Bioequivalence of 150 mg Extended-Release Ketoprofen from Laboratories LETI S.A.V. Test, vs ProfenidBI of Laboratories Sanofi-Aventis Pharmaceuticals LTDA, Prolonged Release, Reference, in Healthy Volunteers*

Objective: To evaluate the bioequivalence between two formulations of ketoprofen after administration of a 150 mg extended release tablet (L.P. Profe-nidBI), 150 mg modified release tablets. Methods: A single-dose cross-over, randomized study was performed under fasting conditions with two treatments, two periods, two sequences (2 2) with a 7-day washout period between each dose in 28 healthy volunteers. Subjects were randomly assigned to each of the administration sequences. The pharmacokinetic parameters evaluated were: C max , AUC 0-t and AUC 0- . For the bioequivalence analysis, the AUC 0-t was calculated from the time of administration to the 12 th hour, posology requested for the medication test, by the trapezoidal method; Software: Excel. The means and Confidence Intervals were compared between 80% -125% for the quotient of C max , T max , AUC 0-t and AUC 0- . Results: C max 8.3529 1.9176 g/mL vs. 7.7175 2.1751 g/mL, T max 0.75 h vs. 1.25 h, AUC 0-12 25.9560 4.9846 g/mL/hr vs. 24.9015 5.1507 g/mL/ hr and AUC 0- 27.0147 5.1099 g/mL/hr vs. 25.6400 5.1144 g/mL/h, respectively. 95% IC: C max 106.26% -107.85%, AUC 0-12 101.11% -101.78% and AUC 0- 100.53% -102.94%. Conclusion: The test formulation Ketoprofen 150 mg LP, manufactured by LETI S.A.V. Laboratories, is bioequivalent with respect to the reference product ProfenidBI 150 mg controlled release tablets, manufactured by Sanofi-Aventis Pharmaceuticals LTDA Laboratories, as the Values obtained from AUC and C max were maintained in the range of 80% -125%.