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

Dyslipidemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651753
• Other study ID #: 146BE15025
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2016
• Last updated: July 5, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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, ?-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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Lipitor + Lipidil supra
Reference Drug: Lipitor + Lipidil supra
• CKD-337
Test Drug: CKD-337

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No