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Clinical trial

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

NCT07060209 is registered in ClinicalTrials.gov with Haiphong University of Medicine and Pharmacy as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Haiphong University of Medicine and Pharmacy
Phase
Phase 1
Overall status
Recruiting
Start date
September 20, 2025
Completion date
November 25, 2025
Enrollment
14 (estimated)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

food effect in healthy volunteers, healthy volunteers, pharmacokinetics