Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions

This is a Phase 1, randomized, open-label, single-dose, two-period, cross-over study to evaluate the pharmacokinetics (PK) of DW-1021, a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), in healthy adult Vietnamese male volunteers. The study compares DW-1021 with the co-administration of two reference drugs: Pelubi CR 45 mg (Pelubiprofen) and Zytram CR 75 mg (Tramadol HCl), under fasting conditions. A total of 14 eligible participants will be randomly assigned to receive either the test drug followed by the reference drugs, or vice versa, with a 14-day washout period between the two dosing periods. Blood samples will be collected over a 48-hour period after each administration to evaluate drug concentrations. The main purpose is to assess and compare the rate and extent of absorption (Cmax, AUC) of the test and reference products. The study is sponsored by Haiphong University of Medicine and Pharmacy in collaboration with Daewon Pharmaceutical Co., Ltd. It is conducted under ethical approval by the National Ethics Committee in Biomedical Research of Vietnam.

NCT Number	NCT07032558
Lead Sponsor	Haiphong University of Medicine and Pharmacy Collaborators: Daewon Pharmaceutical Co., Ltd., Big Leap Research
Conditions	Healthy Volunteer
Enrollment	14 participants
Start Date	2025-09-20
Primary Completion	2025-09-25 (estimated)
Study Completion	2025-10-25 (estimated)
Updated on ClinicalTrials.gov	2025-08-28