Study for pharmacokinetics and pharmacodynamics between compound Danshen dripping pills and warfarin in microsomal epoxide hydrolase gene A/A (EPHX1 A/A) huma

Phase 1

• Conditions: pharmacokinetics and pharmacodynamics study in human

• Registration Number: ITMCTR1900002446
• Lead Sponsor: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

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

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 <90 mmHg or >140 mmHg, diastolic blood pressure <60 mmHg or >90 mmHg; heart rate <60 bpm or >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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
INR;Warfarin;