Drug Drug InteractionPhase 1NCT06119958
Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects
A Phase 1 study testing DWC202313 and DWC202314 in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- DWC202313 and DWC202314
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 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 to 45 years
- All sexes
- Healthy volunteers accepted
- 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
Seung-Hyun Kang, MD, Ph D., 070-4665-9490, juspa@newyjh.com
About this study
Official title: A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.
- Conditions
- Drug Drug Interaction
- Being tested
- DWC202313, DWC202314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWC202313Drug
Experimental Drug 1
DWC202314Drug
Experimental Drug 2
| Study group | Role | What they receive |
|---|---|---|
| DWC202313 | Experimental | DWC202313 Receives: Drug: DWC202313 |
| DWC202314 | Experimental | DWC202314 Receives: Drug: DWC202314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of DWC202313 and DWC202314
Measured: Up to 14 days
AUCt,ss of DWC202313 and DWC202314
Measured: Up to 14 days
Secondary outcomes (6)
Tmax,ss of DWC202313 and DWC202314
Measured: Up to 14 days
Cmin,ss of DWC202313 and DWC202314
Measured: Up to 14 days
t1/2 of DWC202313 and DWC202314
Measured: Up to 14 days
CLss/F of DWC202313 and DWC202314
Measured: Up to 14 days
Vdss/F of DWC202313 and DWC202314
Measured: Up to 14 days
PTF of DWC202313 and DWC202314
Measured: Up to 14 days
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 start27 Oct 2023
- 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 Drug Drug InteractionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT06119958
- Sponsor's protocol ID
- DWJ1622101
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06119958
- Acronym / sponsor ID
- DWJ1622101
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- 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 is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWC202313 | Experimental | Drug: DWC202313DWC202313 |
| DWC202314 | Experimental | Drug: DWC202314DWC202314 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| DWC202313Experimental Drug 1 | Drug | DWC202313 |
| DWC202314Experimental Drug 2 | Drug | DWC202314 |
Primary outcome
Cmax,ss of DWC202313 and DWC202314
Time frame: Up to 14 days
AUCt,ss of DWC202313 and DWC202314
Time frame: Up to 14 days
6 secondary outcomes
Tmax,ss of DWC202313 and DWC202314
Time frame: Up to 14 days
Cmin,ss of DWC202313 and DWC202314
Time frame: Up to 14 days
t1/2 of DWC202313 and DWC202314
Time frame: Up to 14 days
CLss/F of DWC202313 and DWC202314
Time frame: Up to 14 days
Vdss/F of DWC202313 and DWC202314
Time frame: Up to 14 days
PTF of DWC202313 and DWC202314
Time frame: Up to 14 days
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.
Related trials for Drug Drug Interaction
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
Not yet recruitingPhase 1
Effect of Itraconazole on the Pharmacokinetics of Intravenous HRS-4642 in Healthy Participants
Drug Interactions
RecruitingObservational study
Developing a Methodological Framework and a Dissemination Plan for Herb-drug Interactions-related Clinical Practice Guidelines
Herb-drug Interactions
RecruitingPhase 1
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Drug-drug Interaction
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 DWC202313 and DWC202314 in people with Drug Drug Interaction, 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 Seung-Hyun Kang, MD, Ph D (070-4665-9490, juspa@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 DWC202313 and DWC202314 (time frame: Up to 14 days). 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.