Status:
UNKNOWN
Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults
Detailed Description
Evaluation Criteria: * Primary outcome Pharmacodynamic assessments using P2Y12 assay * Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06164834
Start Date
December 5 2023
End Date
November 1 2024
Last Update
December 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea