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*

Abstract

Objective: To evaluate the bioequivalence between two formulations of ketoprofen after administration of a 150 mg extended release tablet (L.P. ProfenidBI®), 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 μg/mL vs. 7.7175 ± 2.1751 μg/mL, T max 0.75 h vs. 1.25 h, AUC 0-12 25.9560 ± 4.9846 μg/mL/hr vs. 24.9015 ± 5.1507 μg/mL/ hr and AUC 0-∞ 27.0147 ± 5.1099 μg/mL/hr vs. 25.6400 ± 5.1144 μg/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%.