Central nervous system injury
Conditions
Interventions
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged 18-45 (including boundary values), both male and female; 2) Weight 50-80kg (including boundary value), body mass index (BMI) between 19~26kg/m2 (including boundary value); 3) Subjects voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who have a history of 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 or physiological conditions that can interfere with the test results; 2) With a history of autoimmune diseases, or with spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome); 3) There is a history of allergy to test drugs (monosialotetrahexose ganglioside sodium or any of its excipients), food or other substances; 4) HIV-Ab, HBsAg, HCV-Ab or syphilis serological test positive during screening; 5) Those who have received surgery within 4 weeks before the trial, or plan to perform surgery during the study period; 6) Those who have taken any medicines or health products (including Chinese herbal medicine) within 14 days before the test; 7) Participate in any clinical trial and take any clinical trial drugs within 3 months before the trial; 8) Those who donated blood or lost a lot of blood (>=200 mL), received blood transfusion or used blood products within 3 months before enrollment; 9) Those who have special requirements for diet and cannot follow a unified diet; 10) People who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 11) Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the test or who cannot stop using any tobacco products during the test; 12) Positive alcohol breath test during the screening period, alcoholics or frequent drinkers in the 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or spirits) 150 mL wine) or those who cannot stop using any alcoholic products during the test; 13) 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.) 1 year before the test; 14) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse 100 bpm, breathing 20 breaths/min), Patients with abnormal liver function, or abnormal physical examination, electrocardiogram, and other laboratory tests have clinical significance (subject to the judgment of the clinical research doctor); 15) Severe bleeding factors known to affect venous blood collection; 16) A history of mental illness confirmed by consultation; 17) Women who are pregnant or breastfeeding, have a pregnancy plan during the test, are unwilling to take effective contraceptive measures during the test and within 6 months after the end of the test; 18) Subjects may not be able to complete the study due to other reasons or the investigator thinks they should not be included.
Design outcomes
Primary
| Measure | Time 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
Outcome results
None listed