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

NCT ID: NCT02651753

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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.

Group Type: EXPERIMENTAL

Lipitor + Lipidil supra

Intervention Type: DRUG

Reference Drug: Lipitor + Lipidil supra

CKD-337

Intervention Type: DRUG

Test Drug: CKD-337

B

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.

Group Type: EXPERIMENTAL

Lipitor + Lipidil supra

Intervention Type: DRUG

Reference Drug: Lipitor + Lipidil supra

CKD-337

Intervention Type: DRUG

Test Drug: CKD-337

Interventions

Lipitor + Lipidil supra

Reference Drug: Lipitor + Lipidil supra

Intervention Type: DRUG

CKD-337

Test Drug: CKD-337

Intervention Type: DRUG

Other Intervention Names

Lipitor(Atorvastatin calcium trihydrate 21.70mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet); CKD-337(Atorvastatin calcium trihydrate 21.70mg+Cholinfe fenofibrate 178.8mg/capsule)

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

146BE15025

Identifier Type: -

Identifier Source: org_study_id