Adult intractable primary insomnia
Conditions
Interventions
Experimental group:Dexmedetomidine transdermal patch
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.After the subjects fully understand the test content, process, benefits and possible adverse reactions, they voluntarily participate in the test and sign the informed consent form; 2.Both men and women; 3.Aged 18 to 50 years; 4.The weight of men shall not be less than 50.0 kg and that of women shall not be less than 45.0 kg; Body mass index (BMI) = body weight (kg) / height^2(m^2) BMI is 19.0 ~ 26.0 kg / m^2 Within the range (including boundary value); 5.The results of physical examination were normal or abnormal, which had no clinical significance; 6.The results of vital signs were normal or abnormal, which had no clinical significance; 7.The results of laboratory examination (blood routine, urine routine, liver function, renal function, blood glucose, electrolyte and coagulation function) are normal or abnormal, and there is no clinical significance; 8.Female pregnancy test results were negative; 9.Serology (hepatitis B surface antigen, hepatitis C antibody, syphilis serum specific antibody, HIV antibody) results were normal. 10.The results of 12 lead ECG were normal; The results of chest X-ray examination were normal or abnormal, and there was no clinical significance; 11.The skin of arm and abdomen is intact without scar; 12.The subjects can communicate well with the researchers and complete the requirements of the researchers according to the research regulations.
Exclusion criteria
Exclusion criteria: 1.Patients have a history of drug allergy or are allergic to dexmedetomidine or to dexmedetomidine patch components; 2.Medical history of major skin diseases, such as atopic psoriasis, vitiligo, or disease reactions that are known to alter skin appearance or physiological condition (such as diabetes or porphyria); 3.A history of diseases that can seriously affect immunity (for example, primary or acquired immunodeficiency, such as HIV or AIDS); Allergic diseases, such as allergic reactions, asthma or systemic drug reactions; Tumors, such as lymphoma or leukemia; Rheumatoid arthritis; Or systemic lupus erythematosus); 4.History of major skin cancer, such as melanoma or squamous cell carcinoma; 5.The abdominal skin is densely hairy, and it is difficult to find a suitable patch; 6.Patients who participated in other clinical trials and used test drugs within 3 months before the screening period; 7.Drinking too much (more than 8 cups a day, 1 cup = 200ml) tea, coffee or caffeinated drinks for a long time (within 3 months before screening); Or ingesting any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first medication in the study; 8.Within 48 hours before the first medication in the study, those who ingest any beverage or food rich in xanthine or grapefruit ingredients or other beverages or foods that affect the absorption, distribution, metabolism and excretion of drugs; 9.Patients have used long-acting estrogen or progesterone injections or implants within 6 months before the test; Those who used short acting contraceptives within 30 days before the trial; 10.The investigator believes that the patient has any other conditions that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma dexmedetomidine concentration; | — |
Countries
China
Contacts
Public ContactWang Jin
Clinical Laboratory of Medicine, Chinese PLA General Hospital
Outcome results
None listed