Interaction Drug Food
Conditions
Brief summary
Sixty-eight healthy subjects were divided into three sequences: A, B and C. The effects of CYP2C19 inhibitor fluconazole and inducer rifampicin on ET-26-HCl injection were evaluated, and the effects of ET-26-HCl injection on pharmacokinetics of omeprazole and midazolam were evaluated.
Interventions
DRUGrifampicin
rifampicin capsule，600 mg
DRUGFluconazole
Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses
DRUGOmeprazole
Omeprazole enteric-coated capsules: 20 mg
DRUGmidazolam
midazolam injection 0.05 mg/kg was administered intravenously
DRUGET-26
the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds
Sponsors
Ahon Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. healthy adult male and female subjects aged 18-45 years (inclusive); 2. Body weight: body mass index (BMI) between 18.0 and 30.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects; 3. The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.
Exclusion criteria
\- Auxiliary examination: 1. if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful; 2. potentially difficult airway; 3. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive; Medication history: 4. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening; 5. use of any prescribed medication within 14 days before dosing; 6. use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration; History of disease and surgery: 7. any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results; 8. patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders; 9. a history of severe cardiovascular disease, including but not limited to a history of organic heart disease, such as heart failure, myocardial infarction, angina, malignant arrhythmia, such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome, or symptoms of long QT syndrome and family history; 10. underwent any surgery within 6 months before screening; 11. allergic constitution; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients; Living habits: 12. heavy drinking or regular drinking in the 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test at baseline; 13. smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study; 14. had a history of drug abuse or drug abuse within 3 months before screening; Or the baseline urine drug test was positive; 15. habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages and inability to quit during the trial; Others: 16. those who have difficulty in blood collection, can not tolerate venipuncture or arterial blood collection; 17. participated in any other clinical trial within 3 months before screening; 18. vaccinated within 1 month before screening or planned to be vaccinated during the trial period; 19. pregnant or lactating women; 20. childbearing or sperm donation plan during the trial and half a year after the completion of the trial, or do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and half a year after the completion of the trial; 21. had blood loss or donation \>400 mL within 3 months before screening, or received blood transfusion within 1 month; 22. subjects with any factors considered by the investigator to be ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter(ET-26/ etomidate acid) | within 1 hour before and 24 hours after the end of ET-26-HCl.from 1 hour before administration of omeprazole enteric-coated capsules until 24 hours after the end of administration. | Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified observer's assessment of alert（MOAA/S） score | up to 10 minutes after drug administration. | The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness. |
| bispectral index | up to 10 minutes after drug administration. | BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition. |
| Eyelash reflex | up to 2 minutes after drug administration. | Gently touching the subject's eyelashes with a cotton swab can cause the subject to blink, that is, there is an eyelash reflex. When the eyelash reflex disappears, the patient has entered a state of anesthesia |
Countries
China
Outcome results
None listed