A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337. Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337. Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa. Each treatment period was separated by a washout period of at least 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
A diet consisting of more than 900kcal and 35% of fat
Test Drug
Dong-A University Hospital
Busan, Seo-gu, South Korea
AUC0-t of Atorvastatin
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Cmax of Atorvastatin
Maximum plasma concentration of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCt of Fenofibric acid
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Cmax of Fenofibric acid
Maximum plasma concentration of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
AUCinf of Atorvastatin
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time infinity
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of Atorvastatin
Time to maximum concentration of of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of Atorvastatin
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Apparent terminal half-life of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of Atorvastatin
Total body clearance of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of Atorvastatin
Apparent volume of distribution of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of Fenofibric acid
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time infinity
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Tmax of Fenofibric acid
Time to maximum concentration of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
T 1/2 of Fenofibric acid
Apparent terminal half-life of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
CL/F of Fenofibric acid
Total body clearance of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Vd/F of Fenofibric acid
Apparent volume of distribution of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
AUC0-t of 2-hydroxy atorvastatin
Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time of last quantifiable concentration
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Cmax of 2-hydroxy atorvastatin
Maximum concentration attained of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of 2-hydroxy atorvastatin
Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time infinity
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of 2-hydroxy atorvastatin
Time to maximum concentration 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of 2-hydroxy atorvastatin
Apparent terminal half-life of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of 2-hydroxy atorvastatin
Total body clearance of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of 2-hydroxy atorvastatin
Apparent volume of distribution of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration