None listed
Conditions
Interventions
0.04 mg/kg group:Eight subjects received the trial drug in the fasting state and 2 subjects received the placebo in the fasting state
Pre-test group:2 subjects received the test drug (0.04 mg/kg) in the fasting state, and 2 subjects received the active control drug in the fasting state
0.08 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
0.13 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
0.20 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
0.26 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
0.36 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
0.40 mg/kg group:Eight subjects received the test drug in the fasting state, 2 subjects received the placebo in the fasting state, and 2 subjects received the active control drug in the fasting state
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18 to 45 years (including the cutoff value) at the time of screening, no geder limit; 2. Body mass index (BMI) within the range of 19 to 26 kg/m^2; 3. After the subjects fully understand the purpose, content, process and possible risks of the trial, they voluntarily participate and sign the informed consent; 4. Be able to communicate well with the investigator, be willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate with the completion of the trial process.
Exclusion criteria
Exclusion criteria: 1. The investigator determines that the patient's current medical history and past history have a disease or dysfunction that affects the clinical trial, including but not limited to the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood and lymphatic system history of chronic or severe disease, mental illness; 2. Whole body physical examination, vital signs, blood routine, blood biochemistry, urine routine, coagulation function, whole chest radiograph, 12-lead electrocardiogram, abdominal B-ultrasound are abnormal and clinically significant; 3. Those who are known to be allergic to etomidate or other anesthetics, soybeans, peanuts, eggs or egg products, or those with allergic constitution (allergies to two or more drugs, the environment or food), or prone to rash, urticaria and other constitutions, or have a history of allergic diseases; 4. Those with a history of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident; 5. Those who have had difficulty in ventilation or suspected difficult airway or estimated difficulty in endotracheal intubation in the past (such as modified Mallampti score III-IV, congenital uvula, and mandibular dysplasia, etc.); 6. Those with past or current airway diseases such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome; 7. Those with a history of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 8. Fasting blood glucose 6.1mmol/L or serum potassium >5.3mmol/L; 9. Clinically significant ECG abnormalities found at screening, including QTcF >= 450 ms (men) or >= 470 ms (women); 10. Those who have a history of drug abuse, drug dependence, or drug abuse within 1 year before screening, or positive urine drug screening (morphine, methamphetamine, ketamine, THC, and MDMA); 11. History of alcohol abuse within 6 months prior to screening (i.e. drinking more than 14 standard units per week (1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine) or positive alcohol breath test (result > 0), or those who cannot abstain from alcohol during the test; 12. Those who have a positive result of the tobacco test, or who are addicted to smoking (smoking >=5 cigarettes per day) within 6 months before screening, or who are unable to quit smoking (including the use of nicotine chewing gum or transdermal nicotine patches) during the test; 13. Those who ingested caffeinated foods or beverages (such as coffee, strong tea, chocolate, caffeinated carbonated drinks, cola, etc.) within 48 hours before screening; 14. Those who have ingested any beverage or food rich in grapefruit within 48 hours before screening; 15. Those who have special requirements for food and cannot follow a unified diet or have difficulty swallowing; or those who are usually anorexia, dieting, or who have started a significantly abnormal diet (such as dieting, low sodium) within 4 weeks before screening; 16. Difficulty in collecting blood, unable to tolerate venipuncture and/or having a history of haemorrhage or needle halo; 17. Patients who are pregnant or breastfeeding during the screening period; and those who refuse to take effective non-drug contraceptive measures (such as abstinence, intrauterine device), or have sperm or egg donation plans throughout the study period and within 3 months afte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping, Ouyang Wen
Outcome results
None listed