Clinical Trial: A Randomized Crossover Study Comparing DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions

U.S., June 25 -- ClinicalTrials.gov registry received information related to the study (NCT07032558) titled 'A Randomized Crossover Study Comparing DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions' on June 15.

Brief Summary: This is a Phase 1, randomized, open-label, single-dose, two-period, cross-over study to evaluate the pharmacokinetics (PK) of DW-1021, a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), in healthy adult Vietnamese male volunteers. The study compares DW-1021 with the co-administration of two reference drugs: Pelubi CR 45 mg (Pelubiprofen) and Zytram CR 75 mg (Tramadol HCl), under fasting conditions.

A total of 14 eligible participants will be ra...