DW4421 with three NSAIDs: testing safety and drug interactions in healthy adults
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers
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 |
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 50 Years |
| Sex | All |
| Sponsor | Daewon Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Cheongju-si) |
| Trial ID | NCT07343245 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cheongju-si
- Chungbuk National University Hospital — Cheongju-si, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.