Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

June 10, 2022 updated by: Dong-A ST Co., Ltd.

An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Siheung-si, Gyeonggi-do, Korea, Republic of, 15079
        • Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Volunteers
  • BMI between 18.0 and 30.0 kg/m2
  • Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Drug: DA-5213 10mg
single dose administration (one tablet once a day)
Drug: DA-5213-R 10mg
single dose administration (one tablet once a day)
Experimental: Sequence B
Drug: DA-5213 10mg
single dose administration (one tablet once a day)
Drug: DA-5213-R 10mg
single dose administration (one tablet once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: [Time Frame: pre-dose~48 hours post-dose]
area under the curve
[Time Frame: pre-dose~48 hours post-dose]
Cmax
Time Frame: [Time Frame: pre-dose~48 hours post-dose]
maximum plasma concentration
[Time Frame: pre-dose~48 hours post-dose]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • BIBE2021-55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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