None listed
Conditions
Interventions
Group 1:subcutaneous injection of Ropivacaine hydrochloride injection
Group 2:subcutaneous injection of LL-50 injection
Group 3:transversus abdominis plane block of Ropivacaine hydrochloride injection
Group 4:transversus abdominis plane block of LL-50 injection
Group 5:subcutaneous injection of saline
Group 6:transversus abdominis plane block of saline
Sponsors
37 Guoxue Lane, Chengdu, Sichuan
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) healthy Chinese men and women aged 18= 55 with full civil capacity; 2) body weight =50 kg for men and =45 kg for women; 19=BMI=26 [Body Mass Index (BMI) = weight kg/(height m)^2]; 3) normal vital signs: systolic blood pressure =90 and < 140mmHg, diastolic blood pressure =60 and < 90mmHg; Heart rate =50 and =100 BPM; Oxygen saturation (SpO2) during air inhalation was =95%. Respiratory rate =8 and =25 breaths/min; The body temperature was =37.3 ° C and =36?; 4) laboratory tests [blood routine, blood biochemistry, coagulation function, urine routine, blood pregnancy (women of childbearing age)], 12-lead heart test Electrocardiogram and chest X-ray were normal or abnormal but of no clinical significance. 5) Able to fully understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete this trial, and signed informed consent Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1) have a history of severe narcotic allergy, allergic constitution, or known to have a history of allergy to any component of this product and its excipients; 2) Individuals with a history of primary diseases of important organs, such as the heart, liver, kidneys, or blood metabolism, a history of head trauma, illness or surgery, a history of mental and neurological disorders, a history of epilepsy, a history of clinically significant anesthesia accidents, a family history of genetic diseases such as malignant high fever, a history of peripheral nervous system diseases, a history of neuropathic pain, a history of glucose-6-phosphate dehydrogenase deficiency, and a history of porphyria; 3) severe infection, trauma, or major surgery within 4 weeks before screening; Or clinically significant (by investigator-judged), such as gastrointestinal disorders, infections (respiratory or central nervous system infections, etc.); 4) patients with drug abuse history or positive screening results; 5) there is damage, scar, infection, abnormal color or pigmentation of the skin at the intended administration site; The site (or innervation of the nerve) to be administered area) had sensory and motor abnormalities; 6) smokers who smoked =5 cigarettes per day in the 3 months before screening; 7) a positive breath test for alcohol or alcohol abuse in the past 3 months (drinking more than 14 units of alcohol per week: 1 unit = about 285mL of beer; or liquor about 25mL, or wine about 100mL); 8) have participated in any drug or medical device clinical trial within 3 months before screening, or have participated in 3 or more clinical trials within the past year those who are enrolled in drug clinical trials; 9) those who consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup =250mL) in the 3 months prior to screening; or intake of any food or beverage containing caffeine (e.g., coffee, strong tea, chocolate, Coke, etc.); 10) Prescription or over-the-counter medications (vitamins, diets) taken within 2 weeks or less than 5 half-lives (whichever is longer) prior to screening dietary supplements, traditional Chinese medicine preparations, etc.); 11) those who could not guarantee to avoid vigorous physical activity from 2 days before to 2 days after administration; 12) any marker of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV antibody), treponema pallidum antibody, or HIV antibody those who were screened positive; 13) expected to have surgery or hospitalization during the trial; 14) donated blood within 3 months before screening or lost more than 200mL of blood due to other reasons (excluding women's blood loss during menstrual period); 15) pregnant or lactating women; 2 weeks before screening until the end of the trial for male (or their partner) or female participants if they had a plan of pregnancy, sperm donation or egg donation within the first month of the study, and were unwilling to use a medically approved non-drug contraceptive measure (such as condom, complete abstinence, contraceptive ring, etc.) during the study; 16) other patients judged by the clinician to be ineligible for the trial (including but not limited to abnormal physical examination and pain sensitivity often, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| physical examination;vital signs ( heart rateblood pressurepulse oximetry);12 lead electrocardiogram;routine laboratory assessments (hematology, blood chemistry, immunology, and urinalysis) For women of childbearing potential, pregnancy testing( was conducted at screening and before study drug administration);Adverse events;serious Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to reach maximum plasma concentraion:Tmax;maximum concentration :Cmax;area under the plasma concentration-time curve from time 0 to 1 hour after study drug administration : AUC0-1h;area under the plasma concentration-time curve from time 0 to last collection time after study drug administration: AUC0-last;area under the plasma concentration-time curve extrapolated to infinity after drug administration :AUC0-inf;clearance rate:CLz/F;Vz/F;half-life:T1/2;Preliminary excretion evaluation in urine and feces;Sensory Testing; | — |
Countries
China
Contacts
Public ContactZhang Wensheng
West China Hospital, Sichuan University
Outcome results
None listed