A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001844
- Lead Sponsor
- Chong Kun Dang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 26
1.Healthy man older than 19 years at the time of screening.
2.BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
3.Subject without congenital or chronic diseases and no psychotic symptoms or findings from
the medical examination.
4.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 Electrocardiogram test.
5.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.
6.Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
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. alanine transferase or Aspartate transaminase > 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast of Lobeglitazone ;Cmax of Lobeglitazone ;AUClast of Metformin;Cmax of Metformin
- Secondary Outcome Measures
Name Time Method Tmax of metformin;AUCinf of Lobeglitazone;Tmax of Lobeglitazone; t1/2 of Lobeglitazone;CL/F of Lobeglitazone;Vd/F of Lobeglitazone;AUCinf of metformin; t1/2 of metformin;CL/F of metformin;Vd/F of metformin