Atopic dermatitis
Conditions
Interventions
TR group:After fasting for at least 10 hours, apply 4g of the experimental formulation of solid boron ointment (specification: 30g/tube, 2%) in a fasting state, once per cycle, with a washout period o
RT group:After fasting for at least 10 hours, apply the reference preparation (brand name: Shutanming, specification: 30g/tube, 2%) in a fasting state, once per cycle, with a 7-day washing period, fol
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Chinese healthy volunteers, male and female (both sexes), aged over 18 years old (inclusive); 2.Body mass index (BMI) in the range of 19.0-26.0 kg/m^2[BMI= weight (kg)/height 2 (m^2)] (including critical value); 3.The participants (including their partners) had no plans to have children within 2 weeks before they were willing to self-medicate until 6 months after the last dose of study drug and voluntarily used an effective nonpharmacologic contraceptive method (see the Appendix to the protocol) and had no plans to donate sperm or eggs; 4.Informed consent was signed before screening, and patients fully understood the content, process and possible adverse reactions of the trial, and were able to complete the study in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Diseases with abnormal clinical manifestations that need to be excluded before screening, including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system, blood and lymphatic system, liver and kidney function, endocrine system, and immune system; 2. Vital signs, physical examination, clinical laboratory tests (blood routine, urine routine, blood biochemistry., infectious disease screening, pregnancy examination (only for women of childbearing age., and 12-lead electrocardiogram (ECG) showed clinically significant abnormalities; 3. If the subjects have angioedema, dermatitis or other skin diseases (especially if the skin is too dry and peelish, or if the skin has acne or acne., or if the investigators believe that the subjects have skin lesions or abnormalities that may affect the evaluation of the drug administration site, such as tattoos, birthmarks, urticaria, etc. 4. Those who had undergone surgery within 3 months before screening or planned to undergo surgery during the study, or those who had undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; 5. Allergic history to the test drugs, allergic constitution (two or more drugs and food allergy); 6. Those who had used any prescription drugs, over-the-counter drugs, health supplements, Chinese herbal medicines or vitamins within 2 weeks before screening; 7. Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.. or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion; 8. Subjects who consumed an average of more than 14 units of alcohol per week in the 3 months before screening, or who could not abstain from alcohol during the study; 9. Who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study; 10. Blood donation with blood components or massive blood loss (>=400mL. within 3 months before screening; 11. With a history of drug abuse or positive urine drug screening (morphine, THC, methamphetamine, dimethylenedioxyamphetamine, ketamine) in the past 5 years; 12. Taking any drugs that alter liver enzyme activity 28 days before screening; Or combined with the following inhibitors or inducers of P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; Or use drugs that act on blood vessels (vasoconstrictors or vasodilators. or regulate blood flow (e.g. nitroglycerin, antihypertensive drugs, antihistamines, non-steroidal anti-inflammatory drugs, aspirin, and over-the-counter cough/cold medicines containing antihistamines and/or phenylpropanolamine or phentolamine); 13. Participants who participated in other clinical trials within 3 months before screening or who did not participate in clinical trials themselves; 14. Were vaccinated within 1 month before screening or plan to be vaccinated during the study; 15. Patients who had been treated with topical dermatological drugs on their back skin within 28 days before screening; 16. Consuming excessive amounts of tea, coffee and/or caffeinated beverages (> 8 cups per day, 1 cup ˜250mL) during the 3 months before screening; 17. Those who have special requirements for diet and cannot accept a uniform diet; 18. The female subjects were lactating or pregnant at the time of screening or the trial; 19. Acute illness or new con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory indicators (blood routine, blood biochemistry, urine routine); | — |
Countries
China
Contacts
Public ContactGuiling Chen
Shulan (Hangzhou) Hospital
Outcome results
None listed