The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.
The study is an Open-label, Phase I, drug-drug interaction study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
43
Subjects will receive IY001 once daily for 3 days, followed by co-administration of IY001 and IY002 once daily for 5 days.
Subjects will receive IY002 once daily for 5 days, followed by co-administration of IY001 and IY002 once daily for 3 days.
H plus Yangji Hospital
Seoul, Seoul, South Korea
Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
The total drug exposure of finasteride over the dosing interval at steady state.
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
Finasteride Maximum Plasma Concentration at steady state (Cmax,ss)
The peak plasma concentration of finasteride observed at steady state.
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
Tamsulosin Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
The total drug exposure of tamsulosin over the dosing interval at steady state.
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
Tamsulosin Maximum Plasma Concentration at steady state (Cmax,ss)
The peak plasma concentration of tamsulosin observed at steady state.
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
Finasteride Time to Maximum Plasma Concentration at steady state (Tmax,ss)
Time to reach the maximum plasma concentration of finasteride measured from plasma samples collected at pre-dose and multiple post-dose time points on Days 3 and 8.
Time frame: Days 3 and 8
Finasteride Elimination Half-Life at Steady State (t1/2,ss)
The elimination half-life of finasteride calculated using plasma concentrations from serial blood samples collected up to 24 hours post-dose on Days 3 and 8.
Time frame: Days 3 and 8
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Finasteride Apparent Clearance at Steady State (CLss/F)
Apparent clearance of finasteride derived from plasma concentration-time data obtained from serial blood sampling on Days 3 and 8.
Time frame: Days 3 and 8
Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)
Minimum plasma concentration measured from pre-dose (0 hour) samples collected on Days 1, 2, 7, and 8.
Time frame: Days 1, 2, 7, and 8
Finasteride Average Plasma Concentration at Steady State (Cav,ss)
Average plasma concentration calculated over the dosing interval from serial samples collected on Days 3 and 8.
Time frame: Days 3 and 8
Finasteride Accumulation Ratio (R)
Ratio of plasma concentrations comparing steady state (Day 8) to earlier dosing period (Day 3).
Time frame: Days 3 and 8
Finasteride Peak-Trough Fluctuation (PTF)
Fluctuation between peak (Cmax) and trough (Cmin) plasma concentrations calculated from serial sampling on Days 3 and 8.
Time frame: Days 3 and 8
Tamsulosin Time to Maximum Plasma Concentration at Steady State (Tmax,ss)
Time to reach the maximum plasma concentration of tamsulosin measured from plasma samples collected at pre-dose and multiple post-dose time points on Days 5 and 8.
Time frame: Days 5 and 8
Tamsulosin Elimination Half-Life at Steady State (t1/2,ss)
Elimination half-life calculated from plasma concentrations obtained up to 24 hours post-dose on Days 5 and 8.
Time frame: Days 5 and 8
Tamsulosin Apparent Clearance at Steady State (CLss/F)
Apparent clearance derived from plasma concentration-time data on Days 5 and 8.
Time frame: Days 5 and 8
Tamsulosin Minimum Plasma Concentration at Steady State (Cmin,ss)
Minimum plasma concentration measured from pre-dose samples collected on Days 1, 4, 7, and 8.
Time frame: Days 1, 4, 7, and 8
Tamsulosin Average Plasma Concentration at Steady State (Cav,ss)
Average plasma concentration over dosing interval calculated from serial samples on Days 5 and 8.
Time frame: Days 5 and 8
Tamsulosin Accumulation Ratio (R)
Ratio of plasma concentrations comparing steady state (Day 8) to earlier dosing period (Day 5).
Time frame: Days 5 and 8
Tamsulosin Peak-Trough Fluctuation (PTF)
Fluctuation between peak (Cmax) and trough (Cmin) plasma concentrations from serial sampling on Days 5 and 8.
Time frame: Days 5 and 8