%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