| Eligibility |
Inclusion Criteria:
- healthy adult volunteers aged 19 and above.
- For males, a weight of 50.0 kg or more, and for females, a weight of 45.0 kg or more,
with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2.
BMI(kg/m2)=Weight(kg)/height(m)2
- No congenital or chronic diseases requiring treatment, and no pathological symptoms or
findings based on internal medicine examination.
- Those who were determined to be suitable subjects for clinical trials as a result of
tests such as clinical laboratory tests, vital signs, physical examination (physical
examination), and 12-lead electrocardiogram
- Negative for H. pylori antibodies
- After receiving detailed explanations about the clinical trial and fully
understanding, participants voluntarily decide to participate and provide written
consent to adhere to the subject compliance requirements throughout the trial period.
Exclusion Criteria:
- Current or past medical history of clinically significant conditions involving the
liver, kidneys, nervous system, mental health, respiratory system, endocrine system,
blood disorders, tumors, genitourinary system, cardiovascular system, digestive
system, musculoskeletal system, etc., and in addition:
- currently receiving antiretroviral drugs (rilpivirine, atazanavir, nelfinavir)
- liver disorders
- kidney disorders
- History of gastrointestinal conditions (Crohn's disease, ulcers, acute or chronic
pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia
repair) that may affect the absorption of the investigational drug.
- Pregnant (positive Urine-HCG) or lactating for female participants
- Have a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or
clinically significant hypersensitivity reactions to drugs, excipients, or other
substances, including medications containing the active ingredients of the
investigational drug, additives, and other drugs (such as aspirin, penicillin
antibiotics, macrolide antibiotics).
- Have clinically significant findings on the 12-lead electrocardiogram during
screening, including:
- QTc interval > 450 ms for males or > 470 ms for females.
- PR interval > 200 ms.
- QRS duration > 120 ms.
- Showing the following results in clinical trial laboratory tests during screening:
- liver function assessment: AST, ALT, ALP, ?-GTP, and total bilirubin exceeding
twice the upper limit of the normal range.
- Blood creatinine levels outside the reference range or calculated estimated
glomerular filtration rate (eGFR) using the CKD-EPI formula less than 60
mL/min/1.73m2.
- History of drug abuse or individuals who have shown a positive reaction for abused
substances in a urine drug test.
- During screening, exhibit vital signs measured after at least 3 minutes of rest in a
seated position with systolic blood pressure (SBP) = 150 mmHg or = 90 mmHg, diastolic
blood pressure (DBP) = 100 mmHg or = 60 mmHg, or a heart rate (HR) = 40 bpm or = 100
bpm.
- Have an abnormal diet that could affect the absorption, distribution, metabolism, or
excretion of the investigational drug, or individuals who consume foods that could
impact drug metabolism.
- Administered any prescription medications or herbal products that could influence the
characteristics of the investigational drug within 2 weeks before the first dose or
any OTC drugs or vitamin supplements within 10 days before the first dose. (If there
is no effect on the pharmacokinetic properties of this investigational drug, the
investigator may participate in the clinical trial at the discretion of the
investigator.)
- Administer drugs that induce or inhibit drug-metabolizing enzymes, such as
barbiturates, within 1 month before the first administration date.
- Participated in other clinical trials within 6 months prior to the first
administration date (The endpoint for determining the end of participation in another
clinical trial is considered one day after the last administration in that trial.)
- Those who have consistently consumed alcohol in excess of 21 units/week (1 unit = 10 g
= 12.5 mL of pure alcohol) within 6 months prior to the first administration date or
who are unable to abstain from alcohol from the time of written consent to the time of
PSV.
- Smokers who smoke more than 10 cigarettes on average per day within 3 months before
the first administration date and those who are unable to quit smoking from 24 hours
before each administration until the time of the last blood collection
- Consumed food containing grapefruit or cannot refrain from eating it from 48 hours
before the first administration until the time of PSV
- Those who consumed caffeine-containing foods (coffee, green tea, black tea, carbonated
drinks, coffee milk, tonic drinks, etc.) during the period from 24 hours before
administration to the time of the last blood collection, or who cannot refrain from
consuming them.
- Those who engaged in vigorous exercise exceeding the level of daily life during the
period from 48 hours before the first administration to the time of PSV, or who cannot
refrain from vigorous exercise
- From the time of the subject's written consent until 2 weeks after the last
administration of the investigational drug, even if the person, spouse, or partner is
planning to become pregnant or is not planning to become pregnant, a recognized method
of contraception (e.g., administration of contraceptives, implantation or intrauterine
device, sterilization procedure (vasectomy), not using surgical resection, tubal
ligation, etc.) or blocking methods (combined use of spermicides, condoms,
contraceptive diaphragms, vaginal sponges, or cervical caps)
- Judged by the investigator to be unsuitable for participation in clinical trials due
to reasons other than the above selection/exclusion criteria
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