The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic properies of tamsulosin
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects Subjects will receive repeated dose of tamsulosin (0.2mg\*1t/day) or tamsulosin (0.2mg\*1t/day) / tadalafil (5mg\*1t/day) for 5days Each treatment period was separated by a washout period of at least 10 days. Each period of study will enroll 14 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Chonbuk National University Hospital
Jeonju, South Korea
Tamsulosin AUCt(0-24)
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin Cmax
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin Css,min
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin Css,av
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin Tss,max
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin t1/2
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin CL/F
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin Vd/F
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin fluctuation[(Css,max-Css,min)/Css,av]
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
Tamsulosin swing[(Css,max-Css,min)/Css,min]
Time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
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