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
- 60
- 试验地点
- 1
- 主要终点
- Atorvastatin AUCt(Area under the plasma drug concentration-time curve)
研究概览
简要总结
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
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(Atorvastatin Calcium Trihydrate+Fenofibrate).
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male older than 19 years and under 45 years at the time of screening
- •BMI 17.5~30.5 kg/m² and body weight more than 55kg
- •BMI = Weight(kg)/{Height(m)}²
- •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 etc.), Vital Sign, ECG test at the time of screening
- •Subject who fully understand the clinical trials after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willing
排除标准
- •Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has a following history
- •Gallbladder disease including cholelithiasis, severe hepatic impairment
- •Acute/chronic pancreatitis due to hypertriglyceridemia
- •Pulmonary embolism or interstitial lung disease
- •Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Hypoalbuminemia
- •Alcoholics
- •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 in the EKG at the time of screening
- •QTc(Q-T interval corrected for heart rate) > 450ms
- •PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec
- •QRS duration(The duration of the Q,R and S wave in ECG) > 120msec
- •The following results in the clinical laboratory tests
- •CPK(Creatinine Phospho-Kinase) > 2 x upper limit of normal range
- •Liver function test(AST; Aspartate Transaminase, ALT; Alanine Transaminase, ALP; Alkaline phosphatase, Total bilirubin, γ-GT) > 2 x upper limit of normal range
- •eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)
- •Systolic blood pressure ≥ 160mmHg(millimeter of mercury) or ≤ 100mmHg(millimeter of mercury) , Diastolic blood pressure ≥ 95mmHg(millimeter of mercury) or ≤ 60mmHg(millimeter of mercury) at the time of screening
- •History of drug abuse or a positive reaction for drug abuse in the urine at the time of screening
- •Taking medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days of the first dosing
- •Those who experience photoallergy or phototoxicity during treatment with fibrates or ketoprofen
- •Taking ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days 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, component blood donation or blood transfusion within 1 month before the first dosing
- •Alcohol > 21 units/week (1unit=10g of pure alcohol), continuously within 6 month before the first dosing or Who can not stop drinking alcohol during the clinical trial
- •Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial
- •Consumption of food containing grapefruit within 48 hours before first dosing and who can not stop consumption it until EOS(End of study)
- •Consumption of food containing caffeine(e.g. coffee, green tea etc.) within 24 hours before first dosing and who can not stop consumption it until discharge
- •Not using a reliable contraception or planning a pregnancy during the clinical trial
- •Unsuitable Conditions including laboratory result by investigator's judgement
研究组 & 干预措施
A
Period 1: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.
Period 2: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.
干预措施: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) (Drug)
A
Period 1: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.
Period 2: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.
干预措施: Test drug(CKD-337) (Drug)
B
Period 1: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.
Period 2: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.
干预措施: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) (Drug)
B
Period 1: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.
Period 2: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.
干预措施: Test drug(CKD-337) (Drug)
结局指标
主要结局
Atorvastatin AUCt(Area under the plasma drug concentration-time curve)
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
Atorvastatin Cmax(Maximum plasma concentration)
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
次要结局
- 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)
- Atorvastatin AUCinf(Area under plasma concentration-time curve from time point of administration to infinite)(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(Terminal half-life, Time for Cmax to drop in half)(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 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)
- Atorvastatin Tmax(Time taken to reach the maximum concentration)(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 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)
- 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 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(Apparent total body clearance after extravascular administration, calculated as Dose/AUC)(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(Apparent volume of distribution/Bioavailability)(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)
- 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 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 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)