Healthy VolunteersPhase 1NCT06592495
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
A Phase 1 study testing Period 1, Period 2 and Period 3 in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Period 1, Period 2 and Period 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- 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
- Over 19 year old
- Healthy adult volunteers
Who cannot join
- with a history of mental disorder
- For female volunteers, those who are suspected of being pregnant or lactating
Trial locations and contacts
No sites are listed yet.
SHIN, CPL contact
About this study
Official title: Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
Read the detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
- Conditions
- Healthy Volunteers
- Being tested
- Period 1, Period 2, Period 3, Period 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1Drug
DWJ1589 or DWC202315
Period 2Drug
DWJ1589 or DWC202315
Period 3Drug
DWJ1589 or DWC202315
Period 4Drug
DWJ1589 or DWC202315
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: RTRT | Experimental | T: DWJ1589 R: DWC202315 Receives: Drug: Period 1; Drug: Period 2; Drug: Period 3; Drug: Period 4 |
| Sequence B: TRTR | Experimental | T: DWJ1589 R: DWC202315 Receives: Drug: Period 1; Drug: Period 2; Drug: Period 3; Drug: Period 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
Cmax of DWJ1589 and DWC202315
Measured: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
The Area under the curve(AUC)last of DWJ1589 and DWC202315
AUClast of DWJ1589 and DWC202315
Measured: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (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
- Investigators
- KANG, MD, PhD, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592495
- Sponsor's protocol ID
- DW_DWJ1589101
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06592495
- Acronym / sponsor ID
- DW_DWJ1589101
- 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
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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 pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
Detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: RTRT | Experimental | Drug: Period 1, Drug: Period 2, Drug: Period 3, Drug: Period 4T: DWJ1589 R: DWC202315 |
| Sequence B: TRTR | Experimental | Drug: Period 1, Drug: Period 2, Drug: Period 3, Drug: Period 4T: DWJ1589 R: DWC202315 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 19 year old
- Healthy adult volunteers
Key exclusion criteria (2 listed)
- with a history of mental disorder
- For female volunteers, those who are suspected of being pregnant or lactating
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 |
|---|---|---|
| Period 1DWJ1589 or DWC202315 | Drug | Sequence A: RTRT, Sequence B: TRTR |
| Period 2DWJ1589 or DWC202315 | Drug | Sequence A: RTRT, Sequence B: TRTR |
| Period 3DWJ1589 or DWC202315 | Drug | Sequence A: RTRT, Sequence B: TRTR |
| Period 4DWJ1589 or DWC202315 | Drug | Sequence A: RTRT, Sequence B: TRTR |
Primary outcome
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
Time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
Cmax of DWJ1589 and DWC202315
The Area under the curve(AUC)last of DWJ1589 and DWC202315
Time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
AUClast of DWJ1589 and DWC202315
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
SHIN, CPL contact
KANG, MD, PhD principal investigator
H Plus Yangji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Period 1, Period 2 and Period 3 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 23 Sep 2024. 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?
Contact SHIN, CPL (02-550-8858), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315 (time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 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 23 Sep 2024.