Status:
COMPLETED
A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Dyslipidemias
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03346187
Start Date
May 19 2017
End Date
June 13 2017
Last Update
December 19 2017
Active Locations (1)
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1
Dong-A University Hospital
Busan, Seo-gu, South Korea, 602-812