Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.

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

Inclusion criteria

• Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
• Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2

• BMI = Weight(kg)/ Height(m)2
• Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
• Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.

Exclusion criteria

• History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse

• Thiazolidinedione
• DPP-4 inhibitor
• Metformin
• Any clinically significant chronic medical illness.
• Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Individuals with one of the following laboratory test results in screening

• AST, ALT > UNL (upper normal limit) x 3
• fasting glucose < 70 mg/dL or > 125 mg/dL
• Creatinine clearance ≤ 80 mL/min
• In ECG result, QTc > 450 msec
• hCG(+) (only women)
• Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
• Use of any prescription drugs within 14 days prior to study drug administration.
• Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
• History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
• Individuals who cannot eat standard meal provided from clinical trial center.
• Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
• Individuals who had received a blood transfusion within 30 days prior to study drug administration.
• Exposure to any investigational drug within 6 months prior to the first IP administration.
• Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
• Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
• Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stopping drink.
• Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
• Pregnant or women who may be pregnant
• Subjects having been deemed inappropriate for the trial as determined by the investigator.