Status:
COMPLETED
A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Dyslipidemias
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
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 CK...
Eligibility Criteria
Inclusion
- 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.
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 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
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03382756
Start Date
October 12 2017
End Date
November 7 2017
Last Update
December 27 2017
Active Locations (1)
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1
Dong-A University Hospital
Busan, Seo-gu, South Korea, 602-812