Healthy Adult VolunteersPhase 1NCT07382661
Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin
A Phase 1 study testing DW4421, DW4421-1 and DW4421-2 in people with Healthy Adult Volunteers, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- DW4421, DW4421-1 and DW4421-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
Chungbuk National University Hospital, +82-43-269-6771, cbnuhirb@naver.com
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics Drug-drug Interaction of DW4421 and Amoxicillin/Clarithromycin in Healthy Adult Volunteers
Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin
- Conditions
- Healthy Adult Volunteers
- Being tested
- DW4421, DW4421-1, DW4421-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW4421Drug
1 tablet will be orally administered
DW4421-1Drug
2 capsules will be orally administered
DW4421-2Drug
1 tablet will be orally administered
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | A-B-C (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
| Sequence 2 | Experimental | A-C-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
| Sequence 3 | Experimental | B-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
| Sequence 4 | Experimental | B-C-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
| Sequence 5 | Experimental | C-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
| Sequence 6 | Experimental | C-B-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) Receives: Drug: DW4421; Drug: DW4421-1; Drug: DW4421-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state
Measured: Up to day 6 or day 7
AUCτ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state
Measured: Up to day 6 or day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
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
- NCT07382661
- Sponsor's protocol ID
- DW4421-103
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics Drug-drug Interaction of DW4421 and Amoxicillin/Clarithromycin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07382661
- Acronym / sponsor ID
- DW4421-103
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Feb 2026 (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.
Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2A-B-C (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
| Sequence 2 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2A-C-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
| Sequence 3 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2B-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
| Sequence 4 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2B-C-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
| Sequence 5 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2C-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
| Sequence 6 | Experimental | Drug: DW4421, Drug: DW4421-1, Drug: DW4421-2C-B-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Key exclusion criteria (1 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
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 |
|---|---|---|
| DW44211 tablet will be orally administered | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| DW4421-12 capsules will be orally administered | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| DW4421-21 tablet will be orally administered | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state
Time frame: Up to day 6 or day 7
AUCτ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state
Time frame: Up to day 6 or day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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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.
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 DW4421, DW4421-1 and DW4421-2 in people with Healthy Adult Volunteers, 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 1 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state (time frame: Up to day 6 or day 7). 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 4 Feb 2026.