preoperative anxiety
Conditions
Interventions
Dose Group 1:25µg, two cycles, two crosses
Dose Group 2:50µg, 10 patients (5 men and 5 women) received the experimental drug, and 2 patients (1 man and 1 woman) received placebo
Dose Group 3:75µg, 10 patients (5 men and 5 women) received the experimental drug, and 2 patients (1 man and 1 woman) received placebo
Dose Group 4:100µg, 10 patients (5 men and 5 women) received the experimental drug, and 2 patients (1 man and 1 woman) received placebo
Sponsors
Xiangya Third Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects aged 18-45 years (including critical value), no gender limit; 2. Male volunteers should weigh at least 50.0 kg and female volunteers should weigh at least 45.0 kg. Body mass index (BMI) [= weight kg/(height m)^2] in the range of 19 to 26 (including the critical value); 3. Be able to read, understand and voluntarily sign the informed consent form (ICF), and complete the study according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Have been or are currently suffering from any clinically serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that can interfere with the test results; 2. Allergic to drugs, food or other substances; 3. Patients with abnormal nasal anatomy, damaged nasal mucosa, excessive secretion of nasal mucosa, and sensitive taste; 4. Patients who had surgery within 4 weeks prior to the trial or planned to have surgery during the study period; 5. Patients who have taken any medicine or health products (including Chinese herbs) within 14 days before the test; 6. Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 30 days prior to the test;Inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Participating in any clinical trial and taking any clinical trial drug within 3 months prior to the trial; 8. Patients who have donated blood or lost large amounts of blood (>=200 mL, excluding blood loss during menstrual period in women), received blood transfusions or used blood products within 3 months before the test; 9. Pregnant or lactating patients, and those who were unable to use one or more non-pharmaceutical contraceptive methods before the volunteers completed the trial; 10. Those who have special requirements for diet and cannot abide by uniform diet; 11. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day; 12. Those who consumed special diet (such as grapefruit and grapefruit-containing products, chocolate, any caffeinated or xanthine-rich foods (such as animal liver), or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc., within 48 hours before the trial; 13. Smokers or those who smoked more than 5 cigarettes a day in the 3 months before the trial or could not stop using any tobacco products before the completion of the trial; 14. Heavy drinkers or regular drinkers in the six months prior to the trial, i.e., those who drank more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or who could not stop using any alcoholic products before completing the trial; 15. Drug abusers or those who have used soft drugs (e.g., cannabis) in the three months prior to the test or hard drugs (e.g., cocaine, PCP, etc.) in the year prior to the test; 16. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive; 17. Patients with clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, B-ultrasound of liver, bile, spleen, pancreas and both kidneys, color ultrasound of heart and laboratory examination (subject to the judgment of clinical research doctors); 18. Patients with a history of needle sickness, carsickness, or who cannot tolerate venous puncture blood collection; 19. Patients who may not be able to complete the study for other reasons or who the researcher considers should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;physical examination;vital signs;laboratory test;12-lead ECG;adverse event; | — |
Countries
China
Contacts
Public ContactYang Guoping, Ouyang Wen
Outcome results
None listed