| Eligibility |
Inclusion Criteria:
1. Healthy male volunteers, aged = 19 years old at the time of screening
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5 kg/m2
3. Those who do not have congenital or chronic diseases and have no pathological symptoms
or findings as a result of medical examination
4. Clinical laboratory tests (hematology tests, blood chemistry tests, urinalysis,
serological tests, etc.) conducted by the principal investigator(or the investigator
who has been delegated) according to the characteristics of the drug and screening
tests such as vital signs and electrocardiogram tests Result Those who are judged to
be suitable as test subjects
5. Before participating in the trial, the purpose and contents of the trial were fully
explained, and the participants agreed to participate in this study voluntarily who
signed
6. After the first administration of the clinical trial drug, for up to 14 days after the
last administration of the investigational drug, you, your spouse, or your partner
must agree to maintain the use of an appropriate medically acceptable method of
contraception* except for hormonal contraceptives and not donate sperm or eggs ruler
7. Those who have the ability and willingness to participate during the entire
examination period
Exclusion Criteria:
1. A history of clinically significant blood, renal, endocrine, respiratory,
gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune
disease (except for simple dental history of calculus, impacted teeth, wisdom teeth,
etc.) or evidence one who has 1-1. Patients with hypersensitivity or a history of
hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine
derivatives, thiazide diuretics, or sulfonamide drugs 1-2. Pregnant (2nd and 3rd
trimester) or women who may be pregnant 1-3. Lactating women 1-4. Patients with
biliary atresia 1-5. Patient with Severely liver dysfunction 1-6. Patient with
Severely aortic valvular stenosis 1-7. Shock patient 1-8. Patients with genetic
problems such as intolerance to this drug's additives 1-9. Patients with diabetes or
moderate to severe renal impairment (glomerular filtration rate <60mL/min/1.73m2) who
used aliskiren-containing agents in combination 1-10. Patients with anuria 1-11.
Patients with severe renal failure (creatinine clearance <30 mL/min) 1-12. Patients
with refractory hypokalemia 1-13. Patients with hyponatremia and hypercalcemia 1-14.
Patients with symptomatic hyperuricemia (history of gout or urolithiasis) 1-15.
Untreated Addison's syndrome patients 1-16. Patients receiving lithium therapy 1-17.
Patients taking terfenadine or astemizole
2. Those with a history of gastrointestinal diseases (esophageal diseases such as
achalasia or esophageal stricture, Crohn's disease) or surgery(except simple
appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug
absorption ruler
3. A person who shows the following values as a result of conducting a clinical
laboratory test
- ALT or AST > 2 times the upper limit of the normal range
4. Smokers who smoked more than 20 cigarettes a day within 6 months of screening
5. Those who have taken other clinical investigational drugs or bioequivalence
investigational drugs within 6 months before the first administration of the clinical
investigational drug
6. Those who meet the following as a result of measuring vital signs at screening
- Those who have a systolic blood pressure of less than 90 mmHg or more than 140
mmHg or a diastolic blood pressure of less than 60 mmHg or more than 90 mmHg in
the sitting position
- Severe bradycardia (less than 50 beats/min)
7. Those with a history of regular alcohol intake within 1 month of screening
- More than 14 drinks/Week for women
- More than 21 drinks/Week for men
8. A person who has taken a drug known to significantly induce or inhibit drug
metabolizing enzymes within 30 days before the first administration of the clinical
trial drug
9. Those who have taken prescription or non-prescription drugs within 10days prior to the
first administration of clinical trial drugs
10. Those who have donated whole blood within 2 months before the first administration of
the clinical trial drug, donated component blood within 1 month, received blood
transfusion within 1 month, or have plans for the trial during the clinical trial
period
11. Those who are judged by the principal investigator (or the person in charge of the
test who has been delegated) for reasons other than the above selection/exclusion
criteria and are judged unsuitable for participation in this study
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