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

Study acronym: DW-1021F
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2025 (before its estimated October 25, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jul 20, 2025 to Sep 20, 2025
    • Study sites: 1 to 2
    • Primary completion date: Jul 25, 2025 to Oct 25, 2025
    • Study completion date: Aug 25, 2025 to Nov 25, 2025
    • Publications: details revised at 2 of 3 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07060209
Lead Sponsor Haiphong University of Medicine and Pharmacy
Collaborators: Daewon Pharmaceutical Co., Ltd., Big Leap Research
Conditions
(from sponsor)		 Healthy Volunteers, Pharmacokinetics, Food Effect in Healthy Volunteers
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov