Qilu Pharmaceutical Initiates Pharmacokinetic Study of Aflufibran Patch for Osteoarthritis Pain and Inflammation

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has initiated an absorption pharmacokinetic study evaluating the test formulation of Flurbiprofen Cataplasm compared with the reference formulation, Flurbiprofen Cataplasm (Loqoa Tape), in healthy adult subjects. The clinical trial registration number is CTR20253906, with the initial information disclosure date on September 25, 2025.

The drug formulation is a patch, with a dosage of 40mg/patch × 1 patch, applied to clean, dry, hairless, and unbroken healthy skin on the back. It is administered as a single dose, once per cycle. The purpose of this trial is to study the pharmacokinetics and safety of a single dose of the test formulation compared to the reference formulation in healthy adult subjects under fasting conditions.

Eflornithine Patch is a chemical drug, with indications for pain relief and anti-inflammation in osteoarthritis. Osteoarthritis is a disease caused by the degeneration and wear of articular cartilage, with symptoms including pain, swelling, restricted movement, etc., and diagnosis relies on symptoms, physical signs, and imaging examinations.

The primary endpoint indicators of this trial include Cmax, AUC0-t, AUC0-∞; secondary endpoint indicators include Tmax, t1/2, λz, AUC_%Extrap, CL, Vd, F, and other efficacy indicators, as well as safety indicators such as adverse events, serious adverse events, and adverse reactions.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 12 participants.

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Editor: Xiaolang Express