Relieve inflammation and itching symptoms of corticosteroid-responsive dermatitis
Conditions
Interventions
Sponsors
Clinical trial research center of Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged from 18 to 60 years old (including boundary value), both male and female; 2. The weight of male volunteers was more than or equal to 50.0 kg, and that of female volunteers was more than or equal to 45.0 kg. The body mass index (BMI) was between 19 and 28 kg / m2, including the critical value; 3. Volunteers who voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have suffered or are suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that can interfere with the test results; 2. Patients with allergic history of drugs, food or other substances; 3. Patients who had undergone surgery within 4 weeks before the trial or planned to undergo surgery during the study period; 4. Subjects who had taken any medicine or health products (including Chinese herbal medicine) within 14 days before the trial; 5. Any drugs (such as: inducer barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole) that inhibit or induce liver metabolism were used within 30 days before the trial; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Subjects who were treated with topical dermatology drugs within one month before the study; 7. Subjects who have been vaccinated or live attenuated vaccine within one month before the study, or who plan to be vaccinated during the study period; 8. Subjects who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 9. Subjects who donated blood or lost a large amount of blood (>= 200 ml, excluding female menstrual blood loss), received blood transfusion or used blood products within 3 months before inclusion; 10. Subjects with strong hair on both legs and arms; 11. Subjects of pregnant or lactating women, and subjects who cannot use one or more non drug contraceptives during the trial period; 12. Subjects with special dietary requirements could not follow the same diet; 13. Subjects who drank too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day; 14. Smokers or subjects who smoked more than 5 cigarettes per day three months before the experiment or who could not stop using any tobacco products during the experiment; 15. Alcoholics or regular drinkers within 6 months before the trial, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine) or could not stop using any alcoholic products during the trial; 16. Drug abusers or subjects who used soft drugs (such as marijuana) three months before the trial or hard drugs (such as cocaine, phencyclidine, etc.) one year before the trial; 17. Subjects with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; Heart rate 100 BPM) or abnormal physical examination, ECG and laboratory examination have clinical significance (subject to the judgment of clinical research doctors); 18. Subjects who may not be able to complete the study for other reasons or who the researcher thinks should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical Trial Research Center of Xiangya Third Hospital of Central South University
Outcome results
None listed