Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

Ahon Pharma

Status and phase: Completed; Phase 1

Conditions: Interaction Drug Food

Treatments: Drug: ET-26; Drug: midazolam; Drug: rifampicin; Drug: Fluconazole; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT06822166

ET-26-HCL-CP-006

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Sequence A

Experimental group

Description:

rifampicin +ET-26

Treatment:

Drug: rifampicin

Drug: ET-26

Sequence B

Experimental group

Description:

Fluconazole+ET-26

Treatment:

Drug: Fluconazole

Drug: ET-26

Sequence C

Experimental group

Description:

Omeprazole enteric-coated capsules+midazolam+ET-26

Treatment:

Drug: Omeprazole

Drug: midazolam

Drug: ET-26