KCT0001783已完成未知
A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers
Chong Kun Dang0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •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 ECG 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.
排除标准
- •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
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