Clinical Trial of Comparing DA-2902 and DA-2902-R in Healthy Adult Subjects

June 1, 2026 updated by: Dong-A ST Co., Ltd.

An Open-Label, Randomized, Single Oral Dose, Two-Sequence, Two-Period, CrossovSer Bioequivalence Study of "DA-2902" and "DA-2902-R" in Healthy Adults Under Fed Conditions

This study is to compare pharmacokinetics and safety profiles of DA-2902 and DA-2902-R in healthy adult 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

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13520
        • CHA University Bundang Medical Center

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers
  • BMI between 18 and 30 kg/m2
  • Body weight: Male≥50kg, Female≥45kg
  • Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

  • Subjects with clinically significant medical history
  • Subjects with history of drug abuse or addicted
  • Subjects with allergy or drug hypersensitivity

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-2902
single dose administration (DA-2902 one tablet once a day)
Drug: DA-2902-R
single dose administration (DA-2902-R one tablet once a day)
Experimental: Sequence B
Drug: DA-2902
single dose administration (DA-2902 one tablet once a day)
Drug: DA-2902-R
single dose administration (DA-2902-R one tablet once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt
Time Frame: pre-dose ~ 72 hr of pose-dose
pre-dose ~ 72 hr of pose-dose
Cmax
Time Frame: pre-dose ~ 72 hr of post-dose
pre-dose ~ 72 hr of 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)

November 7, 2025

Primary Completion (Actual)

November 18, 2025

Study Completion (Actual)

December 6, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA2902_BE_I

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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