A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386 with co-administration of D013, D326, and D337 in healthy adult volunteers

Inclusion criteria

• Healthy adult volunteers aged ≥ 19 years
• Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
• Those who meet the blood pressure criteria during screening tests:

• Systolic Blood Pressure: 90 to 139 mmHg
• Diastolic Blood Pressure: 60 to 89 mmHg
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• 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

• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
• Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• 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)

• Smoking: 20 cigarettes/day
• 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
• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• Those who are deemed insufficient to participate in this clinical study by investigators.
• Woman who are pregnant or breastfeeding.