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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200496
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Drug: DA-5206(Fasting) Drug: DA-5206(Fed) Drug: TALION® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : June 29, 2017

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)




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200496


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03200496    
Other Study ID Numbers: DA5206_BE_Ⅰ
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No