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Compensation: Varies

Number of Visits: Unknown

Duration: 31 days

128 Participants Needed

PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers

Recruiting at 2 trial locations

Overseen ByXiaojuan Lai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Smoking, Drug abuse, Bleeding disorders, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any prescription drugs, over-the-counter drugs, vitamins, or herbal medicines at least 14 days before starting the study medication.

What data supports the effectiveness of the drug Clopidogrel Tablets, Clopidogrel Tablets (PLAVIX), and vicagrel Capsules?

Clopidogrel, known as Plavix, is effective in preventing heart attacks and strokes by stopping blood clots from forming, as shown in several studies. It has been found to be more effective than aspirin for patients with certain heart conditions.¹ ² ³ ⁴ ⁵

What safety data exists for vicagrel and clopidogrel in humans?

Vicagrel, a drug similar to clopidogrel, has been tested in healthy people and found to be safe and well-tolerated, even at higher doses. Although some side effects were noted, none were serious, suggesting it is generally safe for human use.⁶ ⁷ ⁸ ⁹ ¹⁰

How is this drug different from other treatments for its condition?

Vicagrel is a new drug similar to clopidogrel, but it may offer different effects on platelet activity, which is important for preventing blood clots. It is being studied for its unique properties compared to clopidogrel, especially in how it is processed in the body and its impact on platelet reactivity.² ⁷ ¹¹ ¹² ¹³

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

Yanhua Ding

Principal Investigator

Phase I Clinical Research Center of The First Hospital of Jilin University

Youngjun David Kim, MD

Principal Investigator

Altasciences Clinical, Los Angeles

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;

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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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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 7-day cross-dosing of vicagrel and clopidogrel between two cycles

31 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Clopidogrel Tablets
Clopidogrel Tablets（PLAVIX ）
vicagrel Capsules

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Ultra-rapid metabolizers groupExperimental Treatment2 Interventions