A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers

To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.

Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glicophage XR Tab. 1000mg 1T Treatment B(Test Drug): CKD-395 0.5/1000mg Tab. 1T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.

Inclusion criteria

• Healthy man older than 19 years at the time of screening.
• BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
• Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
• Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
• Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
• Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

Exclusion criteria

• Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
• Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
• Subjects who show AST or AST > 2 times upper limit of normal range.
• Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
• Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
• Subjects who show Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg at screening.
• Subjects who have history of alcohol or drug abuse, within 1 year
• Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
• Smoker ( ≥ 20cigarettes/day)
• Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
• Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
• Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
• Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
• Patients with severe heart failure or congestive heart failure of needing drug therapy
• Patients with liver disease
• Patients with severe renal disease
• Patients with diabetes mellitus with ketoacidosis, diabetes coma and prior
• Patients before or after surgery, with severe infections, severe trauma
• Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with renal disease or renal failure caused by cardiovascular collapse, acute myocardial infarction, sepsis (Serum creatinine ≥ 1.5mg/dL or abnormal creatinie clearance)
• Patients who had a test to injecting radioactive iodine in vein
• Patients with severe infections or severe traumatic whole body injuries
• Patients with undernourishment condition or starvation state or hyposthenia or hypopituitarism, or hypoadrenalism
• Patients with respiratory failure, or stomach disease
• Subjects who is not able to intake high fat meals
• Subjects who is not able to comply with guidelines described in the protocol.
• Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.