A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R

March 31, 2026 updated by: Dong-A ST Co., Ltd.

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of DA-5230 With DA-5230-R in Healthy Adult Volunteers

A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of DA-5230 With DA-5230-R in Healthy Adult Volunteers

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

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 participants aged 19 to 55 years at the time of screening visit
  • Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion Criteria:

  • Participants who have received an investigational product in another clinical trial or a bioequivalence study within 6 months prior to the first dosing
  • Participants deemed unsuitable for participation in this clinical trial by the investigator

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
Period 1(DA-5230-R), Period 2(DA-5230)
Drug: DA-5230
Test drug
Drug: DA-5230-R
Reference drug
Experimental: Sequence B
Period 1(DA-5230), Period 2(DA-5230-R)
Drug: DA-5230
Test drug
Drug: DA-5230-R
Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
pre-dose (0hour) to 72hours
Cmax
Time Frame: pre-dose (0hour) to 72hours
Maximum concentration of drug in plasma
pre-dose (0hour) to 72hours

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DA5230_BE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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