This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Harnal-D Tab. 1T single oral administration after meal
Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration after meal
Bestian Hospital
Osŏng, South Korea
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 hours
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 hours
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