cerebral infarction
Conditions
Interventions
Healthy human subjects group A:50 mg Salvianolic Acids Injection in 0.9% sodium chloride injection 250 ml, intravenous drip, 1 time/day
Healthy human subjects group B:100mg salvianolic acids injection in 0.9% sodium chloride injection 250 ml, intravenous drip, 1 time/day
Healthy human subjects group C:200mg salvianolic acids injection in 0.9% sodium chloride injection 250 ml, intravenous drip, 1 time/day
Healthy human subjects group D:100mg salvianolic acids injection in 0.9% sodium chloride injection 250 ml, intravenous drip, 1 time/day, for 7 days
Patient with cerebral infarction group E:100mg salvianolic acids injection in 0.9% sodium chloride injection 250 ml, intravenous drip, 1 time/day
Sponsors
Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects, evenly divided between male and female, should be between 18 to 35 years old; 2. Patient with cerebral infarction, onset between 2 weeks to 2 months, men or women aged 18 to 70 years old; 3. Subjects signed Informed Consent Form prior to this study according to the GCP guidance.
Exclusion criteria
Exclusion criteria: 1. Healthy human subjects: (1) Subjects who had primary disease in key organs including heart, liver and kidneys, or had a history of gastrointestinal disease, metabolic disease or neurological disease; (2) Subjects who had mental or physical disability, or subjects with a history of lunacy; (3) Subjects with clinically significant abnormalities in physical examination, biochemistry, blood and urine analysis, electrocardiography, chest X-ray, or ultrasound screening; (4) Subjects with a history of drug dependence, drug abuse or alcoholism; (5) Subjects with physical allergy or known allergic to Danshen or Danshen gradient and product; (6) Subjects who took any Danshe related drug, food, health-care product, medicated diet within one week prior to this study; (7) Subjects who took any medication with known damaging effects on main organs within three months prior to this study, or took any over-the-counter or prescription drugs within two week prior to this study, or participated any other investigational drug study within four week prior to this study; (8) Subjects who had tendency of haemorrhage; (9) Menstrual, pregnant or breast-feeding women and women at childbearing age take oral contraceptive; (10) Subjects with abnormal vital signs (systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg, or heart rate 100 bpm); (11) Subjects who frequently took alcohol with six months (i.e., more than 14 Units of alcohol every week) or took more than one cigarette every day with three months prior to this study; (12). Subjects who took any soft drugs (e.g., marijuana) with three month or took any hard drugs (e.g., cocaine, phencyclidine, etc) with one year prior to this study; (13) Subjects with risk factors that possibly influence the absorption, disposition, excretion and metabolism; (14) Subjects who donate blood within three month prior to this study; (15) In the opinion of the investigator, subjects who are not suitable to participate in the study for whatever reasons must be excluded. 2. Patient with cerebral infarction: (1) Cerebral hemorrhage; (2) With Serious diseases such as liver, kidney, hematopoietic system, endocrine system disease, and osteoarthrosis, psychiatric illness; (3) Patients were allergic to drugs; (4) Pregnancy or lactation; (5) Patients are taking part in other clinical trial; (6) A history of cerebrovascular disease, has obvious sequelae and affects the evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;urinary concentration; | — |
Countries
China
Contacts
Public ContactHuang Yuhong
Outcome results
None listed