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

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: DA-5206(Fed)

Drug: TALION®

Drug: DA-5206(Fasting)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03200496

DA5206_BE_Ⅰ

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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