KCT0001787已完成未知
A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers
Chong Kun Dang0 个研究点目标入组 48 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
- 48
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 male older than 19 years at the time of screening
- •2. BMI 17.5~30.5 kg/m2 and body weight more than 55kg
- •2. Subject who is no chronic disease, no symptoms or pathological findings
- •4. Suitable subject who is determined by laboratory tests(hematology test, blood chemistry, urinalysis test) according to the characteristics of the drug and ECG test at the time of screening
- •5. Subject who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent
排除标准
- •1. Subject who has a history of hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases that is clinically significant and who has a following history
- •1) Gallbladder disease including cholelithiasis, severe hepatic impairment
- •2) Acute/chronic pancreatitis due to hypertriglyceridemia
- •3) Pulmonary embolism or interstitial lung disease
- •4) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •5) Hypoalbuminemia
- •6) Alcoholics
- •7) Predisposition to rhabdomyolysis
- •2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- •3. Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
- •4. The following clinical significant findings at the time of screening
- •* QTc > 450ms
- •* PR interval > 200msec
- •* QRS duration > 120msec
- •5. The following results in the clinical laboratory tests
- •* CPK > 2 x upper limit of normal range
- •* Liver function test (AST, ALT, ALP, Total bilirubin, ?-GT) > 2 x upper limit of normal range
- •* eGFR(estimated GFR) < 60 mL/min/1.73m2
- •6. Systolic blood pressure = 160mmHg or = 100mmHg, Diastolic blood pressure = 95mmHg or = 60mmHg at the time of screening
- •7. History of drug abuse or a positive reaction for drug abuse at the screening test for urine
- •8. Taking ETC, oriental medicine within 2 weeks and OTC, vitamin within 1 week before the first dosing
- •9. Taking the medication involved in other clinical trials within 3 months before the first dosing
- •10. Whole blood donation with 2 months or component blood donation within 1 month or blood transfusion within 1 month before the first dosing
- •11. Alcohol > 21 units/week (1unit=10g of pure alcohol), within 6 month before the first dosing
- •12. Smoker(> 10 cigarettes/day) for the last 3 months
- •13. Comsumption of grapefruit of food containing grapefruit during clinical trial period from first dosing 48hours ago
- •14. Comsumption of food containing caffeine(e.g. coffee, green tea) during 24 hours ago IP dosing at discharge
- •15. Not using a reliable contraception, planning a pregnancy during the study
- •16. An impossible one who participates in clinical trial by investigator’s decision including laboratory test result
研究者
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