A Randomized, Open-label Study to Evaluate Food Effects on Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) in Healthy Adult Vietnamese Males

What this Trial Is About

Researchers are evaluating how food intake affects the way the body absorbs and processes DW-1021, a combination tablet containing pelubiprofen and tramadol. This Phase 1, open-label, single-dose crossover study involves healthy adult Vietnamese males and aims to understand the impact of a high-fat meal on drug absorption. The study uses a two-period, two-sequence design where each participant receives the medication both while fasting and after eating. Participants will take one dose of DW-1021 under fasting conditions and another dose under fed conditions, separated by a 14-day washout period to prevent overlap effects. Blood samples will be collected after each dose to measure levels of pelubiprofen, its active metabolite, tramadol, and its metabolite. Safety will be assessed by monitoring adverse events, laboratory tests, vital signs, and ECGs throughout the study. During the study, participants will undergo intensive blood sampling up to 48 hours after each dose to assess maximum plasma concentration and drug exposure over time. Researchers will also evaluate other pharmacokinetic measures such as time to maximum concentration and clearance rates. Safety monitoring includes checking for adverse events and vital signs. The total participation involves two dosing periods with a washout in between, providing detailed information on how food affects DW-1021's pharmacokinetics.

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