Healthy volunteer
Conditions
Interventions
Group A:Xuebijing injection, 50 ml, dilute with 100 mL Sodium Chloride Injection (totally 150 mL), intravenously infused. Plasma and urinary drug concentrations were monitored within 24 h after the in
Group B:Xuebijing injection 100 ml, dilute with 100 mL Sodium Chloride Injection (totally 200 mL), intravenously infused. Plasma and urinary drug concentration were monitored within 24 h after the int
Group C:Male subjects of Group A, Xuebijing injection, 50 ml once daily for 7 days, intravenously infused. Plasma and urinary drug concentrations were monitored within 24 h after single intravenous do
Group D:Xuebijing injection 100mL, dilute with 200 mL Sodium Chloride Injection (totally 300 mL), intravenously infused. Plasma and urinary drug concentration were monitored within 24 h after the intr
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Sciences; Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects, evenly devided between male and female, should be between 18 to 35 years old, with age difference of the same batch of subjects less than 10 years old; 2. Subjects with body weight greater than 50 kg and body mass index (BMI) not exceeding the ideal value of 15%. BMI=body weight in kg/(height in m)2 (the ideal value 19–24); 3. Subjects with normal result of physical examination, laboratory tests,and biochemical tests; 4. Subjects willing to impart the food and drugs ingested within one week; 5. Subjects signed Informed Consent Form prior to this study according to the GCP guidance.
Exclusion criteria
Exclusion criteria: 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 Honghua, Chishao, Danshen, Chuanxiong and Danggui, or the gradients and products of these herbs; 6. Subjects who took any Honghua, Chishao, Danshen, Chuanxiong or Danggui-related drug, food, health-care product, medicated diet within one week prior to this study; 7. Subjects who took any falavonol-enriched drinks, food, or drugs that contained apple, oion, tea, broccoli, cherry, strawberry, or ginkgo biloba before the study day; 8. 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; 9. Subjects who had tendency of haemorrhage; 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. Menstrual, pregnant or breast-feeding women and women at childbearing age take oral contraceptive; 16. In the opinion of the investigator, subjects who are not suitable to participate in the study for whatever reasons must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Urinary concentration;Physical examination;Biochemical test; | — |
Countries
China
Contacts
Public ContactChuan Li
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Outcome results
None listed