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Repeated Dosing Clinical Trial of HL151

NCT02686294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Rhinitis, Allergic, Perennial

Interventions

DRUG

HL151

Test drug : HL151. 1T, once a day oral administration, for 4 days

DRUG

TALION tab.

Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ji young Park, MD · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2016-03-15
Completion
2016-03-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02686294 on ClinicalTrials.gov