Clinical trial NCT02651753: A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 single oral dose of the test formulation(CKD-337) or a oral dose of the reference formulation(Lipitor+Lipidil supra).

Each treatment period was separated by a washout period of at least 7 days.

Eligibility 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

Primary outcomes:
measure: Atorvastatin AUCt
timeFrame: 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
measure: Atorvastatin Cmax
timeFrame: 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
measure: Fenofibric acid AUCt
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: Fenofibric acid Cmax
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Secondary outcomes:
measure: Atorvastatin AUCinf
timeFrame: 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
measure: Atorvastatin Tmax
timeFrame: 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
measure: Atorvastatin t1/2
timeFrame: 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
measure: Atorvastatin CL/F
timeFrame: 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
measure: Atorvastatin Vd/F
timeFrame: 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
measure: Fenofibric acid AUCinf
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: Fenofibric acid Tmax
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: Fenofibric acid t1/2
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: Fenofibric acid CL/F
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: Fenofibric acid Vd/F
timeFrame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
measure: 2-hydroxy atorvastatin AUCt
timeFrame: 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
measure: 2-hydroxy atorvastatin Cmax
timeFrame: 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
measure: 2-hydroxy atorvastatin AUCinf
timeFrame: 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
measure: 2-hydroxy atorvastatin Tmax
timeFrame: 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
measure: 2-hydroxy atorvastatin t1/2
timeFrame: 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
measure: 2-hydroxy atorvastatin CL/F
timeFrame: 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
measure: 2-hydroxy atorvastatin Vd/F
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: