None listed
Conditions
Interventions
Test group 1:Single application of 0.32mg dexmedetomidine transdermal patch for 72 h
Test group 2:Single application of 0.66mg dexmedetomidine transdermal patch for 72 h
Test group 3:Single application of 1.06mg dexmedetomidine transdermal patch for 72 h
Test group 4:Single application of 1.6mg dexmedetomidine transdermal patch for 72 h
Test group5:Single application of 2.22mg dexmedetomidine transdermal patch for 72 h
Test group6:Single application of 2.89mg dexmedetomidine transdermal patch for 72 h
Test group7:Single application of 3.80mg dexmedetomidine transdermal patch for 72 h
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, Chinese healthy male and female volunteers; 2. Male volunteers should weigh no less than 50.0 kg, and female volunteers should weigh no less than 45.0 kg. Body mass index (BMI) [= weight kg/(height m)^2] is in the range of 19~26 (including 19 and 26); 3. Able to read, understand, and voluntarily sign the Informed Consent (ICF), and be able to complete the research in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergies to drugs, food or other substances; 2. Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study period; 3. Those who have taken any drugs or health products (including Chinese herbal medicine) within 14 days before the test; 4. Use of any drug that inhibits or induces liver metabolism of drugs within 30 days before the test (such as: inducersbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitorsSSRIs Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 5. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 6. Those who donated blood or lost a large amount of blood (>= 200 mL, excluding menstrual blood loss in women), received blood transfusion or used blood products within 3 months before the test; 7. Pregnant or lactating women, as well as volunteers who cannot use one or more non-drug contraceptive measures during the trial; 8. Those who have special requirements for diet and cannot comply with the unified diet; 9. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 10. Consumed a special diet (such as grapefruit and products containing grapefruit, chocolate, any caffeine-containing, or xanthine-rich food (such as animal liver)) or had strenuous exercise within 48 hours before the test drug, or other Factors that affect drug absorption, distribution, metabolism, and excretion; 11. Smokers or those who smoked more than 5 cigarettes per day in the first 3 months of the trial or those who could not stop using any tobacco products during the trial; 12. Alcoholics or frequent drinkers within 6 months before the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or unable to drink during the trial stop using any alcoholic products; 13. Drug abusers or those who have used soft drugs (such as marijuana) in the 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) in the 1 year before the test; 14. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive; 16) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormal physical examination, electrocardiogram, and laboratory tests have clinical significance (subject to the judgment of the clinical research doctor); 15. Abnormality of the outer skin of one or both upper arms and (or) skin diseases, including but not limited to: unhealed skin damage, dermatitis, burns, tattoos, scars, etc.; 16. Those with a history of needle sickness, motion sickness, or those who cannot tolerate venipuncture for blood collection; 17. The researchers believe that those who should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed