A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D745 and D150
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety after Oral Administration of D745, D150 and CKD-501 in Healthy Adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Severance Hospital
Seoul, South Korea
Cmax,ss of CKD-501, D745, D150
Cmax,ss: Maximum concentration of drug in plasma at steady state
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
AUCtau,ss of CKD-501, D745, D150
AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Cmin,ss of CKD-501, D745, D150
Cmin,ss: Minimum concentration of drug in plasma at steady state
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Tmax,ss of CKD-501, D745, D150
Tmax,ss: Time to maximum plasma concentration at steady state
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
CLss/F of CKD-501, D745, D150
CLss/F: Apparent Clearance at steady state
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Fluctuation of CKD-501, D745, D150
Fluctuation: Peak trough fluctuation within one dosing interval
Time frame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
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