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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TALION®; Drug: DA-5206(Fasting); Drug: DA-5206(Fed)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TALION®	Drug: TALION®; Reference drug : Talion®
Experimental: DA-5206(Fasting)	Drug: DA-5206(Fasting); Test drug l : DA-5206(Fasting)
Experimental: DA-5206(Fed)	Drug: DA-5206(Fed); Test drug ll : DA-5206(Fed)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2017
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DA5206_BE_Ⅰ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No