A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Lipitor + Lipidil supra; Drug: CKD-337

• Registration Number: NCT02651753
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Lipitor + Lipidil supra	Period 1: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions. Period 2: Test drug(CKD-337), 1 capsule administered under fed conditions.
B	Lipitor + Lipidil supra	Period 1: Test drug(CKD-337), 1 capsule administered under fed conditions. Period 2: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
B	CKD-337	Period 1: Test drug(CKD-337), 1 capsule administered under fed conditions. Period 2: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.
A	CKD-337	Period 1: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions. Period 2: Test drug(CKD-337), 1 capsule administered under fed conditions.

Primary Outcome Measures

Name	Time	Method
Atorvastatin Cmax	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
Fenofibric acid AUCt	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Atorvastatin AUCt	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
Fenofibric acid Cmax	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

Secondary Outcome Measures

Name	Time	Method
Atorvastatin t1/2	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
Atorvastatin AUCinf	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
Atorvastatin Tmax	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
Atorvastatin CL/F	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
Atorvastatin Vd/F	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
Fenofibric acid AUCinf	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Fenofibric acid Tmax	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Fenofibric acid t1/2	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Fenofibric acid CL/F	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
Fenofibric acid Vd/F	Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration
2-hydroxy atorvastatin AUCt	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
2-hydroxy atorvastatin Tmax	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
2-hydroxy atorvastatin Cmax	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
2-hydroxy atorvastatin AUCinf	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
2-hydroxy atorvastatin CL/F	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
2-hydroxy atorvastatin Vd/F	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
2-hydroxy atorvastatin t1/2	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