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Single Dosing Clinical Trial of HL151 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02682745•Hanlim Pharm. Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male volunteer in the age of 19-45
•2. Body weight≥50kg and BMI 18\~29 kg/m2
•3. Subject who sign on an informed consent form willingly

Exclusion Criteria

•1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
•2. Subject with acute disease within 28 days prior to study medication dosing
•3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
•4. Subject with clinically significant chronic disease
•5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
•6. Use of any prescription medication within 14 days prior to study medication dosing
•7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
•8. Subject with clinically significant allergic disease
•9. Subject with known for hypersensitivity reaction to bepotastine
•10. Subject with any of the following conditions in laboratory test
+17 more criteria

Locations (1)

The Korea Univertisy Anam Hospital

Seoul, South Korea

Key Dates

Start Date

January 15, 2016

Primary Completion Date

February 12, 2016

Completion Date

February 12, 2016

Last Updated

August 17, 2018

Enrollment

ACTUAL participants

Conditions

Rhinitis, Allergic, Perennial

Interventions

HL151

DRUG

TALION tab.

DRUG

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Dosing Clinical Trial of HL151

Inclusion Criteria

Exclusion Criteria

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

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