NCT02682745

Single Dosing Clinical Trial of HL151

Single Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	HL151	Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
DRUG	TALION tab.	Reference drug: TALION tab, 1T, every 12 hours, oral administration

Timeline

• Start date: 2016-01-15
• Primary completion: 2016-02-12
• Completion: 2016-02-12
• First posted: 2016-02-15
• Last updated: 2018-08-17

Locations

1 site across 1 country: South Korea