14
Participants
Start Date
September 20, 2025
Primary Completion Date
October 25, 2025
Study Completion Date
November 25, 2025
DW-1021
A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form), administered as a single oral dose under fasting and fed conditions in a two-period, two-sequence crossover design. Each subject receives the intervention once under each condition with a 14-day washout period.
RECRUITING
Clinical Trial and Bioequivalence Center, Haiphong
RECRUITING
Clinical Trial and Bioequivalence Center, Haiphong
Collaborators (2)
Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Big Leap Research
OTHER
Haiphong University of Medicine and Pharmacy
OTHER