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

NCT03346187 | Completed Phase 1

• 1 other identifier: 146BE16007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (4)

• 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]

• 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

• 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

• 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 Outcomes (17)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

A

EXPERIMENTAL

Period 1: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions. Period 2: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.

Drug: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate); Drug: Test drug(CKD-337)

B

EXPERIMENTAL

Period 1: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions. Period 2: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.

Drug: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate); Drug: Test drug(CKD-337)

Interventions

Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) DRUG

Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)

A; B

Test drug(CKD-337) DRUG

CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)

A; B

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male older than 19 years and under 45 years at the time of screening
• BMI 17.5\~30.5 kg/m² and body weight more than 55kg
• BMI = Weight(kg)/{Height(m)}²
• Subject who is no chronic disease, no symptoms or pathological findings
• Suitable subject who is determined by laboratory tests(hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
• 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

You may not qualify if:

• 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
• Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
• Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
• 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
• The following results in the clinical laboratory tests

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Dong-A University Hospital

Busan, Seo-gu, 602-812, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: May 19, 2017
• Primary Completion: May 31, 2017
• Study Completion: June 13, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

KR (1)