Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

Launched by HK INNO.N CORPORATION · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how two medications, tegoprazan and esomeprazole, affect the way clopidogrel works in healthy adults. Clopidogrel is a medication that helps prevent blood clots, and the researchers want to see if taking it with either tegoprazan or esomeprazole changes its effectiveness. The trial is currently not recruiting participants but aims to include healthy adults aged between 19 and 50 years, who weigh between 55 kg and 90 kg and have a body mass index (BMI) within a specific range. Participants must also not have any significant health issues, particularly related to the liver, kidneys, or gastrointestinal system.

If you qualify and choose to participate, you will undergo a series of screenings to ensure your health and safety before starting the trial. During the study, you may receive either of the two medications along with clopidogrel, and researchers will closely monitor how your body responds to this combination. It's important to know that the trial has strict eligibility criteria to protect your health, and the study team will provide detailed information and support throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adults aged ≥ 19 years and ≤ 50 years on the date of the written informed consent
• • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
• • Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
• • Negative for serum Helicobacter pylori antibodies
• • Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
• Exclusion Criteria:
• • Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
• • Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
• • Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• • Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• • Blood total bilirubin, AST (GOT), and ALT (GPT) \> 1.5 x upper limit of normal range at the screening test
• • Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at the screening test
• • Systolic blood pressure is \< 90 mmHg or \> 139 mmHg, diastolic blood pressure \< 50 mmHg or \> 89 mmHg, or pulse rate is \< 45 beats/minute or \> 100 beats/minute when vital signs are measured in sitting position after resting for at least 3 minutes at the screening test
• • Showing the following findings on ECG at the screening test: QTc \> 450 msec, PR interval \> 210 msec, QRS interval \> 120 msec, Other clinically significant findings
• • P2Y12 Reaction Unit (PRU) outside the upper/lower limit of normal range by 10% as a result of P2Y12 assay at the screening test
• • History of drug abuse or positive urine screening for drug abuse
• • Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons