Atopic dermatitis
Conditions
Interventions
Group TR:In the first cycle, the subject applied the test preparation on an empty stomach
The second cycle of cross administration after 4 days
Group RT:In the first cycle, the subject applied the reference preparation on an empty stomach
Sponsors
Shulan(HangZhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent before the test and fully understand the test contents and possible adverse reactions; 2) Be able to complete the research according to the requirements of the test scheme; 3) Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration. See Appendix 5 for specific contraceptive measures; 4) Male and female subjects aged 18 ~ 50 years (including 18 years old and 50 years old); 5) The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg. The body mass index [BMI= weight (kg)/height 2 (m2)] is in the range of 19.0 ~ 28.0 kg/m2 (including critical value); 6) Physical examination of normal or abnormal vital signs has no clinical significance
Exclusion criteria
Exclusion criteria: 1) Screening those who smoke more than 5 cigarettes per day in the first 3 months or cannot quit smoking during the trial period; 2) Allergic constitution with allergic history to test drugs (allergic to two or more drugs and food); 3) A history of drug abuse and/or alcoholism (drinking more than 14 units of alcohol per week: 1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, or those who can't guarantee to give up drinking during the test or have a positive alcohol breath test at the time of screening); 4) Those who donated blood or lost a lot of blood (= 400 mL) within 3 months before screening; 5) Diseases at any risk, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 6) Any drug that alters liver enzyme activity was taken 28 days before screening; Or have used drugs that act on blood vessels (vasoconstrictors or vasodilators) or regulate blood flow (such as antihypertensive drugs, antihistamines, non-steroidal anti-inflammatory drugs, aspirin and over-the-counter cough/cold drugs containing antihistamines and/or phenylpropanolamine or phentolamine); 7) Any prescription drugs, over-the-counter Chinese herbal medicines or health products were used within 14 days before screening; 8) Those who have taken special diet (including dragon fruit, mango and grapefruit, etc.) or have exercise or other factors affecting drug absorption, distribution and metabolism within 2 weeks before screening; 9) There have been significant changes in diet or exercise habits recently; 10) Have used research drugs or participated in drug clinical trials within 3 months before screening; 11) People with angioedema dermatitis or other skin diseases or researchers believe that the subjects have skin injuries or abnormalities that may affect the evaluation of the administration site, such as tattoos, birthmarks and urticaria; 12) Those who have been treated with external dermatological drugs for their back skin within 28 days before screening; 13) The skin is too dry and peeling, and the skin has acne and acne; 14) Clinical laboratory examination or 12-lead electrocardiogram abnormality has clinical significance; 15) Female subjects are in lactation or pregnancy or positive blood pregnancy test during screening period or test; 16) Within 12 months before screening, there are known serious diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, tumor, lung immune spirit or cardiovascular and cerebrovascular diseases) that researchers think have clinical significance or affect the study; 17) When screening, there are one or more positive specific antibodies for combined detection of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen and human immunodeficiency virus antigen and antibody; 18) Acute disease occurs at the pre-study screening stage or before the study; 19) Chocolate, any food or beverage containing caffeine or xanthine within 24 hours prior to the use of the study drug; 20) Have taken any alcoholic products within 24 hours before the use study; 21) Those who are positive for alcohol and drug screening or have a history of drug abuse in the past five years or have used drugs three months before the test; 22) The researcher thought that the subjects were unfit to participate in the experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Concentration; | — |
Countries
China
Contacts
Public ContactChen GuiLing
Shulan(HangZhou) Hospital
Outcome results
None listed