Pelubi CR (pelubiprofen controlled release) / Daewon Pharma - LARVOL DELTA

Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "The relative bioavailability study employed a randomized, single-dose, two-period, two-sequence crossover design (n = 14) comparing DW-1021 with co-administration of Pelubi CR (pelubiprofen 45 mg) and Zytram CR (tramadol hydrochloride 75 mg, equivalent to 65.9 mg tramadol base) under fasting conditions. In conclusion, DW-1021 exhibited analyte-dependent pharmacokinetic differences relative to the reference treatment. Food intake primarily reduced pelubiprofen exposure, while tramadol AUC0-t was minimally affected, with a modest increase in Cmax under fed conditions."

Clinical • Journal • PK/PD data

Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Haiphong University of Medicine and Pharmacy | Not yet recruiting ➔ Recruiting

Enrollment open

Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Haiphong University of Medicine and Pharmacy

New P1 trial

Daewon Pharm wins $3 million deal to export Pelubi to Indonesia (Korea Biomedical Review) - "Daewon Pharmaceutical said Monday the company has signed a contract with PT Interbat, an Indonesian pharmaceutical company, for the exclusive export and supply of finished products of non-steroidal anti-inflammatory drugs (NSAIDs), Pelubi SR Tab (pelubiprofen). The contract's total value is $3 million, and the contract period is five years....Daewon said it has new export contracts with the Philippines and Mexico and is awaiting the completion of product registration in Vietnam. In addition, the company plans to speed up its overseas expansion, focusing on Eurasian Economic Union (EAEU) countries, including Russia and Kazakhstan, Central and South America, and Southeast Asia."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Osteoarthritis • Pain

Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial. (PubMed, PLoS One) - "Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis."

Clinical • Head-to-Head • Journal • P4 data • Immunology • Osteoarthritis • Pain • Rheumatology