Pharmacokinetic/Pharmacodynamic Study of Vicagrel Capsules and Clopidogrel Tablets in Healthy CYP2C19 Normal Metabolizers

NCT07067775 | Completed Phase 1

• 1 other identifier: VCP1-I-09
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）

  Day1-Day10

• maximum plasma concentration (Cmax)

  Day1-Day10

Study Arms (2)

Vicagrel Capsules

EXPERIMENTAL

Drug: Vicagrel Capsules

Clopidogrel Tablets

ACTIVE COMPARATOR

Drug: Clopidogrel Tablets

Interventions

Vicagrel Capsules DRUG

Vicagrel Capsules qd per period, for two periods

Vicagrel Capsules

Clopidogrel Tablets DRUG

Clopidogrel Tablets qd per period, for two periods

Clopidogrel Tablets

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 90 days after the last dose of study drug；
• Male and female subjects between the ages of 18 and 65 years, inclusive;
• At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 18-28 kg/m2, inclusive;
• With normal or clinically insignificant abnormal results of physical examination and vital signs test;

You may not qualify if:

• More than 5 cigarettes per day on average within 3 months before the study;
• History of sensitivity to drugs similar to the study drug or have high sensitivity to clopidogrel, allergic constitution (e.g. allergy to various drugs and foods);
• History of drug abuse, drug use, alcohol abuse (14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines);
• Donation or loss of a significant volume of blood (\> 450 mL) within 56 days prior to screening;
• Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
• 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;
• Intake of any drug which Have taken strong inhibitors and/or inducers of liver metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5) within 28 days before the first medication, and strong inhibitors of liver metabolic enzymes such as: ciprofloxacin, clopidogrel, Itraconazole, ketoconazole, ritonavir, troleandomycin, etc., strong inducers of liver metabolism enzymes such as: rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc.(For details see Appendix 6);
• Recent major changes in diet or exercise habits;
• Subjects who have taken other investigational drugs within 3 months prior to taking the investigational drug, or who have participated in clinical trials of other drugs and received the investigational drug within 3 months prior to taking the investigational drug;
• History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
• Suffering from any diseases that may increase the risk of bleeding, such as hemorrhoids, acute gastritis, stomach and duodenal ulcers, Thrombocytopenic Purpura and hemophilia, etc;
• Family history of coagulation or bleeding disorders (e.g., hemophilia)/symptoms (e.g., vomiting blood, black stools, severe or recurrent nosebleeds, coughing up blood, significant hematuria, or intracranial hemorrhage) or suspected vascular malformations, such as aneurysms or early onset strokes, in the individual or in their immediate family;
• A clinically significant 12-lead ECG abnormality;
• Positive test results of blood pregnancy or subject is lactating for female subjects;
• Any clinically significant abnormalities/findings in laboratory tests, or any clinically significant disease including but not limited to gastrointestinal, renal, hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases;

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xiaojiao Li

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: August 5, 2025
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-07

Locations

CN (1)