CompletedPhase 1

Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

China68 participantsStarted 2023-12-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. healthy adult male and female subjects aged 18-45 years (inclusive);
✓. 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;
✓. 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

✕. if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful;
✕. potentially difficult airway;
✕. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
✕. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
✕. use of any prescribed medication within 14 days before dosing;
✕. use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;
✕. any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results;
✕. patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;

What they're measuring

Pharmacokinetic Parameter(ET-26/ etomidate acid)

Timeframe: 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.

Trial details

NCT IDNCT06822166

SponsorAhon Pharmaceutical Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-23

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