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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03200496

Enrollment

Registered

2017-06-27

Start date

2017-05-29

Completion date

2017-06-29

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGDA-5206(Fasting)

Test drug l : DA-5206(Fasting)

DRUGDA-5206(Fed)

Test drug ll : DA-5206(Fed)

DRUGTALION®

Reference drug : Talion®

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	0~24hr	PK Parameter
Area under the plasma concentration versus time curve (AUC)	0~24hr	PK Parameter

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026