Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

Study Overview
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Brief Summary
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This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.

Detailed Description
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Evaluation Criteria: Primary outcome Pharmacodynamic assessments using P2Y12 assay Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F of Clopidogrel Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Clopidogrel 75mg
* Drug: Tegoprazan 50 mg
* Drug: RAPA113


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males 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 ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2 at the time of screening Helicobacter pylori negative Voluntarily decided to participate in the study and provided written informed consent before any screening procedure Exclusion Criteria: Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.) P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results : Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range Blood total bilirubin levels greater than 1.5x of the upper limit of normal range Hemoglobin levels less than 12.0 g/dL eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) < 60 mL/min/1.73 m2 : eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x [serum creatinine (mg/dL)]-1.154 x [age]-0.203 positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test) Systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 50 mmHg or > 100 mmHg, or pulse rate < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel 75 mg<br>Oral administration of clopidogrel 75 mg tablet once daily for 7 days | Drug: Clopidogrel 75mg<br>* Clopidogrel 75 mg tablet<br>* Other names: Plavix;|
| Experimental: Clopidogrel 75 mg + Tegoprazan 50 mg<br>Oral administration of clopidogrel 75 mg tablet and Tegoprazan 50mg tablet once daily for 7 days | Drug: Clopidogrel 75mg<br>* Clopidogrel 75 mg tablet<br>* Other names: Plavix;Drug: Tegoprazan 50 mg<br>* Tegoprazan 50 mg tablet<br>* Other names: K-CAB;|
| Experimental: Clopidogrel 75 mg + RAPA113<br>Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days | Drug: Clopidogrel 75mg<br>* Clopidogrel 75 mg tablet<br>* Other names: Plavix;Drug: RAPA113<br>* RAPA113 tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in P2Y12 Reaction Unit (PRU) from baseline | Pharmacodynamics blood sampling to measure PRU using VerifyNow® system | Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period |