None
Conditions
Interventions
Pre-experimental group:Eight healthy volunteers were randomly assigned to T-R or R-T group 1:1. Volunteers were given a single intravenous infusion of 500 ml of the tested preparation (T, specificatio
Test group:Twenty healthy volunteers were randomly assigned to T-R or R-T group 1:1. Volunteers were given a single intravenous infusion of 500 ml of the tested preparation (T, specification: 500 ml:
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Chinese healthy adult volunteers aged 18 and above (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, with a body mass index (BMI) between 19.0 and 26.0 kg/m^2, including the critical value; 3.Voluntarily sign an informed consent form before the experiment, and fully understand the content, process, and possible adverse reactions of the experiment; 4.Those who are able to communicate well with researchers and understand and comply with the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Individuals who have participated in any drug clinical trials and used the investigational drug within 3 months prior to their first administration; 2.Previous or current patients with circulatory system (such as left or right ventricular dysfunction, hypertension, hypotension, tachycardia, arrhythmia, pulmonary edema, congestive heart failure, etc.), endocrine system, nervous system, digestive system, respiratory system (such as asthma, etc.), urogenital system (such as renal dysfunction, renal function injury, water/sodium retention, etc.), hematology (such as blood coagulation dysfunction, etc.), immunology, metabolic abnormalities (such as electrolyte disorders, etc.), psychiatry and other clinical serious diseases or any other diseases that can interfere with the test results; 3.Individuals who experience symptoms such as nausea, vomiting, abdominal pain, fever, rash, shortness of breath, difficulty breathing, dizziness, headache, palpitations, and chest discomfort within 14 days prior to the first administration, and who are deemed unsuitable for the trial by the researchers; 4.Individuals who are allergic to any component of this product; Or those who are allergic to red meat (mammalian meat.or internal organs; Or individuals allergic to galactose-alpha-1,3-galactose; Or those who have accumulated two or more allergies to other drugs, food, or the environment; Individuals with a constitution that has previously experienced allergic symptoms such as rash, urticaria, hypersensitivity reactions, allergic like reactions, and anaphylactic shock; 5.Those who cannot tolerate venous puncture or have a history of dizziness or needle fainting, or those who have difficulty collecting blood; 6.Having undergone surgical procedures within 4 weeks prior to the first administration of medication; Or those who plan to undergo surgical procedures (including dental surgery or invasive dental interventions.between the study period and 1 month after the last administration; 7.Individuals who have used any drugs that interact with succinylated gelatin electrolyte sodium acetate injection within 30 days prior to the first administration (such as corticosteroids, nonsteroidal anti-inflammatory drugs, potassium sparing diuretics, angiotensin-converting enzyme inhibitors [ACEI], cyclosporine, tacrolimus or succinylcholine, cardiac glycosides, adrenocorticotropic hormones [ACTH], loop diuretics, etc..and have been deemed unsuitable for the trial by the researchers; 8.Individuals who have used any medication or health supplements (including prescription drugs, over-the-counter drugs, vitamins, vaccines, or herbal medicines.within the 14 days prior to the first administration; 9.Individuals who donate blood or experience significant blood loss (>400 ml)within 3 months prior to the first administration, or who receive blood transfusions or use blood products, or who plan to donate blood or blood components between the trial period and 1 month after the last administration; 10.Individuals with a history of drug abuse, drug dependence, or who have used soft drugs (such as marijuana.or hard drugs (such as cocaine, phencyclidine, etc.)within the past year prior to the experiment; 11.Smokers or those who have smoked = 5 cigarettes per day within the 3 months prior to the trial, or those who cannot stop using any tobacco products during the trial period; 12.Alcoholics or frequent drinkers within the 6 months prior to the trial, who consume more than 14 units of a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed