NCT03200496

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2017

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1 month

First QC Date

June 26, 2017

Last Update Submit

July 6, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC)

    PK Parameter

    0~24hr

  • Peak Plasma Concentration (Cmax)

    PK Parameter

    0~24hr

Study Arms (3)

TALION®

EXPERIMENTAL
Drug: TALION®

DA-5206(Fasting)

EXPERIMENTAL
Drug: DA-5206(Fasting)

DA-5206(Fed)

EXPERIMENTAL
Drug: DA-5206(Fed)

Interventions

DA-5206(Fasting)DRUG

Test drug l : DA-5206(Fasting)

DA-5206(Fasting)
DA-5206(Fed)DRUG

Test drug ll : DA-5206(Fed)

DA-5206(Fed)
TALION®DRUG

Reference drug : Talion®

TALION®

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 27, 2017

Study Start

May 29, 2017

Primary Completion

June 29, 2017

Study Completion

June 29, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

KR(1)