Overview
A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337
Status:
Completed
Completed
Trial end date:
2016-05-01
2016-05-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Chong Kun Dang PharmaceuticalTreatments:
Atorvastatin
Atorvastatin Calcium
Calcium
Calcium, Dietary
Fenofibrate
Criteria
Inclusion Criteria:1. Healthy male older than 19 years at the time of screening
2. BMI 17.5~30.5 kg/m2 and body weight more than 55kg
3. Subject who is no chronic disease, no symptoms or pathological findings
4. 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
5. Subject who fully understand the clinical trials after in-depth explanation, decided
to join the clinical trials by their will and signed inform consent
Exclusion Criteria:
1. 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
2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery
which can affect drug absorption
3. Subject who has hypersensitivity to the drug composition containing choline
fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series,
antibiotic and so on)
4. The following clinical significant findings at the time of screening
- QTc > 450ms
- PR interval > 200msec
- QRS duration > 120msec
5. 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
6. Systolic blood pressure ≥ 160mmHg or ≤ 100mmHg, Diastolic blood pressure ≥ 95mmHg or ≤
60mmHg at the time of screening
7. History of drug abuse or a positive reaction for drug abuse at the screening test for
urine
8. Taking ETC, oriental medicine within 2 weeks and OTC, vitamin within 1 week before the
first dosing
9. Taking the medication involved in other clinical trials within 3 months before the
first dosing
10. Whole blood donation with 2 months or component blood donation within 1 month or blood
transfusion within 1 month before the first dosing
11. Alcohol > 21 units/week (1unit=10g of pure alcohol), within 6 month before the first
dosing
12. Smoker(> 10 cigarettes/day) for the last 3 months
13. Comsumption of grapefruit of food containing grapefruit during clinical trial period
from first dosing 48hours ago
14. Comsumption of food containing caffeine(e.g. coffee, green tea) during 24 hours ago IP
dosing at discharge
15. Not using a reliable contraception, planning a pregnancy during the study
16. An impossible one who participates in clinical trial by investigator's decision
including laboratory test result