Recruiting PHASE1 INTERVENTIONAL 2-arm NCT07060209

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

A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg / Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions

Sponsor: Big Leap Research

Conditions Food Effect in Healthy Volunteers Healthy Volunteers Pharmacokinetics

Interventions DW-1021

Updated 2 times since 2025 Last updated: Aug 22, 2025 Started: Sep 20, 2025 Primary completion: Oct 25, 2025 Completion: Nov 25, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Food Effect in Healthy Volunteers and Healthy Volunteers and is currently actively recruiting participants. Big Leap Research leads this study, which shows 2 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

2 versions recorded

Sep 2025 — Present [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Aug 2025 — Sep 2025 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Big Leap Research
Daewon Pharmaceutical Co., Ltd.
Haiphong University of Medicine and Pharmacy

Data source: Haiphong University of Medicine and Pharmacy

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Haiphong, Vietnam