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

PHASE1RecruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 20, 2025

Primary Completion Date

October 25, 2025

Study Completion Date

November 25, 2025

Conditions
Healthy VolunteersPharmacokineticsFood Effect in Healthy Volunteers
Interventions
DRUG

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.

Trial Locations (2)

180000

RECRUITING

Clinical Trial and Bioequivalence Center, Haiphong

RECRUITING

Clinical Trial and Bioequivalence Center, Haiphong

All Listed Sponsors
collaborator

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

collaborator

Big Leap Research

OTHER

lead

Haiphong University of Medicine and Pharmacy

OTHER

NCT07060209 - Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults | Biotech Hunter | Biotech Hunter