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

Dyslipidemias 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: NCT03346187
• Other study ID #: 146BE16007
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2017
• Last updated: December 17, 2017
• Start date: May 19, 2017
• Est. completion date: June 13, 2017

Study information

• Verified date: December 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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(Atorvastatin Calcium Trihydrate+Fenofibrate).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 13, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

• Inclusion Criteria:

1. Healthy male older than 19 years and under 45 years at the time of screening

2. BMI 17.5~30.5 kg/m² and body weight more than 55kg

• BMI = Weight(kg)/{Height(m)}²

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 etc.), Vital Sign, ECG test at the time of screening

5. Subject who fully understand the clinical trials after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willing

• Exclusion Criteria:

1. Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has a following history

• Gallbladder disease including cholelithiasis, severe hepatic impairment

• Acute/chronic pancreatitis due to hypertriglyceridemia

• Pulmonary embolism or interstitial lung disease

• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Hypoalbuminemia

• Alcoholics

• 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 in the EKG at the time of screening

• QTc(Q-T interval corrected for heart rate) > 450ms

• PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec

• QRS duration(The duration of the Q,R and S wave in ECG) > 120msec

5. The following results in the clinical laboratory tests

• CPK(Creatinine Phospho-Kinase) > 2 x upper limit of normal range

• Liver function test(AST; Aspartate Transaminase, ALT; Alanine Transaminase, ALP; Alkaline phosphatase, Total bilirubin, ?-GT) > 2 x upper limit of normal range

• eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)

6. Systolic blood pressure = 160mmHg(millimeter of mercury) or = 100mmHg(millimeter of mercury) , Diastolic blood pressure = 95mmHg(millimeter of mercury) or = 60mmHg(millimeter of mercury) at the time of screening

7. History of drug abuse or a positive reaction for drug abuse in the urine at the time of screening

8. Taking medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days of the first dosing

9. Those who experience photoallergy or phototoxicity during treatment with fibrates or ketoprofen

10. Taking ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days before the first dosing

11. Taking the medication involved in other clinical trials within 3 months before the first dosing

12. Whole blood donation with 2 months, component blood donation or blood transfusion within 1 month before the first dosing

13. Alcohol > 21 units/week (1unit=10g of pure alcohol), continuously within 6 month before the first dosing or Who can not stop drinking alcohol during the clinical trial

14. Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial

15. Consumption of food containing grapefruit within 48 hours before first dosing and who can not stop consumption it until EOS(End of study)

16. Consumption of food containing caffeine(e.g. coffee, green tea etc.) within 24 hours before first dosing and who can not stop consumption it until discharge

17. Not using a reliable contraception or planning a pregnancy during the clinical trial

18. Unsuitable Conditions including laboratory result by investigator's judgement

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)
Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)
• Test drug(CKD-337)
CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan	Seo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atorvastatin AUCt(Area under the plasma drug concentration-time curve)		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]
Primary	Atorvastatin Cmax(Maximum plasma concentration)		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
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
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
Secondary	Atorvastatin AUCinf(Area under plasma concentration-time curve from time point of administration to infinite)		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
Secondary	Atorvastatin Tmax(Time taken to reach the maximum concentration)		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
Secondary	Atorvastatin t1/2(Terminal half-life, Time for Cmax to drop in half)		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
Secondary	Atorvastatin CL/F(Apparent total body clearance after extravascular administration, calculated as Dose/AUC)		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
Secondary	Atorvastatin Vd/F(Apparent volume of distribution/Bioavailability)		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
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
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
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
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
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
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
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
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
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
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
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
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