What is DW4421 studying for healthy adults?

DW4421 is being studied to understand its safety and how it interacts with three different NSAIDs in healthy adults. This research is important to see how these drugs affect each other when taken together. The study is sponsored by Daewon Pharmaceutical Co., Ltd. and focuses on healthy volunteers aged 19 to 50.

Who may be eligible for this healthy adult clinical trial?

Adults between 19 and 50 years old who are healthy and weigh between 50 kg and 90 kg with a BMI between 18 and 27 kg/m2 may be eligible. Participants must not have significant diseases affecting organs like liver, kidney, heart, or mental health. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 19Years - 50Years

All Genders

Healthy Volunteers

ID07343245

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers

Led by Daewon Pharmaceutical Co., Ltd. · Updated on 2026-01-15

150

Participants Needed

Research Sites

16 weeks

Total Duration

AI-Summary

What this Trial Is About

This trial investigates the safety and drug-drug interaction between DW4421 and three different nonsteroidal anti-inflammatory drugs NSAIDs in healthy adult volunteers. The study is a Phase 1 clinical trial designed to assess how these drugs interact in the body, focusing on their pharmacokinetics, which helps understand the drug levels and behavior over time. Participants will receive different forms of the investigational drug DW4421, administered once daily or twice daily depending on the variant DW4421, DW4421-N1, DW4421-N2, DW4421-N3. The study is randomized and includes several cohorts to evaluate these combinations carefully. Each participant will follow specific dosing schedules during the trial. During the trial, researchers will monitor participants closely through various assessments including measuring drug concentration peaks Cmax and overall exposure AUC from baseline to study days 13 or 15. Healthy volunteers aged 19 to 50 will be observed for any safety concerns or changes in how the drugs work together. The total study participation lasts from the start until the final assessments around day 15, with continuous monitoring of drug interactions and safety.

CONDITIONS

Brief Title

A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs

Who Can Participate

Age: 19Years - 50Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy adult aged 19 to 50 (inclusive) years at the time of screening
Weight between 50 kg and 90 kg
Body mass index (BMI) between 18 and 27 kg/m2 (inclusive) at screening visit

You will not qualify if you...

History or presence of clinically significant diseases affecting liver, kidney, nervous system, respiratory, endocrine, blood, cancer, cardiovascular, urinary, or mental health

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