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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Atorvastatin AUCt
研究概览
简要总结
This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.
详细描述
This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.
Subjects will receive either a single oral dose of the test formulation(CKD-337) or a oral dose of the reference formulation(Lipitor+Lipidil supra).
Each treatment period was separated by a washout period of at least 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male older than 19 years at the time of screening
- •BMI 17.5~30.5 kg/m2 and body weight more than 55kg
- •Subject who is no chronic disease, no symptoms or pathological findings
- •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
- •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
- •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
- •Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- •Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
- •The following clinical significant findings at the time of screening
- •QTc > 450ms
- •PR interval > 200msec
- •QRS duration > 120msec
- •The following results in the clinical laboratory tests
- •CPK > 2 x upper limit of normal range
- •Liver function test (AST, ALT, ALP, Total bilirubin, γ-GT) > 2 x upper limit of normal range
- •eGFR(estimated GFR) < 60 mL/min/1.73m2
- •Systolic blood pressure ≥ 160mmHg or ≤ 100mmHg, Diastolic blood pressure ≥ 95mmHg or ≤ 60mmHg at the time of screening
- •History of drug abuse or a positive reaction for drug abuse at the screening test for urine
- •Taking ETC, oriental medicine within 2 weeks and OTC, vitamin within 1 week before the first dosing
- •Taking the medication involved in other clinical trials within 3 months before the first dosing
- •Whole blood donation with 2 months or component blood donation within 1 month or blood transfusion within 1 month before the first dosing
- •Alcohol > 21 units/week (1unit=10g of pure alcohol), within 6 month before the first dosing
- •Smoker(> 10 cigarettes/day) for the last 3 months
- •Comsumption of grapefruit of food containing grapefruit during clinical trial period from first dosing 48hours ago
- •Comsumption of food containing caffeine(e.g. coffee, green tea) during 24 hours ago IP dosing at discharge
- •Not using a reliable contraception, planning a pregnancy during the study
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
A
Period 1: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
Period 2: Test drug(CKD-337), 1 capsule administered under fed conditions.
干预措施: Lipitor + Lipidil supra (Drug)
A
Period 1: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
Period 2: Test drug(CKD-337), 1 capsule administered under fed conditions.
干预措施: CKD-337 (Drug)
B
Period 1: Test drug(CKD-337), 1 capsule administered under fed conditions. Period 2: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
干预措施: Lipitor + Lipidil supra (Drug)
B
Period 1: Test drug(CKD-337), 1 capsule administered under fed conditions. Period 2: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
干预措施: CKD-337 (Drug)
结局指标
主要结局
Atorvastatin AUCt
时间窗: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration
Fenofibric acid Cmax
时间窗: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Atorvastatin Cmax
时间窗: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration
Fenofibric acid AUCt
时间窗: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
次要结局
- Fenofibric acid AUCinf(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration)
- Fenofibric acid Tmax(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration)
- Atorvastatin AUCinf(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- Atorvastatin Tmax(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- Atorvastatin t1/2(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- Atorvastatin CL/F(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- Atorvastatin Vd/F(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- Fenofibric acid t1/2(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration)
- Fenofibric acid CL/F(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration)
- Fenofibric acid Vd/F(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration)
- 2-hydroxy atorvastatin AUCt(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin Tmax(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin Cmax(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin AUCinf(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin CL/F(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin Vd/F(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)
- 2-hydroxy atorvastatin t1/2(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration)