Clinical Trials/NCT03346187

NCT03346187

Completed

Phase 1

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

Chong Kun Dang Pharmaceutical1 site in 1 country60 target enrollmentMay 19, 2017

ConditionsDyslipidemias

InterventionsActive Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)Test drug(CKD-337)

DrugsActive Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)Test drug(CKD-337)

Overview

Phase: Phase 1
Intervention: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)
Conditions: Dyslipidemias
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 60
Locations: 1
Primary Endpoint: Atorvastatin AUCt(Area under the plasma drug concentration-time curve)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

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(Atorvastatin Calcium Trihydrate+Fenofibrate). Each treatment period was separated by a washout period of at least 7 days.

Registry

clinicaltrials.gov

Start Date

May 19, 2017

End Date

June 13, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)

Arms & Interventions

A

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.

Intervention: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)

A

Intervention: Test drug(CKD-337)

B

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.

Intervention: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)

B

Intervention: Test drug(CKD-337)

Outcomes

Primary Outcomes

Atorvastatin AUCt(Area under the plasma drug concentration-time curve)

Time Frame: 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

Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

Atorvastatin Cmax(Maximum plasma concentration)

Time Frame: 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

Time Frame: 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

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)
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 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)
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)
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)
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)
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 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 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)
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)
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 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 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)