PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.

Inclusion Criteria:Healthy adults aged ≥ 19 years to < 55 years at the time of screeningThose with body weight ≥ 45 kg (but ≥ 60 kg for cohort 1 and cohort 2) and body mass index (BMI) in the range of 19.0 kg/m2 to 27.0 kg/m2 at the time of screening☞ BMI = weight (kg) / height (m)2Those who have neither congenital/chronic disease (within recent 3 years) nor pathological symptoms/findings as a result of medical examinationThose determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicinesThose who are fully informed of study purpose, procedures, etc., voluntarily decide to participate in this study, and sign an informed consent form (ICF) approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital, prior to participation in the studyThose with a capability/willingness to participate throughout the studyExclusion Criteria:Medical history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal (peptic ulcer, etc.), urinary, cardiovascular, hepatic, psychiatric, neurological or immune disease (but except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth) or evidence thereofPrevious history of gastrointestinal disease (except for esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (not including simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorptionFollowing findings of clinical laboratory tests:☞ ALT or AST value > twice the upper limit of normal (ULN)History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)Administration of another investigational product within 6 months prior to the first dose of the investigational productHistory of serious alcohol or drug misuse and abuse within 1 year prior to screeningAdministration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational productHistory of smoked cigarettes ≥ 20 cigarettes/day within 6 months prior to screeningAdministration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational productWhole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational productThose who may be put at an increased risk due to the adminisration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study resultsPatients with hypersensitivity to tegoprazan, edoxaban, apixaban, rivaroxaban, etc. (e.g., asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reactions, etc.)Patients with a clinically significant bleedingPatients with hemostatic disorder and hepatic disease related to a clinically significant risk of bleedingSevere hepatic impairmentRenal impairment (eGFR <60 ml/min/1.73m2)Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorptionPregnant/breast-feeding womenThose who cannot use medically acceptable contraceptive methods throughout the study▶ Medically acceptable contraceptive methodsUse of intrauterine device (IUD) showing a demonstrated pregnancy failure rateCombined use of barrier contraceptive method (for male or female) and spermicideUse of vasectomy, tubectomy/tubal ligation, or hysterectomyThose who are not eligible for the study in the judgment of the investigator