HealthyPhase 1NCT05106205
Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects
A Phase 1 study testing DA-5213 10mg and DA-5213-R 10mg in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-5213 10mg and DA-5213-R 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2021to 20 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- BMI between 18.0 and 30.0 kg/m2
- Body weight : Male≥50kg, Female≥45kg
Who cannot join
- Allergy or Drug hypersensitivity
- Clinically significant Medical History
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- DA-5213 10mg, DA-5213-R 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5213 10mgDrug
single dose administration (one tablet once a day)
DA-5213-R 10mgDrug
single dose administration (one tablet once a day)
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: DA-5213 10mg; Drug: DA-5213-R 10mg |
| Sequence B | Experimental | Not described Receives: Drug: DA-5213 10mg; Drug: DA-5213-R 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
area under the curve
Measured: [Time Frame: pre-dose~48 hours post-dose]
Cmax
maximum plasma concentration
Measured: [Time Frame: pre-dose~48 hours post-dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start21 Dec 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106205
- Sponsor's protocol ID
- BIBE2021-55
- Status last verified
- Jun 2022
- First submitted
- 24 Oct 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05106205
- Acronym / sponsor ID
- BIBE2021-55
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 3 Nov 2021 (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.
Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects
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-5213 10mg, Drug: DA-5213-R 10mg |
| Sequence B | Experimental | Drug: DA-5213 10mg, Drug: DA-5213-R 10mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers
- BMI between 18.0 and 30.0 kg/m2
- Body weight : Male≥50kg, Female≥45kg
Key exclusion criteria (2 listed)
- Allergy or Drug hypersensitivity
- Clinically significant Medical History
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-5213 10mgsingle dose administration (one tablet once a day) | Drug | Sequence A, Sequence B |
| DA-5213-R 10mgsingle dose administration (one tablet once a day) | Drug | Sequence A, Sequence B |
Primary outcome
AUCt
Time frame: [Time Frame: pre-dose~48 hours post-dose]
area under the curve
Cmax
Time frame: [Time Frame: pre-dose~48 hours post-dose]
maximum plasma concentration
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 13 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-5213 10mg and DA-5213-R 10mg in people with Healthy, 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 3 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 13 Jun 2022. 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: [Time Frame: pre-dose~48 hours post-dose]). 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 13 Jun 2022.