Phase 1 trial to evaluate the drug drug interaction of CKD-501 and D308
A randomized, open-label, multiple dose, 2-way crossover study to evaluate the drug drug interaction of CKD-501 and D308 in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
1. D308 2. CKD-501: Lobeglitazone sulfate 0.5mg
Chonbuk National University Hospital
Jeonju, South Korea
(Part 1) AUCss,tau of D308
Area under the curve of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Css,max of D308
Max Concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) AUCss,tau of CKD-501
Area under the curve of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Css,max of CKD-501
Max Concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Css,min of D308
Min concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Css,av of D308
average concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Tss,max of D308
time of Max concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
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(Part 1) t1/2 of D308
half-life time of D308
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) CLss/F of D308
Apparent clearance of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Vdss/F of D308
Apparent volume of distribution of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Fluctuation[(Css,max-Css,min)/Css,av] of D308
Fluctuation concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 1) Swing[(Css,max-Css,min)/Css,min] of D308
Swing concentration of D308 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Css,min of CKD-501
Min concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Css,av of CKD-501
average concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Tss,max of CKD-501
time of Max concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) t1/2 of CKD-501
half-life time of CKD-501
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) CLss/F of CKD-501
Apparent clearance of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Vdss/F of CKD-501
Apparent volume of distribution of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Fluctuation[(Css,max-Css,min)/Css,av] of CKD-501
Fluctuation concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
(Part 2) Swing[(Css,max-Css,min)/Css,min] of CKD-501
Swing concentration of CKD-501 at steady state
Time frame: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours