The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
Reference drug: TALION tab, 1T, every 12 hours, oral administration
The Korea Univertisy Anam Hospital
Seoul, South Korea
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 hours after single administration
Peak Plasma Concentration (Cmax)
Time frame: 24 hours after single administration
Number of participants with adverse events
Time frame: Participants will be followed for the duration of study medication dosing days and hospital stay, and follow-up period for maximum 5 days from the discharge
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