A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(6)

Prior treatment

• 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 and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
• Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
• Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
  • Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1glass: Soju 50mL, Wine 30mL, or beer 250mL)
  • Smoking: 20 cigarettes/day

Other illness

• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to Sunset yellow FCF.

Lab values

• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

Other

• Those who are deemed insufficient to participate in this clinical trial by investigators.
• Woman who are pregnant or breastfeeding.

• Healthy adult volunteers aged ≥ 19 years.
• Body weight ≥55kg 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 ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.