The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple 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 : HL151. 1T, once a day oral administration, for 4 days
Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days
The Korea Univertisy Anam Hospital
Seoul, South Korea
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
Time frame: 24 hours after 4 days' repeated dosing
Maximum the plasma concentration during a dosing interval(Cmax,ss)
Time frame: 24 hours after 4 days' repeated dosing
Number of participants with adverse events
Time frame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
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