Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects

To healthy 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D745, D759 / Test drug: CKD-371

Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Inclusion criteria

• Healthy adults volunteers aged between 19 and 45 years old at the time of screening
• Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
• 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 with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
• Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
• Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
• Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
• Those with clinically significant active chronic disease
• Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
• A person who has had one or more of the following results in screening tests including re-examination

• AST, ALT > UNL (upper normal limit) x 2.5
• Fasting glucose < 70 mg/dL
• Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) * (Wt in kg) / (72 * Cr))
• QTc > 470 msec as a result of ECG
• Urine-hCG test is positive(if it is limited to female subjects)
• Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
• Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
• Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose
• Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected
• Those who cannot eat the standard meal provided by the institution
• Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days
• Those who received a blood transfusion within 30 days prior to the first dose
• Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug
• Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product
• Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization
• Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization
• Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization
• Pregnant or childbearing potential and lactating women
• Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product
• Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude