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OpenTrials
Completed

NCT Number: NCT03200496

Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus 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

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-5206(Fasting)

Drug

Test drug l : DA-5206(Fasting)

DA-5206(Fed)

Drug

Test drug ll : DA-5206(Fed)

TALION®

Drug

Reference drug : Talion®

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: 0~24hr

    PK Parameter

  2. Peak Plasma Concentration (Cmax)

    Time frame: 0~24hr

    PK Parameter

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2017
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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