| Eligibility |
Inclusion Criteria:
1. Healthy adult volunteers aged = 19 years
2. Weight =50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30
kg/m2
3. Those who meet the blood pressure criteria during screening tests:
- Systolic Blood Pressure: 90 to 139 mmHg
- Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal
symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory(hematology, blood
chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the
cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
1. Those who received investigational products or participated in bioequivalence tests
within 6 months before the first administration of clinical trial drugs.
2. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as
barbiturates, within 1 month before the first dosing date, or who have used drugs that
may interfere with this study within 10 days before the first dosing day (However,
clinical investigational drugs) Participation is possible in consideration of
pharmacokinetic and pharmacodynamic characteristics such as interaction with
concomitant drugs and half-life of concomitant drugs)
3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or
received blood transfusion within a 4 weeks.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and
hernia surgery.
5. Those who exceed an alcohol and cigarette consumption than below criteria
• Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL,
or beer 250mL)
• Heavy Smoking: 20 cigarettes/day
6. Patients with the following diseases
- Patients with hypersensitivity to the main constituents or components of the
investigational drug
- Severe hepatic impairment, biliary atresia or cholestasis
- Patients with hereditary angioedema or with a history of angioedema in the
treatment of ACE inhibitors or angiotensin II receptor antagonists
- Diabetes mellitus
- Patients with moderate to severe renal impairment [glomerular filtration rate
(eGFR) <60 mL / min / 1.73m^2]
- Renal vascular hypertension patients
- Patients with active liver disease, including unexplained persistent serum
transaminase elevations or elevated serum transaminase elevations greater than
three times the normal upper limit
- Patients with myopathy or have a history of family or genetic history of myopathy
- Hypothyroidism
- If you have a history of muscle toxicity for other HMG-CoA converting enzymes or
fibrate class drugs
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency
or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by
investigators.
9. Woman who are pregnant or breastfeeding.
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