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

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

Criteria

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