A randomized, open-label, two-sequence, two-period, multiple-dose, study to evaluate pharmacokinetic drug-drug interaction, safety and tolerability of UIC202304 and UIC202305 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
* UIC202304 1 Tab/day for 9 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 7 days
* UIC202305 1 Tab/day for 7 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 9 days
Metro Hospital
Anyang-si, Gyeonggi-do, South Korea
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss,τ)
AUCss,τ will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Maximum Plasma Concentration at Steady State (Css,max)
Css,max will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCss,inf)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCss,inf) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Time to Maximum Plasma Concentration at Steady State (Tss,max)
Time to Maximum Plasma Concentration at Steady State (Tss,max) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
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Elimination Half-Life at Steady State (tss,1/2)
Elimination Half-Life at Steady State (tss,1/2) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Minimum Plasma Concentration at Steady State (Css,min)
Minimum Plasma Concentration at Steady State (Css,min) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Apparent Total Body Clearance at Steady State (CLss/F)
Apparent Total Body Clearance at Steady State (CLss/F) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Apparent Volume of Distribution (Vd/F)
Apparent Volume of Distribution (Vd/F) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.
Peak-to-Trough Fluctuation at Steady State (PTF)
Peak-to-Trough Fluctuation at Steady State (PTF) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Time frame: Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.