The Korea Univertisy Anam Hospital
Seoul, 136-705, South Korea
NCT Number: NCT02686294
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.
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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 : HL151. 1T, once a day oral administration, for 4 days
Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days
Time frame: 24 hours after 4 days' repeated dosing
Time frame: 24 hours after 4 days' repeated dosing
Time frame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
Hanlim Pharm. Co., Ltd.
Industry
Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
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