None
Conditions
Interventions
Warfarin alone/combination group:Cycle I (Days D1-D9):
On the dosing day (Day D1), a single dose of warfarin (5 mg) was administered in the morning after an overnight fast, taken with 240 mL of water.
Danhong injection alone/combination group:Cycle I (Days D1-D2):
On Day D1, a single administration of Danhong injection is performed via intravenous drip. The Danhong injection (40 mL) is diluted by m
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants between the ages of 18 and 45 (inclusive). 2. Male participants should not be less than 50 kg and female participants should not be less than 45 kg, with a body mass index [BMI = body weight (kg)/height2 (m2)] within the range of 19 to 26 kg/m2 (including borderline values); 3. The participant is in good health without any cardiovascular, respiratory, renal, gastrointestinal, hepatic, metabolic, endocrine, immunological, neurological or psychiatric diseases or abnormalities of clinical significance; 4. Who has no pregnancy plans within 6 months and who agrees to use effective contraception during the trial and for 6 months after the last dose of study drug; 5. Participants who are able to communicate well with the investigator and who understand and comply with the requirements of this study and are able to complete the study in accordance with the trial protocol requirements; 6. Before the commencement of the trial, fully understand the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant , lactating women or women of childbearing age who are unable to use contraception as required and men who do not use contraception as required; 2. Participants who are allergic to the study drug and related excipients; 3. Participants who are regular users of sedative, sleeping or other addictive drugs; 4. Participants who have been substance abusers or screened positive for substance abuse within 12 months prior to dosing; 5. Participants who have smoked more than 5 cigarettes per day in the 3 months prior to the start of the trial or who are unable to stop using any tobacco-based products during the trial period 6. Participants who have regular alcohol consumption in the 6 months prior to the trial, i.e., consumption of more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or inability to abstain from alcohol for the duration of the trial, or a positive breath test result for alcohol; 7. Participants who have vaccination within 4 weeks prior to the first dose of study medication, use of any prescription medication, herbal supplements, and/or use of any over-the-counter (OTC) medication, nutritional supplements, vitamins within 2 weeks prior to the first dose of study medication; 8. Participants who have donated blood within the last 3 months prior to enrolment, or having lost more than 400 mL of blood for any other reason; 9. Participants who have participated in other clinical trials within the last 3 months; 10. Participants who are abnormal in vital signs, physical examination, laboratory examination, chest X-ray, 12-lead ECG, or any other item that is clinically significant in the judgement of the investigator; 11. Participants who are positive for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Antibody (HCV), Syphilis, or Human Immunodeficiency Virus (HIV); 12. Participants who have a positive pregnancy screening test result; 13. Participants who consume any beverage or food containing caffeine, such as coffee, tea, cola, chocolate, etc., 48 hours prior to the start of the study until the end of the trial; 14. Participants who have taken special diets (including dragon fruit, mango, grapefruit, purine-rich diets, etc.) or have had strenuous exercise, or other factors that affect the absorption, distribution, metabolism, excretion, etc. of the drug, from 2 weeks prior to the start of the trial until the end of the trial; 15. Participants who cannot tolerate venipuncture; 16. Participants who have a history of dysphagia or any intestinal disorder that interferes with drug absorption 17. Participants who are in the judgement of the investigator, are unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| concerntrations in plasma of warfarin;prothrombin time; | — |
Secondary
| Measure | Time frame |
|---|---|
| concerntrations in plasma of main ingredients in Danhong injection;thrombin time;activated partial thromboplastin time;fibrinogen;CYP2C9 genetic polymorphism testing;VKORC1 genetic polymorphism testing; | — |
Countries
China
Contacts
Public ContactMing Yang
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed