seizures
Conditions
Interventions
Group A:In the first cycle, Group A was given subject formulation 1 (T1)
4 days after washing, in the second cycle, Group A was given the reference formulation
4 days after washing, in the third cycle, Group A was given subject formulation 2 (T2)
and 4 days after washing, in the fourth cycle, Group A was given the reference formulation.
Group B:In the first cycle, Group B was given the reference preparation
4 days after washing, in the second cycle, Group B was given subject preparation 2 (T2)
4 days after washing, in the third cycle, Group B was given the reference preparation
4 days after washing, in the fourth cycle, Group B was given subject preparation 1 (T1).
Group C:In the first cycle, Group C was given subject formulation 2 (T2)
after 4 days of washing, in the second cycle, Group C was given the reference formulation
after 4 days of washing, in the third cycle, Group C was given subject formulation 1 (T1)
after 4 days of washing, in the fourth cycle, Group C was given the reference formulation.
Group D:In the first cycle, Group D was given the reference formulation
4 days after washing, in the second cycle, Group D was given subject formulation 1 (T1)
4 days after washing, in the third cycle, Group D was given the reference formulation
and 4 days after washing, in the fourth cycle, Group D was given subject formulation 2 (T2).
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Age = 18 years, both male and female; 2) Male volunteers weighing =50.0 kg and female volunteers weighing =45.0 kg, with body mass index (BMI) between 19 ~ 26 kg/m2 with a BMI between 19 and 26 kg/m2 , including the threshold value; 3) Volunteers voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Volunteers meeting one or more of the following criteria will be excluded: 1) Persons with a pre-existing or current history of any clinically serious disease of the circulatory, endocrine, neurological, digestive, respiratory (snoring, stenosis or blockage of any anatomical part of the upper airway), genitourinary, hematologic, immunologic, psychiatric, and metabolic abnormalities or any other disease capable of interfering with the results of the test; 2) Persons who are allergic to midazolam and any of its excipients, or to two or more drugs (or foods); 3) who have undergone surgical procedures within 4 weeks prior to the trial or who plan to undergo surgical procedures during the study; 4) who have taken any medication or health supplement (including herbal remedies) within 14 days prior to the trial; 5) Use of any drug that interacts with midazolam within 4 weeks prior to screening (e.g., CYP3A4 inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; CYP3A4 inhibitors-SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, verapamil, chloroquinoids, antihistamines). (chloroquinolones, antihistamines); 6) Participating in any clinical trial and taking any clinical trial drug within 3 months prior to the trial; 7) those who have donated blood or lost a significant amount of blood (=200 mL, excluding blood loss during menstruation in women), received a blood transfusion, or used blood products within 3 months prior to enrollment; 8) women who are pregnant or breastfeeding, and those who are unable to use one or more non-pharmacological contraceptives during the volunteer trial; 9) Those who have special dietary requirements and are unable to comply with a uniform diet; 10) Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day; 11) smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to the trial or who were unable to stop using any tobacco products during the trial; 12) Positive pre-study first dose alcohol breath test, alcohol abusers or those who had consumed alcohol regularly in the 6 months prior to the trial, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or those who were unable to discontinue the use of any alcohol-containing product for the duration of the trial; 13) Substance abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to the trial or hard drugs (e.g., cocaine, phencyclidine, etc.) in the year prior to the trial; 14) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm; respiration 20 respirations/minute) or those with abnormalities of clinical significance in the physical examination, electrocardiogram, chest X-ray, or laboratory tests (based on the judgment of the clinical research physician); 15) Those with abnormal nasal anatomy, those with damaged nasal or oral mucosa, those with excessive nasal or oral mucosal secretions, and those with sensitive sense of taste; 16) patients with difficult airways, including patients with modified Mallampati class III-IV, patients with congenital micrognathia and mandibular dysplasia; 17) Patients with glaucoma; 18) Persons with acute or chronic nasal symptoms, nasal polyps, deviated septum, intol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;Laboratory tests;physical examination;electrocardiogram (ECG);AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;T1/2z;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Saiying Yang
Xiangya Hospital of Central South University
Outcome results
None listed