Healthy VolunteersPhase 1NCT06119945
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers
A Phase 1 study testing DWJ1568 and DWC202215 in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy 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?
- DWJ1568 and DWC202215
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2023to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 19 year old
Who cannot join
- Galactose intolerance
- Lapp lactase deficiency
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
H Plus YANGJI Hospital
Seoul
MunJeong Bae, MD, Ph D., 070-4665-9174, m4222@newyjh.com
About this study
Official title: An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers
Read the detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.
- Conditions
- Healthy Volunteers
- Being tested
- DWJ1568, DWC202215
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1568Drug
One tablet of DWJ1568
DWC202215Drug
One tablet of DWC202215
| Study group | Role | What they receive |
|---|---|---|
| DWJ1568 | Experimental | DWJ1568 Receives: Drug: DWJ1568 |
| DWC202215 | Active comparator | DWC202215 Receives: Drug: DWC202215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Secondary outcomes (4)
AUCinf of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Tmax of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt/AUCinf of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 to 72 hour.
t1/2 of DWJ1568 and DWC202215
Measured: At pre-dose (0 hour), and post-dose 0 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 posted7 Nov 2023
- Study start9 Nov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 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
- 44 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
- NCT06119945
- Sponsor's protocol ID
- DWJ1568101
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 7 Nov 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06119945
- Acronym / sponsor ID
- DWJ1568101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Nov 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 compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers
Detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1568 | Experimental | Drug: DWJ1568DWJ1568 |
| DWC202215 | Active comparator | Drug: DWC202215DWC202215 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 19 year old
Key exclusion criteria (2 listed)
- Galactose intolerance
- Lapp lactase deficiency
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 |
|---|---|---|
| DWJ1568One tablet of DWJ1568 | Drug | DWJ1568 |
| DWC202215One tablet of DWC202215 | Drug | DWC202215 |
Primary outcome
Cmax,ss of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
4 secondary outcomes
AUCinf of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Tmax of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt/AUCinf of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
t1/2 of DWJ1568 and DWC202215
Time frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
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 DWJ1568 and DWC202215 in people with Healthy Volunteers, run by Daewoong 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 1 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 7 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MunJung Bae, MD, Ph D (070-4665-9174, m4222@newyjh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss of DWJ1568 and DWC202215 (time frame: At pre-dose (0 hour), and post-dose 0 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 7 Nov 2023.