DW4421 with three NSAIDs: testing safety and drug interactions in healthy adults
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers
Run by Daewon Pharmaceutical Co., Ltd. · NCT07343245 · Data updated 2026-11-12
This will test whether DW4421 interacts safely with three different NSAIDs in healthy adults aged 19–50.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 50 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Daewon Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Cheongju-si) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | February 22, 2026 |
| Study ends | June 17, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07343245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 19 to 50 years, weighing 50–90 kg with a BMI of 18–27 kg/m2 and without significant liver, kidney, cardiovascular, neurological, respiratory, endocrine, hematologic, oncologic, urinary, or psychiatric disease are ideal candidates.
✕Probably not a fit
People with significant medical conditions, abnormal liver or kidney function, or those outside the specified age, weight, or BMI ranges are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, single-center interventional trial tests safety and drug-drug interactions between the investigational agent DW4421 and three different NSAIDs in healthy adult volunteers. Eligible participants who meet age, weight, and BMI limits and have no significant medical history will receive DW4421 alone and in combination with each NSAID while investigators monitor for adverse events and collect blood samples for pharmacokinetic analysis. The study uses controlled dosing and sequential sampling to detect changes in DW4421 exposure or NSAID exposure when co-administered. Conducted at Chungbuk National University Hospital and sponsored by Daewon Pharmaceutical, the results will inform dosing and safety guidance for future patient studies.
Why it matters
Potential benefit: If successful, the study could identify safe co‑use patterns and dosing guidance that reduce the risk of harmful interactions when DW4421 is given with common NSAIDs.
How similar studies have gone: Drug-drug interaction studies in healthy volunteers are a standard and often successful way to identify interaction risks, though the interaction profile of DW4421 specifically is untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
Where it's running
-
Chungbuk National University Hospital
Cheongju-si, South Korea Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oura Ring validation for sleep using gold-standard sleep tests
This study tests how well the Oura Ring matches the gold-standard sleep test ( PSG ) in healthy adults and people with sleep apnea.
-
Magnetic field maps with NV sensors for non-invasive heart measurements
This study tests whether diamond-based NV magnetometers can non-invasively detect and map the heart's magnetic field in healthy adults.
-
Cognitive Tasks and Models in a Large Online Sample
This study tests cognitive tasks and computational models in a large online group to see if these tools can help predict symptoms like hallucinations and delusions in the general population.
-
Single-dose study of DTI-117 given by injection in healthy adults
Researchers are testing a one-time dose of DTI-117 in healthy adult volunteers to see if it is safe and how it moves through the body.
-
Data-driven rural wellness interventions for vitality and endurance (DRIVE) pilot
This pilot test will see if personalized wellness coaching based on genomic, clinical, behavioral, and functional data can be feasibly delivered in a rural setting and improve cardiometabolic, cognitive, mental health, and functional outcomes over four months.
-
White potato meals and when you eat them: how timing changes blood sugar and appetite
This study tests how eating white potatoes with meals at different times affects blood sugar, hunger, and how much people eat later in healthy adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.