This product is a colloidal plasma volume substitute indicated for:(1) Treatment of relative or absolute hypovolemia and shock.(2) Prevention of hypotension:? Prevention of hypotension that may occur following spinal or epidural anesthesia
Conditions
Interventions
Group B (R-T sequence):The first cycle involved a single intravenous infusion of the reference formulation, succinyl gelatin injection, 500 ml: 20 g. The second cycle involved a single intravenous inf
Group A (T-R sequence):The first cycle involved a single intravenous infusion of the test formulation, succinyl gelatin injection, 500 ml: 20 g. The second cycle involved a single intravenous infusion
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Chinese adult subjects aged 18 to 60 years (inclusive), of either gender. 2.Male trial participants' weight should be >= 50.0 kg, and female trial participants' weight should be >= 45.0 kg. Their body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m^2, including the critical value; 3.Before the trial, they voluntarily sign the informed consent form and fully understand the trial content, process, and possible adverse reactions; 4.They can communicate well with the researchers and understand and comply with all the requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Those who participated in any drug clinical trial within 3 months before the first administration and used the trial drugs; 2.Those who had previously or currently suffered from any serious clinical diseases of the 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.), urinary reproductive system (such as renal insufficiency, renal damage, water/sodium retention, etc.), hematology (such as coagulation dysfunction), immunology, metabolic disorders (such as electrolyte imbalance diseases), and psychiatry, or any other diseases that could interfere with the test results; 3.Those who had symptoms such as nausea, vomiting, abdominal pain, fever, rash, shortness of breath, breathing difficulty, dizziness, headache, palpitation, chest discomfort within 14 days before the first administration, and the investigator considered them unsuitable for the trial; 4.Those who were allergic to any component of this product; or allergic to red meat (meat from mammals), internal organs; or allergic to galactose-alpha-1,3-galactose; or had cumulative two or more allergies to other drugs, foods, or the environment; or had a constitution that had previously experienced allergic symptoms such as rash, urticaria, hypersensitivity reaction, allergic-like reaction, anaphylactic shock, etc.; 5.Those who could not tolerate venipuncture or had a history of fainting during blood drawing, or had difficulty in blood collection; 6.Those who had undergone surgery within 4 weeks before the first administration; or those who planned to undergo surgery (including dental surgery or invasive dental intervention) during the study period until the last administration (including dental surgery or invasive dental intervention); 7.Those who had used any drugs with drug interactions with succinylcholine gel injection (such as corticosteroids, non-steroidal anti-inflammatory drugs, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors [ACEI], cyclosporine, tacrolimus or succinylcholine, cardiac glycosides, adrenocorticotropic hormone [ACTH], loop diuretics, etc.) within 30 days before the first administration, and the investigator judged them not suitable for the trial; 8.Those who had used any drugs or health supplements within 14 days before the first administration (including prescription drugs, over-the-counter drugs, vitamins, vaccines or Chinese herbal medicines, etc.); 9.Those who had donated blood or suffered significant blood loss (more than 400 ml) within 3 months before the first administration, or received blood transfusion or used blood products, or planned to donate blood or receive blood components during the trial period until the last administration; 10.Those who had a history of drug abuse, drug dependence, or had used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; 11.Those who were heavy smokers or had a daily smoking quantity of = 5 cigarettes within 3 months before the trial, or could not stop using any tobacco products during the trial; 12.Those who were heavy drinkers or had frequently consumed alcohol within 6 months before the trial, that is, consuming more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol liquor or 150 ml o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram Features;Vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed