None listed
Conditions
Interventions
A:Eight male and six female subjects receive intravenous infusion of 250 mg Freeze-dried Xueshuantong for Injection (dissolved in 250 ml 5% glucose solution ) in 2.5 h. Plasma and urinary concentratio
B:Eight male and six female subjects receive intravenous infusion of 500 mg freeze-dried Xueshuantong for Injection (dissolved in 250 ml 5% glucose solution ) in 2.5 h. Plasma and urinary concentratio
C:Six male subjects receive intravenous infusion of 150 mg freeze-dried Xueshuantong for Injection (dissolved in 500 ml 5% glucose solution ) in 5 h. Plasma and urinary concentrations are monitored wi
D:Six male subjects receive intravenous infusion of 150 mg freeze-dried Xueshuantong for Injection (dissolved in 150 ml 5% glucose solution ) in 1.5 h. Plasma and urinary concentrations are monitored
E:Six male subjects receive intramuscular administration of 150 mg freeze-dried Xueshuantong for Injection (dissolved in 4 ml injectable water). Plasma and urinary concentrations are monitored within
F:Eight male subjects (could come from group B with at least 4 weeks washout period) take one pill of midazolam (7.5 mg, Roche, Dormicum) in the first day. Plas
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Sciences; Second Affiliated Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects, evenly divided between male and female, aged between 18 to 35 years old; 2. Subjects with body weight greater than 50 kg and body mass index (BMI) not exceeding the ideal value more than 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. People with primary disease of the heart, liver, kidney and other vital organs, history of gastrointestinal disease,history of metabolic disease,neurological diseases; 2. People 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. People with history of drug dependence, drug abuse or alcoholism; 5. People with physical allergy or known allergic to Sanqi (Panax notoginseng), Renshen (Panax ginseng), Xiyangshen (Panax quinquefolius) gradient and products; 6. People who took any saponin-contained [especially Gancao (Radix Glycyrrhizae), Huangqi (Radix astragali), Chaihu (Radix bupleuri), and Jiaogulan (Gynostemma pentaphyllum)] herb, food, health-care products, medicated diet within one week prior to this study; 7. People who participated in any drug clinical trial within 1 months before the test; 8. People who took any medication that is detrimental to the main organs within 3 months prior to this study, or took any over-the-counter or prescription drugs within 2 weeks prior to this study, or took this test medicine within 4 weeks prior to this study; 9. People who had tendency of haemorrhage; 10. Menstrual, pregnant or breast-feeding women and women at childbearing age take oral contraceptive; 11. People with abnormal vital signs(Systolic blood pressure90 mmHg; heart rate100 bpm); 12. People who were regular drinkers within 6 months before the test, drinking more than 14 units alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); people who sucked more than 1 cigarette per day within 3 months before the test; 13. People who took soft drugs such as marijuana within 3 months before the test or hard drugs such as cocaine, phencyclidine and so on within 1 year before the test; 14. Other factors that may affect drug absorption, disposition, excretion and metabolism; 15. People who donated blood within 3 months before the test; 16. People who are unsuitable for the test such as infirmity according to the judgment of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Urinary concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic and renal function; | — |
Countries
China
Contacts
Public ContactLi Chuan
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Outcome results
None listed