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Human Bioequivalence Test of Propofol Medium/Long Chain Fat Emulsion Injection

Human Bioequivalence Test of Propofol Medium/Long Chain Fat Emulsion Injection

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039805
Enrollment
Unknown
Registered
2020-11-10
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short-acting intravenous general anesthetics

Interventions

experimental group:T-R/R-T

Sponsors

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Chinese volunteers over 18 years old (including 18 years old), both male and female; 2) The weight of male volunteers is >= 50.0 kg, and the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is between 19 ~ 26 kg/m2, including the critical value; 3) Volunteers voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1) People who have previously or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results, Such as those with significant clinical significance of gallbladder disease, those with a history of tumors, those with any visual impairment caused by ocular vascular diseases, those with a history of severe migraine or headache, and those with coagulopathy in the past Or those with thromboembolic disease or a history of epilepsy; 2) Those who have previously or currently have airway diseases such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome, have had hereditary acute porphyria in the past, have had cardiovascular insufficiency, respiratory insufficiency and hypovolemia, Those who have had lipometabolism in the past or need to use fat emulsions with caution; 3) Those who have received surgery within 4 weeks before the test, or plan to perform surgery during the study period; 4) A history of allergies to drugs, foods (such as soybeans, peanuts, eggs and egg products, coconut oil, palm kernel oil, etc.) or other substances; to this product and auxiliary materials (refined soybean oil, medium-chain triglycerides, glycerin, Those who are allergic to any of the ingredients in lecithin, sodium oleate, or have a history of allergies to similar drugs, or have a history of allergic diseases (such as allergic reactions, angioedema, etc.) and the investigator believes that there is still clinical significance; 5) Any drugs that inhibit or induce liver metabolism of drugs have been used 30 days before the test (such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRIs) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Those who have used any drugs (including vitamins and Chinese herbal medicine) within 14 days before the test; 7) Those who have taken any clinical trial drugs or participated in any drug clinical trials within 3 months before the trial; 8) Those who donate blood or blood loss greater than 200 mL within 3 months before the test, or who plan to donate blood or blood components during the study period or within three months after the end of the study; 9) Volunteers (or their partners) have pregnancy plans, sperm and egg donation plans during the trial period to 3 months after the end of the trial, or cannot use one or more non-drug contraceptive measures (such as total abstinence, Contraceptive ring, partner ligation, etc.); 10) Pregnant or lactating women, or female volunteers with positive pregnancy test results; 11) Those who have special requirements for diet and cannot follow a unified diet; 12) Smokers or those who smoked more than 5 cigarettes per day 3 months before the test; 13) Alcoholics or frequent drinkers in the 6 months before the test, that is, drink more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% alcoholic spirits or 150 mL wine); 14) People who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 15) Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc

Design outcomes

Primary

MeasureTime frame
plasma concentration;AUC0-t, AUC0-8, Cmax, T1/2, MRT, CL, Vd, Css_min, Css_max, Css_av, DF;

Countries

China

Contacts

Public ContactYang Guoping

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

ygp9880@126.com+86 731-89918665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026