A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D759 and D150
A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate Drug-drug Interactions and safety between CKD-501, D759, and D150 in Healthy Adult
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
CHA Bundang Medical Center, CHA University
Seongnam-si, Bundang, South Korea
Cmax,ss of CKD-501, D759, D150
Cmax,ss: Maximum concentration of drug in plasma at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
AUCtau,ss of CKD-501, D759, D150
AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Cmin,ss of CKD-501, D759, D150
Cmin,ss: Minimum concentration of drug in plasma at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Tmax,ss of CKD-501, D759, D150
Tmax,ss: Time to maximum plasma concentration at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
t1/2,ss of CKD-501, D759, D150
t1/2,ss: Terminal half-life at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CLss/F of CKD-501, D759, D150
CLss/F: Apparent Clearance at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Fluctuation of CKD-501, D759, D150
Fluctuation: Peak trough fluctuation within one dosing interval
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Vd,ss/F of CKD-501, D759, D150
Vd,ss/F: Apparent Volume of distribution at steady state
Time frame: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours