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

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

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