Study Summary: Systemic bioavailability of topical diclofenac sodium gel 1%

Study Objective & Methodology

A seven-week, single-center, randomized, open-label, multiple-dose, 3-way crossover study conducted in healthy volunteers ≥ 50 years (n=40) to compare the systemic bioavailability and pharmacodynamics of topical diclofenac sodium gel 1% vs. oral diclofenac sodium 50-mg tablets.

Results

• Systemic exposure and maximum plasma concentrations of diclofenac were significantly lower with diclofenac gel 1% than with oral diclofenac sodium
• Platelet aggregation and COX-1 were minimally inhibited by DSG when compared with DS Tab which ensures low risk of cardiovascular health related AEs
• Topical diclofenac, with a more favorable safety profile, represents a useful alternative to oral diclofenac therapy in pain management

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