None listed
Conditions
Sponsors
Shanghai Institute of Materia Medica, CAS; Second Affilitated Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 35 years. 2. The weight of all subjects must be greater than 50 kg, and the body mass index should not exceed 15% of the ideal value. Body mass index = weight (kg)/height (m) squared (body mass index is between 19 and 24). 3. General physical examination, laboratory, physical and chemical examinations are all normal. 4. The subject agreed to inform them to eat food and medicine within 1 week. 5. According to GCP regulations, obtain informed consent and take the test voluntarily.
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, Guhong ingredients and product (including other drugs). 6. Subjects who took herbal medicines or food or beverage containing Honghua or aceglutamide. 7. Subjects who participated any other investigational drug study within four week prior to this study. 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. 9. Subjects with hemorrhagic tendency. 10. Menstrual, pregnant or breast-feeding women and women at childbearing age take oral contraceptive. 11. Subjects with abnormal vital signs (systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg, or heart rate 100 bpm). 12. 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. 13. 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. 14. Subjects with risk factors that possibly influence the absorption, disposition, excretion and metabolism. 15. Subjects who donate blood within three month prior to this study. 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;urine concentration; | — |
Countries
China
Contacts
Public ContactLi Chuan
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Outcome results
None listed