%0 Journal Article %T 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* %A Maria A. Annunziato %A Maria Gonzalez Yibirin %A Inatti Alfredo %A Maria M. Soler %J Open Access Library Journal %V 5 %N 6 %P 1-7 %@ 2333-9721 %D 2018 %I Open Access Library %R 10.4236/oalib.1104366 %X
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 ¡Á 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: Cmax, AUC0-t and AUC0-¡Þ. For the bioequivalence analysis, the AUC0-t was calculated from the time of administration to the 12th 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 Cmax, Tmax, AUC0-t and AUC0-¡Þ. Results: Cmax 8.3529 ¡À 1.9176 ¦Ìg/mL vs. 7.7175 ¡À 2.1751 ¦Ìg/mL, Tmax 0.75 h vs. 1.25 h, AUC0-12 25.9560 ¡À 4.9846 ¦Ìg/mL/hr vs. 24.9015 ¡À 5.1507 ¦Ìg/mL/ hr and AUC0-¡Þ 27.0147 ¡À 5.1099 ¦Ìg/mL/hr vs. 25.6400 ¡À 5.1144 ¦Ìg/mL/h, respectively. 95% IC: Cmax 106.26% - 107.85%, AUC0-12 101.11% - 101.78% and AUC0-¡Þ 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 Cmax were maintained in the range of 80% - 125%.
%K Ketoprofen %K Extended Release %K Tablets %K Bioequivalence %U http://www.oalib.com/paper/5293108