Systemic Exposure

In a pharmacokinetic study in healthy volunteers,
Minimal systemic exposure with FLECTOR Patch1
After 4 days of repeated dosing with FLECTOR Patch, systemic exposure of diclofenac was <1% of the systemic exposure with a single 50-mg oral dose of diclofenac sodium.
The clinical significance of these pharmacokinetic data is unknown.
Data on File, Pfizer Inc. A single-center, open-label, randomized study comparing the systemic bioavailability of FLECTOR Patch at steady state with a marketed 50-mg oral diclofenac sodium tablet after 1 dose in 24 healthy subjects. All 24 subjects applied FLECTOR Patch every 12 hours for 4 days, and serial blood samples were collected up to 48 hours postdose to determine mean steady-state values of maximum, minimum, and average plasma concentrations (Cmax, Cmin, Cavg), and area under the curve (AUC). In a crossover design, 12 subjects received 1 dose of 50-mg oral diclofenac sodium, and serial blood samples were collected up to 12 hours to determine Cmax, Time to Cmax (Tmax), drug elimination half-life (T1/2), and AUCt.
1. Rusca A, Mautone G, Sun S, Magelli M, Johnson F. Comparison of plasma pharmacokinetics of FLECTOR patch (diclofenac epolamine topical patch) and or Voltaren (diclofenac sodium enteric-coated tablets) in healthy volunteers [abstract 279]. J Pain. 2008;9(4 suppl 2):45.