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

NCT05162053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-11-03

No results posted yet for this study

Summary

This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

vicagrel Capsules

Oral administration for 7 days under fasting

DRUG

Clopidogrel Tablets

Oral administration for 7 days under fasting

Sponsors & Collaborators

  • Jiangsu vcare pharmaceutical technology co., LTD

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding · Phase I Clinical Research Center of The First Hospital of Jilin University

  • Youngjun David Kim, MD · Altasciences Clinical, Los Angeles

  • Martin Kankam, MD · Altasciences, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-11-03
Completion
2022-11-03
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162053 on ClinicalTrials.gov