| Eligibility |
Inclusion Criteria:
1. Healthy adult, age = 19 years at the time of screening
2. Body weight = 50.0 kg, with body mass index (BMI) = 18.0 kg/m2 and = 30.0 kg/m2 at the
time of screening
3. A subject with no congenital, treatment-requiring chronic diseases, pathologic
symptoms, or findings on internal medicine examination.
4. A subject determined to be suitable for the study as a result of clinical laboratory
tests, vital signs, medical examination (physical examination), 12-lead
electrocardiogram, and other tests set according to the characteristics of the
investigational drug.
5. A subject voluntarily decided to participate and agreed in writing to comply with the
subject compliance for the duration of the clinical trial.
Exclusion Criteria:
1. A subject with a current clinically significant liver, kidney, nervous, psychiatric,
respiratory, endocrine, hematologic, tumor, genitourinary, cardiovascular, digestive,
musculoskeletal, etc. diseases or history
1. Kidney disorders
2. Liver disorders
3. Those with bleeding disorders (peptic ulcer, intracranial hemorrhage, hemophilia,
digestive tract bleeding, urinary tract bleeding, hemorrhage, vitreous
hemorrhage, etc.)
2. For women, pregnant women (Urine-HCG positive) or nursing mothers
3. A subject hypersensitivity or history of clinically significant hypersensitivity to
clopidogrel, tegoprazan, or any component of the investigational drug, aspirin, or
benzimidazole
4. A subject with a genetic condition such as galactose intolerance, Lapp lactase
deficiency, or glucose-galactose malabsorption
5. A subject with a history of gastrointestinal disease (Crohn's disease, ulcers, acute
or chronic pancreatitis, etc.) or gastrointestinal surgery (but not simple
appendectomy or hernia surgery) that may affect the absorption of the investigational
drug.
6. A subject with clinically significant findings on 12-lead electrocardiogram at
screening, including the following findings
1. QTc > 450 ms in men and QTc > 470 ms in women
2. PR interval > 200 ms
3. QRS duration > 120 ms
7. A subject with the following findings in clinical laboratory tests at the time of
screening
1. AST, ALT, ALP, ?-GT, and Bilirubin total > 2 times the upper limit of normal
range in clinical laboratory tests for liver function evaluation
2. Creatinine level in the blood exceeds the reference range or eGFR calculated by
the CKD-EPI formula less than 60 mL/min/1.73 m2
3. CPK > 2.5 times the upper limit of the normal range in clinical laboratory tests
8. A subject with a history of drug abuse or positive urine drug screen for drugs of
abuse
9. A subject with systolic blood pressure = 150 mm Hg or = 90 mm Hg or diastolic blood
pressure = 100 mm Hg or = 60 mm Hg and pulse = 40 bpm or = 100 bpm, which was measured
in the sitting position after at least 3 minutes of rest, at the time of screening
10. A subject administered drugs that induce or inhibit drug-metabolizing enzymes, such as
barbiturates, within 1 month before the first dose.
11. A subject with an unusual diet that may affect the absorption, distribution,
metabolism, and excretion of the investigational drug or consume foods that may affect
drug metabolism
12. A subject who received any specialty or herbal medications that may affect the
properties of the investigational product, including cyclosporine, CYP2C19 inhibitors,
atazanavir, nelfinavir, or rilpivirine-containing preparations within 2 weeks before
the first dose, or any over-the-counter (OTC) or vitamin preparations within 10 days
(however, if the medication does not affect the pharmacokinetic properties of the
investigational product, the subject may participate in the study at the discretion of
the investigator).
13. A subject who participated in and received treatment in another clinical trial within
6 months before the first dose (however, the termination criteria for participation in
another clinical trial shall be the day following the last dose.)
14. A subject who donated whole blood within 2 months before the first dose, or component
blood within 1 month, or received a blood transfusion within 1 month, or needed to
must donate blood from written informed consent to the time of PSV.
15. A subject with consistent alcohol consumption (> 21 units/week, 1 unit=10 g=12.5 mL of
pure alcohol) within 6 months before the first dose or unavailable to stop alcohol
consumption from written informed consent to the time of PSV
16. A subject who smokes with an average daily cigarette consumption greater than 10
cigarettes within 3 months before the first dose and who is unable to quit smoking
from 24 hours before the first dose at each time point until the time of the last
blood draw.
17. A subject with consumption of or inability to abstain from grapefruit
(grapefruit)-containing foods from 48 hours before the first dose until the time of
PSV
18. A subject with consumption of or inability to abstain from caffeine-containing foods
(coffee, green tea, black tea, carbonated beverages, coffee milk, tonic drinks, etc.
19. A subject who engaged in vigorous exercise that exceeds the level of their daily
routine from 48 hours before the first dose to the time of PSV, or unavailable to
abstain from vigorous exercise.
20. A subject or his/her spouse or partner who is planning to become pregnant from written
informed consent until 2 weeks after the last dose of investigational product, or is
not using a reliable method of contraception (e.g., contraceptive administration and
implantation or intrauterine device, sterilization (vasectomy, tubal ligation, etc.),
barrier method (combination of spermicide with condoms, contraceptive vaginal septum,
vaginal sponge, or neck cap)).
21. A subject unsuitable for participation in the study by the investigator for any reason
other than the above inclusion/exclusion criteria
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