None listed
Conditions
Interventions
Fasting test group:After fasting for at least 10 hours, take the test preparation (T) erdosteine capsules (Hetan) or the reference preparation (R) erdosteine capsules (ERDOTIN) with 240mL of warm wate
Postprandial test group:After fasting for at least 10 hours, start eating a high-fat, high-calorie meal 30 minutes before taking the medicine, and consume 100% of it within 30 minutes. Then take the t
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent; 2. Subjects aged over 18 years (including 18 years old), no gender limit; 3. Male weight >= 50.0kg, female weight >= 45.0kg; body mass index (BMI) within the range of 19.0-26.0kg/m^2 (including the critical value); 4. Those who are in good health and have no history of acute or chronic diseases such as the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system; 5. Subjects who have no reproductive plan from 2 weeks before screening to 3 months after the last dose and are guaranteed to take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to the components of this drug or analogs; 2. Those who have undergone surgery within 3 months before administration, or who plan to undergo surgery during the trial, and those who have undergone surgery that will affect the absorption, distribution, metabolism, and excretion of the drug; 3. Abnormalities in physical examination, vital signs examination, electrocardiogram and clinical laboratory examinations (with clinical significance as judged by clinicians); 4. The subject (female) is breastfeeding, or the pregnancy test result is positive; 5. Positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for HIV antibody and positive for syphilis; 6. Have taken other research drugs within 3 months before taking the study drug, or participated in other medical or drug clinical trials; 7. Those who donate blood or lose a large amount of blood (>200mL) within 3 months before taking the study drug, or plan to donate blood during the trial or within 1 month after the end of the trial; 8. Those who have the habit of smoking (at least 5 cigarettes per day) within 3 months before screening or who cannot stop using any tobacco products during the test; 9. Alcoholism within 3 months before screening (drinking more than 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine) or those who could not stop drinking any alcohol products or alcohol breath test results > 0mg/100mL during the test; 10. Those with positive drug abuse screening or a history of drug abuse within the past 1 year or drug use within 3 months before screening; 11. Any changes to the gastrointestinal environment within 30 days prior to taking the study drug (such as proton pump inhibitors tetolazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists ranitidine, cimetidine, famotidine, etc.; antacids sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc.; gastric mucosal protective agent sucralfate, etc.) or drugs for liver enzyme activity (such as inducersbarbiturates, carbamazepine, phenytoin, dexamethasone, etc.; inhibitorsSSRI antidepressants, ciprofloxacin, cimetidine, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, omeprazole, etc.); 12. Those who have taken any prescription drugs within 14 days before administration; 13. Those who have taken any over-the-counter medicines, health products or Chinese herbal medicines within 48 hours before administration; 14. Excessive consumption of foods that affect metabolism within 7 days before screening, including dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared therefrom; 15. Those who drink or take tea, coffee and/or caffeinated, alcoholic beverages and food (including chocolate, coffee, cola and any food rich in xanthine) 48 hours before taking the study drug; 16. Those who have eaten grapefruit (grapefruit) fruit or products containing grapefruit (grapefruit) ingredients within 72 hours before administration; 17. Those who have special requirements for diet and cannot comply with the unified diet; 18. Those who cannot tolerate venipuncture, have difficulty in collecting blood or have a history of fainting; 19. Those who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of erdosteine and its main active metabolite erdosteine thioacid; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Outcome results
None listed