KCT0001627已完成未知
A randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers
Chong Kun Dang0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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. 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)
- •2. Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •3. Subjects who show AST or AST > 2 times upper limit of normal range.
- •4. Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- •5. Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- •6. Subjects who show Systolic Blood Pressure > 140 mmHg or Diastolic Blood Pressure > 90 mmHg at screening.
- •7. Subjects who have history of alcohol or drug abuse, within 1 year
- •8. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •9. Smoker ( = 20cigarettes/day)
- •10. Subjects who takes Ethical The Count or Over The Count medicine within 10days before the first IP administration.
- •11. Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- •12. 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.
- •13. Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
- •14. Patients with severe heart failure or congestive heart failure of needing drug therapy
- •15. Patients with liver disease
- •16. Patients with severe renal disease
- •17. Patients with diabetes mellitus with ketoacidosis, diabetes coma and prior
- •18. Patients before or after surgery, with severe infections, severe trauma
- •19. Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •20. Patients with renal disease or renal failure caused by cardiovascular collapse, acute myocardial infarction, sepsis (Serum creatinine = 1.5mg/dL or abnormal creatinie clearance)
- •21 Patients who had a test to injecting radioactive iodine in vein
- •22. Patients with severe infections or severe traumatic whole body injuries
- •23. Patients with undernourishment condition or starvation state or hyposthenia or hypopituitarism, or hypoadrenalism
- •24. Patients with respiratory failure, or stomach disease
- •25. Subjects who is not able to intake high fat meals
- •26. Subjects who is not able to comply with guidelines described in the protocol.
- •27. Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
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