The Korea Univertisy Anam Hospital
Seoul, 136-705, South Korea
NCT Number: NCT02682745
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.
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Notify Me19 year–45 year
Male
Interventional
Phase 1
Seoul, 136-705, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 hours after single administration
Time frame: 24 hours after single administration
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
Hanlim Pharm. Co., Ltd.
Industry
Single Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
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