Healthy
Conditions
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, Vd,ss/F, and PTF of clopidogrel * Safety assessments with adverse event monitoring including subjective/ objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Interventions
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in P2Y12 Reaction Unit (PRU) from baseline | Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period | Pharmacodynamic blood sampling to measure PRU using VerifyNow® system |
Countries
South Korea
Contacts
Primary ContactEun Ji Kim
Backup ContactHee Hyun Kim
Outcome results
None listed