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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*

DOI: 10.4236/oalib.1104366, PP. 1-7

Subject Areas: Pharmacology, Clinical Trials, Rheumatology

Keywords: Ketoprofen, Extended Release, Tablets, Bioequivalence

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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: Cmax, AUC0-t and AUC0-∞. 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-∞. Results: Cmax 8.3529 ± 1.9176 μg/mL vs. 7.7175 ± 2.1751 μg/mL, Tmax 0.75 h vs. 1.25 h, AUC0-12 25.9560 ± 4.9846 μg/mL/hr vs. 24.9015 ± 5.1507 μg/mL/ hr and AUC0-∞ 27.0147 ± 5.1099 μg/mL/hr vs. 25.6400 ± 5.1144 μg/mL/h, respectively. 95% IC: Cmax 106.26% - 107.85%, AUC0-12 101.11% - 101.78% and AUC0-∞ 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%.

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Annunziato, M. A. , Yibirin, M. G. , Alfredo, I. and Soler, M. M. (2018). 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*. Open Access Library Journal, 5, e4366. doi:


[1]  Goodman and Gilman (2007) Las bases farmacológicas de la Terapéutica. 11a edición. McGraw-Hill Interamericana.
[2]  Roda, A., et al. (2002) Bioavailability of a New Ketoprofen Formulation for Once-Daily Oral Administration. International Journal of Pharmaceutics, 241, 165-172.
[3]  Ren?ber, S., Karavana, S. and ?zyazici, M. (2009) Bioavailability File: Ketoprofen. Journal of Pharmaceutical Sciences, 34, 203-216.
[4]  Bryson, P.D. (1996) IX Agents for pain: Nonsteroidal Anti-Inflammatory Agents. Characteristics of the NSAIDs. In: Bryson, P.D., Ed., Comprehensive Review in Toxicology for Emergency Clinicians, 3rd Edition, Taylor & Francis, Washington DC, 571.
[5]  Hauschke, D., Steinijans, V.W., Diletti, E. and Burke, M. (1992) Sample Size Determination for Bioequivalence Assessment Using a Multiplicative Model. Journal of Pharmacokinetics and Biopharmaceutics, 20, 557-561.
[6]  Houghton, G.W., et al. (1984) Comparative Pharmacokinetics of Ketoprofen Derived from Single Oral Doses of Ketoprofen Capsules or a Novel Sustainedreleasepellet Formulation. Biopharmaceutics & Drug Disposition, 5, 203-209.
[7]  Shohin, I.E., et al. (2012) Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Ketoprofen. Journal of Pharmaceutical Sciences, 101.
[8]  Delbarre, F., et al. (1976) Pharmacokinetic Study of Ketoprofen (19.583 R.P.) in Man Using Thetritiated Compound. Scandinavian Journal of Rheumatology. Supplement, 45-52.
[9]  Greene, W.L., Concato, J. and Feinstein, A.R. (2000) Claims of Equivalence in Medical Research: Are They Supported by the Evidence? Annals of Internal Medicine, 132, 715-722.
[10]  Song, F., Altman, D., Glenny, A. and Deeks, J. (2003) Validity of Indirect Comparison for Estimating Efficacy of Competing Interventions: Empirical Evidence from Published Meta-Analyses. BMJ, 326, 472.
[11]  Laguna-Goya, N., Blázquez-Pérez, A. and Pozo-Hernández, C. (2006) Legislación sobre autorización de genéricos. Farmacia Hospitalaria, 30, 379-384.


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