| 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 30.0 kg/m2
3. Those who have been determined to be eligible as subjects through physical
examinations and interviews 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. Those who have been determined to be eligible as subjects as a result of clinical
laboratory tests and electrocardiography performed according to this protocol (if the
results are within the reference values of Inha University Hospital or if the
investigator determines that the clinical laboratory test and electrocardiography
results are not clinically significant even if they are out of range)
5. Those who 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 associated with the cardiovascular
system, respiratory system, liver, kidney, nervous system, endocrine system,
blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a
history thereof.
2. Those who have hypersensitivity reactions to drugs containing fimasartan, amlodipine,
ezetimibe, atorvastatin, or same-class ingredients, yellow no. 5 (sunset yellow FCF),
dihydropyridine derivatives, or to other drugs (aspirin, antibiotics, etc.), or a
history of clinically significant hypersensitivity reactions thereto.
3. Those who have a hereditary disorder including galactose intolerance, Lapp lactase
deficiency, glucose-galactose malabsorption, etc.
4. Those who have a history of gastrointestinal diseases (e.g., Crohn's disease,
ulcerative disease, etc.) or gastrointestinal surgery (however, simple appendectomy or
hernia repair are excluded) that may affect the absorption of drugs
5. Those who have clinically significant hypotension (systolic blood pressure = 90 mmHg)
or hypertension (systolic blood pressure = 150 mmHg or diastolic blood pressure = 95
mmHg) at screening
6. Those who show 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
- CK > 2 times the upper limit of the normal range
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
7. Those who continue to drink alcohol (>21 units/week; 1 unit = 10 g = 12.5 mL of pure
alcohol), or who are unable to abstain from drinking during the clinical study period
8. Those who continue to smoke (>10 cigarettes/day), or who are unable stop smoking
during hospitalization within the clinical study period
9. Those who have participated in another clinical study 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
10. Those who have donated whole blood within 60 days prior to the first day of
administration or donated blood components within 30 days prior to the first day of
administration or who have received a blood transfusion within 30 days
11. 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
study.)
12. Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as
barbiturates, within 30 days prior to the study initiation
13. 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
14. Pregnant women, potentially pregnant women, or breast-feeding women
15. Those who do not agree to rule out the possibility of their and their spouses' or
sexual partners' pregnancy by using 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 study
- Medically acceptable methods of contraception: Combined use of intrauterine
device, vasectomy, tubal ligation, and barrier methods (male condom, female
condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more
barrier methods if spermicide is used
16. Those who are unwilling or unable to comply with the dietary and lifestyle guidelines
required for the clinical study
17. 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 study due to other reasons (e.g., non-compliance with
instructions, uncooperative attitude, etc.)
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