A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects

Inclusion criteria

• Healthy adult older than 19 years and less than 55 years at the time of screening
• BMI 18.5~29.9 kg/m2 and body weight more than 50kg
• Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
• Subjects who sign on an informed consent form willingly

Exclusion criteria

• Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
• Subjects who have acute disease within 28 days prior to the first administration
• Subjects who have history that may affect the ADME
• Subjects who have clinically significant chronic disease
• Women who are nursing, pregnant or positive on pregnancy test
• Subjects who have clinically significant allergic diseases
• Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Subjects who are known to be hypersensitive to the drug or its components
• Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
• Subjects with creatinine clearance <60 ml / min
• Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
• Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
• Subjects who can not eat standard meals provided by the institution.
• Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
• Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
• Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
• Subjects who participate in the other clinical trial within 90 days prior to the first administration
• Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
• Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
• Subjects who is determined unsuitable to participate in this clinical trial by the investigator