver, kidney, digestive tract, endocrine system, cardiovascular and cerebrovascular system, nervous system, metabolic system, blood and lymphatic system, eye (such as glaucoma), gastrointestinal system (such as pyloric duodenal obstruction), respiratory system, and autoimmune system, or existing diseases of the aforementioned systems, and those deemed unsuitable for enrollment by the researcher; 3. Subjects with gastric acid related diseases (such as symptomatic gastroesophageal reflux disease, erosive esophagitis, gastric ulcers, duodenal ulcers, indigestion, etc.) within the past 6 months; 4. Individuals with a history of mental illness, drug abuse, or drug dependence; 5. Those who have special dietary requirements and cannot follow a unified diet; Or those with swallowing difficulties; 6. Those who have accumulated two or more allergies to other drugs, food, or the environment; Or those who have a history of allergies to any ingredients in voronorgestrel and its excipients; 7. Those who have used any drugs that interact with vorolaxen within the first 30 days of screening (such as CYP3A4 or P-gp inhibitors ketoconazole, itraconazole, clarithromycin, erythromycin, fluconazole, azanavir, indinavir, naphazolone, narfenavir, ritonavir, saquinavir, telithromycin, voriconazole, etc.; CYP3A4 inducers dexamethasone, phenytoin, carbamazepine, rifampicin, rifampicin, rifampicin, rifampicin, phenobarbital, St. John's grass, etc.); Or screen those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within the past 14 days; 8. Screening for individuals who have consumed excessive amounts (8 or more cups per day, 1 cup=250 mL) of tea, coffee, or caffeinated beverages within the first 3 months; Take tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before administration; 9. Screening for individuals who consume a large amount of grapefruit rich beverages or foods within the first 14 days (such as grapefruit, grapefruit juice, grapefruit jam, etc.); Individuals who have consumed any beverage or food rich in grapefruit (grapefruit) within 48 hours prior to administration; 10. Difficulty in blood collection or inability to tolerate venous indwelling needle blood collection; Individuals with a history of fainting needles or blood; 11. Screening for individuals who have consumed an average of more than 14 standard units of alcohol per week within the first three months (1 standard unit containing 14 g of alcohol, such as 360 mL of beer, 45 mL of 40% alcohol or 150 mL of wine); Or those who do not agree to abstain from alcohol during the period from the screening date to the end of the experiment; 12. Those who smoke an average of 5 cigarettes per day or more in the first 3 months of screening, or those who do not agree to a smoking ban from the screening date to the end of the experiment; 13. Screening for individuals who have participated in other clinical trials within the first three months; 14. Screening for individuals with a history of blood donation or significant bleeding (>400 mL) within t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z ;Eliminating terminal half-life; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed