None listed
Conditions
Interventions
D:150 µg nasal spray/placebo single dose
E:200 µg nasal spray/placebo single dose
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, male and female; 2. Weight of male volunteers >=50.0 kg and female volunteers >= 45.0kg; Body mass index (BMI) ranged from 19.0 to 26.0 kg/m2 (BMI= weight [kg]/ height 2[m2]), including the boundary value. 3. The volunteers voluntarily signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have had or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other disease that can interfere with the test results; 2. A history of drug, food or allergy to experimental or similar drugs; 3. Screening those who had surgery within the previous month or planned surgery during the study period; 4. Any medication or health care product (including Chinese herbal medicine) taken within 14 days prior to administration; 5. Any drugs that inhibit or induce drug metabolism in the liver (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) were administered within 30 days prior to administration;Inhibitors - ssris antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); Screening people who had participated in any clinical trial of any drug and had used any experimental drug within the first 3 months; 6. Those who donated blood or lost a lot of blood (>=200 mL) within the first 3 months, received blood transfusion or used blood products were screened; 7. Pregnant or lactating women and volunteers who are unable to use one or more non-drug contraceptives for 90 days from the end of the trial; 8. Those who have special requirements on diet and cannot follow a uniform diet; 9. Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL); 10. Screening people who smoked more than 5 cigarettes per day in the first 3 months or could not stop using any tobacco products during the trial;Regular drinkers during the first 6 months of screening, i.e., those who consumed more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with a 40% alcohol content or 150 mL wine) or who could not stop using any alcoholic products during the trial; 11. Drug abusers or those who have used soft drugs (e.g. marijuana) within 3 months before screening or hard drugs (e.g. cocaine, benzodiazepine, etc.) within 1 year; 12. Inadaptable to nasal spray administration or unwilling to accept nasal administration; 13. Patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM) or physical examination, nasal examination, electrocardiogram, blood oxygen saturation, laboratory examination and other abnormalities have clinical significance (subject to the judgment of the clinician); 14. Volunteers who may have been unable to complete the study for other reasons or who should not be included in the study in the researcher's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of permalidomide; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed