Bioavailability of diclofenac potassium at low doses

摘要: Aim Diclofenac-K has been recently launched at low oral doses in different countries for over-the-counter use. However, given the considerable first-pass metabolism of diclofenac, degree absorption diclofenac-K remained to be determined. The aim this study was determine bioavailability low-dose diclofenac-K. Methods A randomized, three-way, cross-over performed 10 subjects. Each received diclofenac-K, 22.5 mg via short-term i.v. infusion and orally single 12.5 mg 25 mg. Results Mean (± SD) times maximal plasma concentration (tmax) diclofenac were 0.48 ± 0.28 h (12.5 mg) 0.93 ± 0.96 h (25 mg). absolute after administration did not differ significantly 12.5-mg 25-mg dose group (63.1 ± 12.6%vs. 65.1 ± 19.4%, respectively). 90% confidence intervals AUC∞ AUCt ratios two regimes 82.6, 103.4% (point estimate 92.4%) 86.2, 112.9% 98.6%), respectively. These values within acceptance criteria bioequivalence (80–125%). Conclusions Our data indicate that is rapidly well absorbed dose, are consistent with a rapid onset action drug. Abbreviations AUC, area under concentraton-time curve; Cmax, peak concentration; CI, interval; COX, cyclooxygenase; D, dose; F, bioavailability; tmax, time reach Cmax.