pharmacokinetics and pharmacodynamics study in human
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) subjects identified as a EPHX1 A/A gene by genetic testing; 2) Male, aged 18 to 45 (including the boundary value); 3) Weight: body weight >=50kg, body mass index in the range of 19 ~ 26kg / m2 (including the boundary value); 4) General physical examination and laboratory or physical and chemical examinations are normal or abnormal but have no clinical significance; 5) All subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) those with coagulopathy and bleeding tendency, active ulcers, and trauma; 2) Vitamin K deficiency for various reasons; tissue or organ damage bleeding; 3) Allergic constitution or have a history of allergies to compound Danshen dropping pills, warfarin or other coumarin anticoagulants; 4) Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study period; 5) Those who have taken any drug within 3 days before the test (including Chinese herbal medicine), especially warfarin or Chinese medicine for promoting blood circulation and removing blood stasis; 6) Those who has used any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole;Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; 7) Those who participated in any drug clinical trial and used any test drug within 3 months before the test; 8) Those who donated blood within 3 months before the test (blood volume > 200ml); 9) Those who have special requirements for diet and cannot follow the unified diet; 10) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, electrocardiogram, laboratory examination and other abnormalities have clinical significance; 11) have a history of severe arrhythmia or prolonged QTc of ECG; 12) Subjects that may not be able to complete the study for other reasons or those who the researcher believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INR;Warfarin; | — |
Countries
China
Contacts
Public ContactYuhong Huang
Tianjin University of Chinese Medicine
Outcome results
None listed