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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TALION®; Drug: DA-5206(Fasting); Drug: DA-5206(Fed)

• Registration Number: NCT03200496
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-29
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TALION®	TALION®	-
DA-5206(Fasting)	DA-5206(Fasting)	-
DA-5206(Fed)	DA-5206(Fed)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of