A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers
A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers
This study is a randomized, open-label, single dose, 2-way crossover study to compare the
 pharmacokinetic characteristics of CKD-395 0.25/500 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 + Glucophage XR Tab. 500mg 2T Treatment
 B(Test Drug): CKD-395 0.25/750mg Tab. 2T

 Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are
 assessed.
Inclusion Criteria:

 1. A healthy male whose age is over 19 years old when visiting for initial screening test

 2. Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg

 -  Body mass index (BMI) = weight (kg) / height (m)^2

 3. A male with no congenital or chronic disease in three years, no history of symptoms in
 internal treatment, or no knowledge in the area

 4. Due to the special characteristics of drugs, the participators must be qualified to do
 the clinical screening after examined through hematology test and blood chemistry
 analysis, urinary test, the electrocardiogram (ECG), and etc.

 5. The participants must be volunteered and sign in an informed consent document proven
 by Chonbuk National University IRB before joining a study to show that he was given
 informed the purpose of tests and the special characteristics of drugs.

 6. The participants must have an ability and willingness to participate throughout the
 entire trials

 Exclusion Criteria:

 1. A person who had a history or symptoms of clinically aware of blood, kidney, internal
 secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous,
 or allergic (except subclinical seasonal allergies that is not treated at injection)
 disease.

 2. Who had a history of gastrointestinal related disease which can be affected the drug
 absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's
 disease) or surgeries (except a simple appendectomy or herniotomy)

 3. Who had following results after examination

 a. ALT or AST > twice higher than normal value

 4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup
 of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%)
 (125 mL) = 12 g)

 5. Who participated other clinical test or took testing bioequivalence drugs in 3 months
 before the first clinical drug trial

 6. Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic
 pressure)

 7. Who had a medical history of alcohol and drug abuses.

 8. Who had taken a drug that has a control of metabolic rate (activation or inhibition)
 in 30 days before the first taking of clinical testing drug

 9. Who smokes more than 20 cigarettes per day

 10. Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very
 first clinical testing drug

 11. Who participated in whole blood donation in 2 months before the first taking of
 clinical testing drugs or platelet donations in 1 month before the first taking to
 clinical testing drugs.

 12. Who has a potent to increase a danger by participating in the clinical trials or who
 can interrupt interpreting test results by having serious or chronic medical and
 mental status or having issues in results of the screening examination.

 13. Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or
 drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain
 the ingredients of Metformin or biguanidine drugs

 14. Who has a serious heart failure or a congestive heart failure that must be
 drug-treated

 15. A patient with hepatopathy

 16. A patient with severe nephropathy

 17. Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history
 of acute metabolic acidosis or ketoacidosis

 18. A patient with serious infectious disease or severe injuries before and after a
 surgery

 19. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose
 malabsorption or genetic disorders

 20. A patient who has kidney disease or renal insufficient that are caused by
 cardiovascular collapse (shock) and acute myocardial infarction (a male with higher
 serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min)

 21. A patient who is being tested to inject radiological iodine contrast agent into blood
 vessels (ex: intravenous urography, intravenous cholangiography, angiography, using
 contrast medium computer tomography, etc.)

 22. Who has severe systematic infection or severe trauma

 23. Who has nutritional status, starvation, debilitating condition, pituitary dysfunction,
 or adrenal insufficiency patients

 24. Who has respiratory dysfunction, gastrointestinal disease

 25. Who is unable to take high fat foods

 26. Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from
 the first dosing of clinical testing drug to collect pharmacokinetic blood samples

 27. Test subjects who is not willing or unable to comply with guidelines described in this
 protocol

 28. A person who is not determined unsuitable to participate in this test by the
 researchers