| Eligibility |
Inclusion Criteria:
1. Healthy adults aged 19 to 55 years at screening
2. Those who weigh at least 50 kg at the time of screening and have a calculated body
mass index (BMI) within the range of 18.0 to 29.0 kg/m2
3. Determined to be eligible as subjects through physical examination and interview
conducted in accordance with this protocol. In other words, those who have no
congenital or chronic diseases and have no abnormal symptoms or findings based on
medical examination results within the last 3 years
4. Determined to be eligible as subjects as a result of clinical laboratory tests and
electrocardiography performed according to this protocol
5. Voluntarily decide to participate in the study and provide written consent to follow
the study directions after listening to and fully understanding the detailed
explanation on this study
Exclusion Criteria:
1. Those who have clinically significant diseases or a history of the diseases associated
with the cardiovascular system, respiratory system, liver, kidney, nervous system,
endocrine system, blood/tumor, psychiatric diseases, or urinary system
2. Those who have hypersensitivity reactions or a history of clinically significant
hypersensitivity reactions to drugs containing varenicline, or drugs containing the
same class ingredients, or other drugs
3. Those with clinically significant hypotension (systolic blood pressure = 90mmHg) or
hypertension (systolic blood pressure = 150mmHg or diastolic blood pressure = 95mmHg)
at the time of screening
4. Those with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, etc.)
or gastrointestinal surgery (however, simple appendectomy or hernia repair are
excluded) that may affect the absorption of drugs
5. Any of the following results in the screening tests
- AST or ALT > 2 times the upper limit of the normal range
- Total bilirubin > 2.0 mg/dL
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
6. Those who continue to drink alcohol (>21 units/week; 1 unit = 10 g = 12.5 mL of pure
alcohol), or are unable to abstain from drinking during the clinical study period
7. Those who continue to smoke (>10 cigarettes/day) or cannot stop smoking during
hospitalization during the clinical trial period
8. Those who have participated in another clinical trial or bioequivalence test (the last
day of administration of the investigational product or bioequivalence test drug)
within 6 months prior to the first administration date
9. Those who have donated whole blood within 60 days prior to the first day of
administration or donated blood components (apheresis) within 30 days prior to the
first day of administration or who have received a blood transfusion within 30 days
10. Those who took any prescription drugs or herbal medicines within 14 days prior to the
first day of administration or any over-the-counter (OTC) drugs within 7 days prior to
the first day of administration (however, if other conditions are appropriate
according to the judgment of the investigator, they may participate in the clinical
trial.)
11. Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as
barbital, within 30 days prior to the study initiation
12. Those who have been on a diet (especially grapefruit juice or its products) that may
affect the absorption, distribution, metabolism, and excretion of the drug within 7
days prior to the first day of administration
13. Pregnant woman, potentially pregnant woman, or breast-feeding woman
14. Those who do not agree to rule out the possibility of their and their spouses' or
sexual partners' pregnancy using a medically acceptable methods of contraception*
throughout the entire period from the date of the first administration of the
investigational product to the end of the clinical trial
15. Those who are unwilling or unable to comply with the dietary and lifestyle guidelines
required for the clinical trial
16. Those who have clinically significant abnormalities in the results of other clinical
laboratory tests or who have been determined by the investigator to be ineligible to
participate in the clinical trial due to other reasons (e.g., non-compliance with
instructions, uncooperative attitude, etc.)
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