A Phase 1, Open-label, Randomized, Multiple-dose, Crossover Pharmacokinetic/Pharmacodynamic Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Phenotypes

Jiangsu vcare pharmaceutical technology co., LTD3 个研究点分布在 2 个国家目标入组 128 人开始时间: 2021年12月9日最近更新: 2023年11月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Jiangsu vcare pharmaceutical technology co., LTD
入组人数: 128
试验地点: 3
主要终点: maximum plasma concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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 (see Appendix 5 for details);
•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 18-32 kg/m2, inclusive;
•With normal or clinically insignificant abnormal results of physical examination and vital signs test;
•Subjects will be assigned into the group according to the CYP2C19 genotype: the first group of ultra-rapid metabolizers (CYP2C19*17/*17); the second group of rapid metabolizers (CYP2C19*1/*17); the third group of normal metabolizers (CYP2C19*1/*1); the fourth group of intermediate metabolizers (CYP2C19*1/*2, *1/*3, *2/*17, *3/*17); and the fifth group of poor metabolizers (CYP2C19*2/*2, *2/*3, *3/*3).。

排除标准

•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;
•Use of an investigational drug or product, or participation in a drug research study within 30 days (or 5 half-lives) prior to receiving study 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;
•Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody or syphilis antibody;
•Acute illness or concomitant medication from screening to the first dosing of study medication;
•Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 48 h prior to receiving the first dosing of study medication;
•Consumption of any product containing alcohol within 24 h prior to receiving the first dosing of study medication, or positive results from a screen for alcohol;
•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;
•Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study (For ultra-rapid metabolizers and rapid metabolizers, investigators may consider at their discretion).