PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
Recruiting in Palo Alto (17 mi)
+2 other locations
YD
YD
MK
Overseen byMartin Kankam, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing two blood-thinning medications, Vicagrel and Clopidogrel, in healthy people who process these drugs differently. The goal is to see how well these medications work in preventing blood clots. Vicagrel is a new medication developed to address the limitations of Clopidogrel.
Research Team
YD
Yanhua Ding
Principal Investigator
Phase I Clinical Research Center of The First Hospital of Jilin University
YD
Youngjun David Kim, MD
Principal Investigator
Altasciences Clinical, Los Angeles
MK
Martin Kankam, MD
Principal Investigator
Altasciences, Kansas City
Eligibility Criteria
Inclusion Criteria
With normal or clinically insignificant abnormal results of physical examination and vital signs test;
Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
Able to complete the study in compliance with the protocol;
See 4 more
Exclusion Criteria
Positive results from a screen for urine drug test (Morphine, marijuana);
Subjects were vaccinated within 4 weeks prior to screening, or planned to be vaccinated during the trial;
Consumption of any special diet (such as grapefruit, pitaya, mango, pomelo, etc.) or subjects have engaged strenuous exercise or any other factors affecting drug absorption, distribution, metabolism and excretion within 14 days prior to receiving study drug;
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Treatment Details
Interventions
- Clopidogrel Tablets (Antiplatelet agent)
- Clopidogrel Tablets(PLAVIX ) (Antiplatelet agent)
- vicagrel Capsules (Antiplatelet agent)
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Ultra-rapid metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group II: Rapid metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group III: Poor metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group IV: Normal metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group V: Intermediate metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altasciences Clinical, Los AngelesLos Angeles, CA
Altasciences, Kansas CityKansas City, MO
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Who Is Running the Clinical Trial?
Jiangsu vcare pharmaceutical technology co., LTD
Lead Sponsor
Trials
20
Patients Recruited
3,000+