epilepsy
Conditions
Interventions
A:T1-T2-T3
B:T2-T3-T1
C:T3-T1-T2
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged >= 18 years, both men and women; 2) The weight of male volunteers is >= 50.0 kg, the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is 19 ~ 26 kg/m2, with a critical value; 3) Volunteers voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Past or are currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary, hematology, immunology, psychiatry and metabolic abnormalities any clinically serious disease may interfere with the test knot. 2) A history of allergies to drugs, food or other substances; 3) Abnormal nasal anatomy, nasal or oral mucosal damage, nasal or oral mucosal secretions, taste sensitive person 4) Patients with difficult airways, including improved Mallampati class grade III~IV, patients with congenital uvula big mouth, jaw bone dysplasia, and etc.; 5) Patients with glaucoma, especially those with acute angle-closure glaucoma; 6) Surgery within 4 weeks prior to the trial, or scheduled for surgery during the study; 7) Anyone who took any medicine or health care products (including Chinese herbal medicines) within 14 days before the test; 8) Any drug that inhibits or induces liver metabolism of the drug within 30 days before the test (eg: inducer - Barbie, prostaglandin, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, anti-histamine); 9) Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; 10) A lot of blood or blood (>=200 mL), received a blood transfusion or use of blood products are within 3 months prior to enrollment; 11) Pregnant or lactating women, and volunteers who cannot use one or more non-pharmaceutical contraceptives during trial; 12) Those who have special requirements for diet and who cannot follow the unified diet; 13) Drink excessive tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 14) Smokers or more than 5 cigarettes per day for 3 months before the trial or can not stop using any tobacco during the trial period. 15) Alcoholics or those who regularly drink alcohol within 6 months before the test, that is, more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of alcohol with 40% alcohol or 150 mL of wine) or can not stop using any wine during the test. 16) Drug abusers or soft drugs (eg marijuana) used 3 months before the test or 1 year before the test (eg cocaine, phencyclidine, etc.); clinical study protocol comparative pharmacokinetic study of midazolam nasal spray. 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90) mmHg; heart rate/pulse 100 bpm) or airway assessment, nasal and oral examination, eye examination, physique examination, electrocardiogram, and laboratory examination abnormalities have clinical significance (subject to the judgment of the clinical research doctor); 18) Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Midazolam;Plasma concentration of 1'-hydroxy midazolam; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed