Epilepsy
Conditions
Interventions
1:Midazolam injection intravenous injection \ midazolam nasal spray \ midazolam injection buccal administration
2:Midazolam injection intravenous injection \ midazolam nasal spray \ midazolam injection buccal administration
3:Midazolam injection intravenous injection \ midazolam nasal spray \ midazolam injection buccal administration
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 18 years, both male and female; 2. The body weight of male volunteers >= 50.0 kg, female volunteers >= 45.0 kg, body mass index (BMI) between 19 and 26 kg / m2, including the critical value; 3. Volunteers who voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who have or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or can interfere with the test results Any other diseases; 2) A history of allergy to drugs, food or other substances; 3) Those with abnormal anatomical structure of the nasal cavity, those with damaged nasal cavity or oral mucosa, those with excessive secretions of the nasal cavity or oral mucosa, those with sensitive taste; 4) Patients with difficult airways, including patients with modified Mallampati grade III to IV, congenital large mouth and tongue, and poorly developed mandible; 5) Patients with glaucoma, especially patients with acute angle-closure glaucoma; 6) Those who have undergone surgery within 4 weeks before the trial, or plan to perform surgery during the study period; 7) Those who have taken any drugs or health products (including Chinese herbal medicines) within 14 days before the trial; 8) Have used any drug that inhibits or induces liver metabolism of the drug within 30 days before the test (eg, inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRIs Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 9) Those who took any clinical trial and took any clinical trial drugs within 3 months before the trial; 10) Those who donated blood or lost a large amount of blood (=200 mL), received blood transfusion or used blood products within 3 months before enrollment; 11) Women who are pregnant or breastfeeding, and those who cannot use one or more non-pharmacological contraceptive measures during the trial; 12) Those who have special requirements for diet and cannot follow the unified diet; 13) Drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 14) Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the test or who could not stop using any tobacco products during the test; 15) Alcoholics or frequent drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test Stop using any alcoholic products; 16) Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 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 , Physical examination, electrocardiogram, 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 the investigator believes it should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration of Midazolam; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical trial research center, Xiangya Third Hospital, Central South University
Outcome results
None listed