Substance Balance Trial of Methoxyethyl Etomidate Hydrochloride

Inclusion criteria

• healthy Chinese men;
• The age of signing the informed consent: 18-45 years old;
• Body mass index of 19-26 kg/m2, body weight of 60 kg±5kg;
• fully understand the purpose and requirements of the study, and voluntarily sign the informed consent;
• Able to communicate well with investigators and complete the trial according to the protocol.

Exclusion criteria

-

Auxiliary examination:

• Those with clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests, serum cortisol, 12-lead electrocardiogram, chest X-ray, digital anal examination, abdominal ultrasound ;
• potentially difficult airway ;
• resting corrected QT interval (QTcF) > 450 ms obtained by 12-lead electrocardiogram;
• hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG , or treponema pallidum antibody testing, human immunodeficiency virus antigen/antibody combination testing ;
• those who are not suitable for arterial blood sampling, such as Allen's test positive;

Medication history:

• patients who had taken any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or food supplements from 14 days before screening to the time of drug administration;
• Use of any drugs that inhibit or induce liver drug enzymes or affect the body's cortisol level between 30 days before screening and before drug administration;

History of disease and surgery:

• patients with a history of any clinically serious disease or disease or condition considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of cardiovascular, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases;
• patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
• patients with anesthetic accident history, malignant high fever history or related family history;
• previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome or symptoms of long QT syndrome and family history ;
• had a history or current respiratory disease, including respiratory insufficiency, obstructive lung disease, asthma, or bronchospasm requiring treatment within 3 months before screening; Or acute respiratory infection within one week before screening, with obvious symptoms such as fever, wheezing, nasal congestion and cough;
• patients who underwent major surgery within 6 months prior to screening or who had incompletely healed surgical incisions, including but not limited to any surgery with a significant risk of bleeding, prolonged general anesthesia, or open biopsy or significant traumatic injury;
• allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
• patients with hemorrhoids or perianal diseases with regular/ongoing hematochezia, gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease;

Living habits:

• habitual constipation or diarrhea;
• were heavy drinkers or regular drinkers in the 6 months before screening, i.e., drank more than 14 units of alcohol per week (1 unit =360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), had an alcohol breath test ≥20 mg/dl at screening, or were unable to abstain from alcohol during the trial;
• smoked more than 5 cigarettes per day or were habitual users of nicotine-containing products in the 3 months before screening, or were unable to quit during the trial;
• abusing drugs or using soft drugs 3 months before screening or hard drugs 1 year before screening; Or positive urine drug test during screening period;
• habitual drinkers of grapefruit juice or excessive tea, coffee and/or caffeinated beverages who were unable to abstain during the trial;
• with strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion;

Others:

• workers who are exposed to radioactive conditions for a long time, or have had significant radiation exposure within 1 year before screening, or participated in radiopharyngology labeling tests;
• patients with a history of syncope, or difficulty in blood collection, or can not tolerate venipuncture blood collection;
• those who had taken any investigational drug or used any investigational device within 3 months before screening;
• vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
• had plans to give birth or donate sperm within 1 year after signing the informed consent form, or did not agree to take strict contraceptive measures for the subjects and their spouses within 1 year after completing the study ;
• if they had lost blood or donated ≥400 mL within 3 months before screening, received a transfusion or blood component within 1 month, or were planning to donate blood during the trial;
• those who have special requirements for diet or cannot abide by the uniform diet; Or they refused to discontinue any beverage containing xanthine derivatives such as caffeine for 48 hours before drug administration until the end of the study; The subjects refused to stop eating animal offal, seafood, soy products and other foods with high purine content.
• had any other factors considered by the investigator to preclude participation in the study.