OsteoarthritisPhase 1NCT05214690
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2
A Phase 1 study testing DW1809-T2 and DW1809-1 in people with Osteoarthritis and Rheumatoid Arthritis, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Back Pain
- What is being tested?
- DW1809-T2 and DW1809-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2020to 8 Sep 2020
- 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 who are ≥19 years old
- Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Who cannot join
- Clinically significant Medical History
- In the case of women, pregnant(Urine-HCG positive) or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study
- Being tested
- DW1809-T2, DW1809-1
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1809-T2Drug
Also called Test
pelubiprofen 25mg
DW1809-1Drug
Also called Reference
pelubiprofen 30mg (PELUBI tab.)
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | cross-over Receives: Drug: DW1809-T2; Drug: DW1809-1 |
| Sequence B | Experimental | cross-over Receives: Drug: DW1809-T2; Drug: DW1809-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Pharmacokinetics of Pelubiprofen
Measured: up to 8 hour
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of Pelubiprofen
Measured: up to 8 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start13 Aug 2020
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214690
- Sponsor's protocol ID
- DW1809-102
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2021
- Last updated
- 31 Jan 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05214690
- Acronym / sponsor ID
- DW1809-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 31 Jan 2022 (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.
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study
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: DW1809-T2, Drug: DW1809-1cross-over |
| Sequence B | Experimental | Drug: DW1809-T2, Drug: DW1809-1cross-over |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Volunteers who are ≥19 years old
- Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Key exclusion criteria (2 listed)
- Clinically significant Medical History
- In the case of women, pregnant(Urine-HCG positive) or lactating women
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 |
|---|---|---|
| DW1809-T2Also: Testpelubiprofen 25mg | Drug | Sequence A, Sequence B |
| DW1809-1Also: Referencepelubiprofen 30mg (PELUBI tab.) | Drug | Sequence A, Sequence B |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: up to 8 hour
Pharmacokinetics of Pelubiprofen
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 8 hour
Pharmacokinetics of Pelubiprofen
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 31 Jan 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 DW1809-T2 and DW1809-1 in people with Osteoarthritis and Rheumatoid Arthritis, run by Daewon Pharmaceutical 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 31 Jan 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?
Peak Plasma Concentration (Cmax) (time frame: up to 8 hour). 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 31 Jan 2022.