Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults

This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.

NCT Number	NCT07060209
Lead Sponsor	Haiphong University of Medicine and Pharmacy Collaborators: Daewon Pharmaceutical Co., Ltd., Big Leap Research
Conditions	Healthy Volunteers, Pharmacokinetics, Food Effect in Healthy Volunteers
Enrollment	14 participants
Start Date	2025-09-20
Primary Completion	2025-10-25 (estimated)
Study Completion	2025-11-25 (estimated)
Updated on ClinicalTrials.gov	2025-08-28