Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2017-06-29

Brief Summary

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This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TALION®

Group Type EXPERIMENTAL

TALION®

Intervention Type DRUG

Reference drug : Talion®

DA-5206(Fasting)

Group Type EXPERIMENTAL

DA-5206(Fasting)

Intervention Type DRUG

Test drug l : DA-5206(Fasting)

DA-5206(Fed)

Group Type EXPERIMENTAL

DA-5206(Fed)

Intervention Type DRUG

Test drug ll : DA-5206(Fed)

Interventions

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DA-5206(Fasting)

Test drug l : DA-5206(Fasting)

Intervention Type DRUG

DA-5206(Fed)

Test drug ll : DA-5206(Fed)

Intervention Type DRUG

TALION®

Reference drug : Talion®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteer 19 years to 45 years
* Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
* The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate

Exclusion Criteria

* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with acute disease within 28 days before the first dose of Investigational product
* Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
* Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes