Healthy Volunteers
Conditions
Interventions
A:A 60-min infusion of 20mL QinKaiLing injection (diluted with 100 mL NaCl solution), intravenously administered. Plasma and urinary drug concentration were monitored within 24 h after the intravenous
Sponsors
Institute of Chinese Materia Medica, CACMS; Shanghai Institute of Materia Medica, CAS; Second Affilitated Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male human subjects should be 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 18.5–24.9); 3. Subjects with normal result of physical examination,laboratory tests,and biochemical tests; 4. 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 QingKaiLing gradient and product (including other drugs); 6. Subjects who took food or beverage affecting activity of drug enzyme, including alcohol, caffeine,orange, and so on; 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 with abnormal vital signs (systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg, or heart rate 100 bpm); 9. 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; 10. 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; 11. Subjects with risk factors that possibly influence the absorption, disposition, excretion and metabolism; 12. Subjects who donate blood within three month prior to this study; 13. 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; | — |
Countries
China
Contacts
Public ContactChuan Li
Outcome results
None listed