Healthy Adult ParticipantsPhase 1NCT07513649
A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R
A Phase 1 study testing DA-5230 and DA-5230-R in people with Healthy Adult Participants, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- DA-5230 and DA-5230-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2026to 28 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Healthy Adult Participants
- Being tested
- DA-5230, DA-5230-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5230Drug
Test drug
DA-5230-RDrug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1(DA-5230-R), Period 2(DA-5230) Receives: Drug: DA-5230; Drug: DA-5230-R |
| Sequence B | Experimental | Period 1(DA-5230), Period 2(DA-5230-R) Receives: Drug: DA-5230; Drug: DA-5230-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the plasma concentration-time curve during dosing interval (AUCt)
Measured: pre-dose (0hour) to 72hours
Cmax
Maximum concentration of drug in plasma
Measured: pre-dose (0hour) to 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start4 May 2026
- Primary completion4 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHyun Kang, M.D., Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513649
- Sponsor's protocol ID
- DA5230_BE
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07513649
- Acronym / sponsor ID
- DA5230_BE
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DA-5230, Drug: DA-5230-RPeriod 1(DA-5230-R), Period 2(DA-5230) |
| Sequence B | Experimental | Drug: DA-5230, Drug: DA-5230-RPeriod 1(DA-5230), Period 2(DA-5230-R) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-5230Test drug | Drug | Sequence A, Sequence B |
| DA-5230-RReference drug | Drug | Sequence A, Sequence B |
Primary outcome
AUCt
Time frame: pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
Cmax
Time frame: pre-dose (0hour) to 72hours
Maximum concentration of drug in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SeungHyun Kang, M.D. principal investigator
H Plus Yangji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-5230 and DA-5230-R in people with Healthy Adult Participants, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (time frame: pre-dose (0hour) to 72hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.