Can relieve inflammation and itching symptoms of corticosteroid-responsive dermatitis
Conditions
Interventions
Initial dose duration-effect study group:Sequentially administer the reference preparation at multiple pre-set time points within the same study day
Bioequivalence study group:Single administration of test product and reference product within the same study day
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chinese healthy volunteers between the ages of 18 and 60 (including boundary values), both male and female; 2.Body mass index (BMI) is between 19 ~ 28 kg/m2, including a critical value; 3.Subjects who can exhibit sufficient vasoconstriction with external corticosteroids are called "responders"; 4.Have written informed consent; 5.Voluntarily comply with research regulations.
Exclusion criteria
Exclusion criteria: 1. A history of allergies to drugs, food or other substances; 2. Those who have received surgery within 4 weeks before the test, or plan to perform surgery during the study period; 3. Participants in clinical trials of any drug or medical device within 1 month before the trial; 4. Those who have used topical dermatological drugs on the ventral skin of the forearm within 1 month before the test; 5. Those who have used drugs that act on blood vessels (vasoconstrictors or vasodilators) or regulate blood flow (such as nitroglycerin, antihypertensive drugs, antihistamines, non-steroids) within 1 month before the test Anti-inflammatory drugs, aspirin, and over-the-counter cough/cold medicines containing antihistamines and/or phenylpropanolamine or phentolamine); 6. Those who have received vaccines or live attenuated vaccines within 1 month before the study, or plan to be vaccinated during the study period; 7. Those who have had dermatitis or other skin diseases in the past; 8. Those who have obvious differences in the skin color of the arms; 9. The skin is too dry and peeling; 10. People with skin scratches; 11. Those with strong hair on the ventral side of the forearm; 12. Women who are pregnant or breastfeeding, and those whose subjects cannot use one or more non-drug contraceptive measures during the test period; 13. Those who have special requirements for diet and cannot follow a unified diet; 14. People who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 15. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the test or who cannot stop using any tobacco products during the test; 16. Alcoholics or those who drink regularly within 6 months before the test, that is, drink more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% alcoholic spirits or 150 mL wine) or cannot during the test Stop using any alcohol-containing products; 17. The subject may not be able to complete the study due to other reasons or the investigator believes that it should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin color;ED50; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed