drugset / Trial / NCT03306550

Mechanism of Drug-drug Interaction Between Salvianolate Injection and Aspirin

NCT03306550

RandomizedParallel-groupOpen-labelTreatment

Summary

The combination of anti-platelet medicine treatment and Chinese traditional medicine (TCM) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease. However, the material foundation, effective mechanism and drug-drug interaction is still not clear. In order to solve the puzzle of rational use of Joint application by TCM and Western Medicine(WM),investigators conduct a research on mechanism of drug-drug interaction between salvianolate injection and aspirin based on metabolic enzyme and PK-PD model. This clinical trial contain three groups, aspirin group, salvianolate injection group and combination (salvianolate injection+aspirin) group. Investigators collect blood samples at special time points during post-administration.Investigators have already find out the Salvianolate's pharmacokinetic characteristics in vivo and establish the biological sample-testing analysis method in previous research. Depending on these results, this clinical trial aim to explore the pharmacodynamics-pharmacokinetics(PK-PD) characteristics of combination with Salvianolate and aspirin through biomarkers, blood concentration. Finally clarify the TCM and WM material basis and mutual mechanism of drug interaction and guide reasonable clinical prescription.

Timeline

Start
2017-10-10
Primary completion
2018-04-10
Completion
2018-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg Oral
Subject salvianolate Unknown 200 mg