respiratory tract
Conditions
Interventions
6:single injection
Sponsors
Phase I ClinicalTrial Laboratory of The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. male and female aged 18 to 45 years; 2. Male participants' weight = 50 kg; Female participants' weight = 45 kg; 3. the participants voluntarily signed ICF. BMI in 19~24 kg/m2
Exclusion criteria
Exclusion criteria: 1) (preliminary) before or currently suffering from circulation system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities of any clinical severe disease or any other disease which can interfere with the test results; 2) (preliminary) has a history of drug, food or other materials allergies; 3) (preliminary) with bleeding tendency, such as for minor collisions at ordinary times or cause bleeding or subcutaneous hemorrhage; 4) (preliminary) platelets less than 20% of the normal lower limit; 5) (preliminary) has a history of gastrointestinal bleeding; 6) (preliminary) nervous anxiety easily; 7) (preliminary) received within 4 weeks before surgery, or plan to have surgery during the study period; 8) (preliminary) within 14 days before taking any drugs (including Chinese herbal medicine); 9) (preliminary) used within 30 days before any inhibition or induction of liver of drug metabolism drugs (such as inducers, barbitone kind, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, large ring lactone class, nitro imidazoles, sedative hypnotics, verapamil, fluoroquinolone, antihistamines class); 10)(preliminary) within 3 months (preliminary) test before taking any drug clinical trials or clinical subjects took part in any drugs; 11) (preliminary) within 3 months prior to test blood donors; 12) (preliminary) during pregnancy and lactation women, or cannot be one or more precautions during test; 13) (preliminary) do you have any special diet requirements, cannot observe unified diet; 14) (preliminary) drink too much tea, coffee and/or caffeinated beverages every day (8 cups and 1 cup = 250 mL); 15) (preliminary) 3 months before the tobacco or test daily smoking more than 5 pieces; 16) (preliminary) within 6 months prior to alcoholics or test often drinkers, that drinking more than 14 units of alcohol a week (1 = 45 mL 360 mL beer or alcohol content of 40% spirits or 150 mL wine); 17) (preliminary) 3 months before the drug abusers or test used soft drugs (such as marijuana) or test a year before taking hard drugs (such as cocaine, benzene ring has piperidine, etc.); 18) vital signs is unusual ( 90 mmHg systolic, diastolic blood pressure 90 mmHg; heart rate 100 BPM) or physical examination, electrocardiogram (ecg) and laboratory abnormalities have clinical significance (with clinician determine accurate); 19) the subjects may be for other reasons that you can't accomplish or researchers think that the person should not be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Phase I Clinical Trial Laboratory of The Third Xiangya Hospital of Central South University
Outcome results
None listed