Full-text resources of PSJD and other databases are now available in the new Library of Science.
Visit https://bibliotekanauki.pl


Preferences help
enabled [disable] Abstract
Number of results
2014 | 71 | 5 | 843-854

Article title


Title variants

Languages of publication



The aim of the study was to investigate the bioavailability of a generic product of 100 mg and 400 mg imatinib film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence. The secondary objective of the study was to evaluate tolerability of both products. An open-label, randomized, crossover, two-period, single-dose, comparative study was conducted in 43 (Imatynib-Biofarm 100 mg film-coated tablet) and in 42 (Imatynib-Biofarm 400 mg film-coated tablet), brand name Imatenil, Caucasian healthy volunteers in fed conditions. A single oral dose administration of the test or reference product was separated by 14-day washout period. The imatinib and its metabolite N-desmethyl imatinib concentrations were determined using a validated LC MS/MS method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Imatynib-Biofarm 100 mg and 400 mg film-coated tablets manufactured by Biofarm Sp. z o.o. (test products) are bioequivalent to those of Glivec 100 mg and 400 mg film-coated tablets manufactured by Novartis Pharma GmbH (reference products). Both products in the two doses of imatinib were well tolerated.








Physical description




  • 1. Druker B.J., Tamura S., Buchdunger E., Ohno S., Segal G.M., Fanning S., Zimmermann J., Lydon N.B.: Nat. Med. 2, 561 (1996).
  • 2. Druker B.J., Talpaz M., Resta D.J., Peng B., Buchdunger E., Ford J.M., Lydon N.B. et al.: N. Engl. J. Med. 344, 1031 (2001).
  • 3. Buchdunger E., O'Reilly T., Wood J.: Eur. J.Cancer. 38, Suppl. 5, S28 (2002).
  • 4. Druker B.J, Lydon N.B.: J. Clin. Invest. 105, 3 (2000).
  • 5. Buchdunger E., Cioffi C.L., Law N., Stover D., Ohno-Jones S., Druker B.J., Lydon N.B.: J. Pharmacol. Exp. Ther. 295, 139 (2000).
  • 6. Mughal T.I., Goldman J.M.: Eur. J. Cancer 37, 561 (2000).
  • 7. O'Brien S.G., Guilhot F., Larson R.A., Gathmann I., Baccarani M., Cervantes F., Cornelissen J.J. et al.: N. Engl. J. Med. 348, 994 (2003).
  • 8. Hughes T.P., Kaeda J., Branford S., Rudzki Z., Hochhaus A., Hensley M.L., Gathmann I. et al.: N. Engl. J. Med. 349, 1423 (2003).
  • 9. Druker B.J., Guilhot F., O'Brien S.G., Gathmann I., Kantarjian H., Gattermann N., Deininger M.W. et al.: N. Engl. J. Med. 355, 2408 (2006).
  • 10. Lee H.J., Thompson J.E., Wang E.S., Wetzler M.: Cancer 117, 1583 (2011).
  • 11. Mechtersheimer G., Egerer G., Hensel M., Rieker R.J., Libicher M., Lehnert T., Penzel R.: Virchows Arch. 444, 108 (2004).
  • 12. Chabner B.A., Amrein P.C., Druker B.J., Michaelson M.D., Mitsiades C.S., Goss P.E., Ryan D.P. et al.: Chapter 62. Antineoplastic agents. in Goodman & Gilmanís The Pharmacological Basis of Therapeutics, 12th edn., McGraw-Hill, New York 2011.
  • 13. Mac K., Wójcik M.: Postepy Hig. Med. Dosw. 62, 272 (2008).
  • 14. Prenen H., Dumez H., Stefan C., Hoeben A., Wouters C., Van Lierde M.A., Sciot R. et al.: Acta Gastroenterol. Belg. 69, 367 (2006).
  • 15. Nishida T., Shirao K., Sawaki A., Koseki M., Okamura T., Ohtsu A., Sugiyama T. et al.: Int. J. Clin. Oncol. 13, 244 (2008).
  • 16. Chen P., Zong L., Zhao W., Shi L.: World J. Gastroenterol. 16, 4227 (2010).
  • 17. Gronchi A., Blay J.Y., Trent J.C.: Cancer116(8), 1847 (2010).
  • 18. Klion A.D., Robyn J., Maric I., Fu W., Schmid L., Lemery S., Noel P. et al.: Blood110, 3552 (2007).
  • 19. Wang L.N., Pan Q., Fu J.F., Shi J.Y., Jin J., Li J.M., Hu J. et al.: Chin. Med. J. (Engl) 121, 867 (2008).
  • 20. Intermesoli T., Delaini F., Acerboni S., Salmoiraghi S., Spinelli O., Guerini V., Vannucchi A.M. et al.: Br. J. Haematol. 147, 681 (2009).
  • 21. Zhang Y., Qin T.J., Zhou C.L., Liu L., Xiao Z.J.: Zhonghua Xue Ye Xue Za Zhi 30, 381 (2009).
  • 22. Peng B., Lloyd P., Schran H.: Clin. Pharmacokinet. 44, 879 (2005).
  • 23. Gschwind H.P., Pfaar U., Waldmeier F., Zollinger M., Sayer C., Zbinden P., Hayes M. et al.: Drug Metab. Dispos. 33, 1503 (2005).
  • 24. Peng B., Dutreix C., Mehring G., Hayes M.J., Ben-Am M., Seiberling M., Pokorny R. et al.: J. Clin. Pharmacol. 44, 158 (2004).
  • 25. Fitos I., Visy J., Zsila F., Mady G., Simonyi M.: Biochim. Biophys. Acta. 1760, 1704 (2006).
  • 26. Cross S.A., Lyseng-Williamson K.A.: Drugs67, 2645 (2007).
  • 27. Gleevec - Rx List. The Internet Drug Index [data- base on the Internet]. WebMD, Inc. [last revised May2011; cited: 2013 April 26]. Available from: http:// www. rxlist.com/gleevec -drug. htm
  • 28. The European Agency for the Evaluation of Medicinal Products, Note for Guidance on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/1401/98, London, 26 July 2001.
  • 29. The European Medicines Agency, Guidance on the Investigation of Bioequivalence CPMP/ EWP/QWP/1401/98 Rev.1, London, 20 January 2010.
  • 30. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assambly, Helsinki June 1964 and amended by the 59th WMA General Assambly Seoul, Korea 2008.
  • 31. European Agency for Evaluation of Medicinal Products, International Conference on Harmo- nization, in World Health Organization. Guideline for Good Clinical Practice, ICH topic E6. Geneva2002.
  • 32. FDA Guidance for Industry. Statistical approaches to establishing bioequivalence. U.S. Food and Drug Administration, Rockville, MD2001.
  • 33. Schuirmann D.J.: J. Pharmacokinet. Biopharm. 15, 657 (1987).
  • 34. Nikolova Z., Peng B., Hubert M., Seiberling M., Keller U., Ho Y.-Y., Schran H., Capdeville R.: Cancer Chemother. Pharmacol. 53, 433 (2004).
  • 35. Wilkinson G.R.: J. Pharmacokinet. Biopharm. 24, 475 (1996).
  • 36. Grillo D., Polla G., VegaD.: J. Pharm. Sci. 101, 541 (2012).
  • 37. Guidance for Industry. ANDAs: Pharmaceu- tical Solid Polymorphism. Chemistry, Manu- facturing, and Controls Information. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 2007, OGD, http://www.fda.gov/cder/guidance/index. htm
  • 38. Szczepek W., Samson-Lazinska D., Zagrodzki B., Glice M., Maruszak W., Korczak K., Mo- dzelewski R. et al.: ìCrystalline methanesulfon- ic acid addition salts of imatinibî, WO2005/095379 A2 (2005).
  • 39. Zimmermann J. et al.: Polish patent 188348 B1 (1998).

Document Type


Publication order reference


YADDA identifier

JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.