The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.
Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
* 1 capsule, oral, once daily, 7days * over the period I\&II(crossover)
* 1 tablet, oral, once daily, 7days * over the period I\&II(crossover)
Kyungpook National University Hospital Clinical Trial Center
Daegu, Eok-dong 2(i)-ga Jung-gu, South Korea
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf
AUCinf: Area Under the Concentration time curve with the last concentration extrapolated based on the elimination rate constant Kel
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max
Css,max : Maximum drug concentration in plasma determined directly from individual concentration-time data
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min
Css,min : Minimum drug concentration in plasma determined directly from individual concentration-time data
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max
Tss,max : Time to reach maximum drug concentration in plasma calculated from \[plasma\] versus time profiles
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½
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t½ : Observed terminal elimination half-life
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
Number of participants with adverse events
* Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG * adverse event monitoring
Time frame: From 1day to 37 days