A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult Subjects

Jiangsu vcare pharmaceutical technology co., LTD1 site in 1 country24 target enrollmentAugust 24, 2021

ConditionsAcute Coronary Syndrome

Interventionsvicagrel

Drugsvicagrel

Overview

Phase: Phase 1
Intervention: vicagrel
Conditions: Acute Coronary Syndrome
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Enrollment: 24
Locations: 1
Primary Endpoint: AUC
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects.

Registry

clinicaltrials.gov

Start Date

August 24, 2021

End Date

October 20, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary signing of informed consent before the trial, and full understanding of the experimental content, process and possible ARs;
•Able to complete the study according to the protocol;
•Subjects (and their partners) are willing to take effective contraceptive measures from screening to 6 month after the last dose of the IMPs. See Appendix 5 for specific contraceptive measures;
•Male and female subjects aged 18 to 45 years (inclusive);
•Male weight ≥50 kg, female weight ≥ 45 kg. Body mass index (BMI) = body weight (kg) / height2 (m2). BMI ranging from 18 to 28 kg/m2 (including critical values);
•Physical examination and vital signs are normal or abnormal without clinical significance.

Exclusion Criteria

•More than 5 cigarettes per day on average 3 months before the trial;
•Allergic constitution (allergic to multiple drugs and foods), or known to be possibly allergic to drugs of the same class of the IMP or highly sensitive to clopidogrel;
•History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or use of hard drug within the past five years;
•Blood donation or massive blood loss (\>450 mL) within 3 months before screening;
•Presence of dysphagia or history of any gastrointestinal and hepatic, renal disease (whether cured or not) or history of surgery that affects absorption or excretion of the IMP within 6 months prior to screening;
•With any disease that increases the risk of bleeding, such as acute gastritis, stomach and duodenal ulcers, or history of abnormal bleeding (e.g. bleeding time prolonged after tooth extraction);
•The subject or his or her immediate family member has a family history of coagulation or haemorrhagic disorders (such as haemophilia)/symptoms (such as hematemesis, melena, severe or recurrent epistaxis, coughing blood (hemoptysis), obvious hematuria or intracranial hemorrhage), or suspected vascular malformation, such as aneurysm or early-onset stroke;
•Took potent inhibitors and/or inducers of CYP enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5) within 28 days prior to the first dose. Potent inhibitors of CYP enzymes include ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc.. Potent inducers of CYP enzymes include rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc.. See Appendix 6 for details;
•Took any prescription, non-prescription, any vitamin or herbal drugs within 14 days before the first dose;
•Had foods that affect CYP3A4 metabolism within 2 weeks prior to the first dose, such as grapefruit or grapefruit-containing beverages, or had intense physical exercise (e.g. strength training, aerobic training, and playing football) within 7 days prior to the first dose, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;