A Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 After a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC0-t of Atorvastatin
研究概览
简要总结
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
详细描述
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.
Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.
Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.
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 subjects between the ages of 19 and 45 years
- •Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
- •Subject who doesn't have chronic disease, pathological symptoms or findings
- •Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
- •Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.
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 medical histories listed below.
- •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 drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics
- •Subject who has 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 QRS wave in ECG) > 120msec
- •Subject whose results of the clinical laboratory tests are included in the following categories
- •CPK(Creatinine Phospho-Kinase) > 2x upper limit of normal range
- •Liver function test (AST;Aspartate Transaminase, ALT;Alanine Transaminase, ALP;Alkaline phosphatase, Total bilirubin, γ-GT;Gamma-Glutamyl Transferase) > 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 examined by urinalysis at the time of screening
- •Subject who took medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days prior to the first dose of medication
- •Those who has experienced photoallergy or phototoxicity during treatment with fibrates or ketoprofen
- •Subject who took ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days prior to the first dose of medication
- •Subject who took the medication involved in other clinical trials within 3 months prior to the first dose of medication
- •Subject who donated whole conducted blood donation within 2 months or component blood donation or blood transfusion within 1 month prior to the first dose of medication
- •Subject who drinks alcohol more than 21 units per a week (1unit=10g of pure alcohol) continuously within 6 month prior to the first dose of medication 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
- •Subject who consumed food containing grapefruit within 48 hours prior to the first dose of medication or who can not stop consumption it until EOS(End of study)
- •Subject who consumed food containing caffeine(e.g. coffee, green tea etc.) within 24 hours prior to the first dose of medication or who can not stop consumption it until discharge
- •Subject who do not use a reliable contraception or who plans a pregnancy during the clinical trial
- •Subject who has unsuitable conditions decided by investigator's judgement including clinical laboratory result
研究组 & 干预措施
Group A
Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition
Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition
干预措施: High fat diet (Dietary Supplement)
Group A
Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition
Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition
干预措施: CKD-337 (Drug)
Group B
Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition
Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition
干预措施: High fat diet (Dietary Supplement)
Group B
Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition
Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition
干预措施: CKD-337 (Drug)
结局指标
主要结局
AUC0-t of Atorvastatin
时间窗: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration
Cmax of Fenofibric acid
时间窗: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Maximum plasma concentration of Fenofibric acid
Cmax of Atorvastatin
时间窗: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Maximum plasma concentration of Atorvastatin
AUCt of Fenofibric acid
时间窗: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration
次要结局
- CL/F of Atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Vd/F of Atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- AUCinf of Fenofibric acid(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration)
- T 1/2 of Fenofibric acid(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration)
- AUC0-t of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- AUCinf of Atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- T 1/2 of Atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Tmax of Fenofibric acid(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration)
- Cmax of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Tmax of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Vd/F of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- CL/F of Fenofibric acid(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration)
- CL/F of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Tmax of Atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- Vd/F of Fenofibric acid(Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration)
- AUCinf of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)
- T 1/2 of 2-hydroxy atorvastatin(Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration)