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
Yes for 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 exclusion criteria 1
No for 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 exclusion criteria 1
Not sure for 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 exclusion criteria 1
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
Yes for 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 exclusion criteria 2
No for 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 exclusion criteria 2
Not sure for 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 exclusion criteria 2
Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc
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
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
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
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
Those who continue to smoke (>10 cigarettes/day), or who are unable stop smoking during hospitalization within the clinical study period
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
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
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.)
Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation
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
Pregnant women, potentially pregnant women, or breast-feeding women
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
Those who are unwilling or unable to comply with the dietary and lifestyle guidelines
required for the clinical study
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.)