Healthy VolunteersPhase 1NCT05954338
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
A Phase 1 study testing DWC202307, DWJ1543 and DWC202216 in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DWC202307, DWJ1543 and DWC202216
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 year old
- Healthy adult volunteer
Who cannot join
- Eye disorders including cataracts
- Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
About this study
Official title: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With Concomitant Multiple Oral Doses of DWC202307 in Healthy Adult Volunteers
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
Read the detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.
- Conditions
- Healthy Volunteers
- Being tested
- DWC202307, DWJ1543, DWC202216
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWC202307Drug
DWC202307
DWJ1543Drug
DWJ1543
DWC202216Drug
DWC202216
| Study group | Role | What they receive |
|---|---|---|
| Intervention: DWC202307 + DWJ1543 | Experimental | Not described Receives: Drug: DWC202307; Drug: DWJ1543 |
| Intervention: DWC202307 + DWC202216 | Experimental | Not described Receives: Drug: DWC202307; Drug: DWC202216 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543
Measured: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
Measured: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954338
- Sponsor's protocol ID
- DW_DWJ1543102
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With Concomitant Multiple Oral Doses of DWC202307 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05954338
- Acronym / sponsor ID
- DW_DWJ1543102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 Jul 2023 (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.
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
Detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: DWC202307 + DWJ1543 | Experimental | Drug: DWC202307, Drug: DWJ1543 |
| Intervention: DWC202307 + DWC202216 | Experimental | Drug: DWC202307, Drug: DWC202216 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 19 year old
- Healthy adult volunteer
Key exclusion criteria (2 listed)
- Eye disorders including cataracts
- Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
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 |
|---|---|---|
| DWC202307DWC202307 | Drug | Intervention: DWC202307 + DWC202216, Intervention: DWC202307 + DWJ1543 |
| DWJ1543DWJ1543 | Drug | Intervention: DWC202307 + DWJ1543 |
| DWC202216DWC202216 | Drug | Intervention: DWC202307 + DWC202216 |
Primary outcome
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543
Time frame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
Time frame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Screening Protocol
Pain
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWC202307, DWJ1543 and DWC202216 in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD..
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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 (time frame: At pre-dose (0 hour), and post-dose 1 to 120 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 24 Jul 2023.