+ Translate

Bioequivalence study of 400 and 100 mg imatinib film-coated tablets in healthy volunteers

, : Bioequivalence study of 400 and 100 mg imatinib film-coated tablets in healthy volunteers. Acta Poloniae Pharmaceutica 71(5): 843-854

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.

(PDF 0-2 workdays service)

Order PDF Full Text


Click here to order any other PDF Full Text

Accession: 051805357

PMID: 25362813

PDF Full Text: Submit

Submit PDF Full Text

No spam - Every submission is manually reviewed

Due to poor quality, we do not accept files from Researchgate

Submitted PDF Full Texts will always be free for everyone
(We only charge for PDFs that we need to acquire)

Select a PDF file:

Other references

Ke, Shuizhou; Zhang, Ming; Shi, Zhou; Zhang, Tong; Fang, Herbert, H. P., 2008: Phenol degradation and microbial characteristics in upflow anaerobic sludge blanket reactors at ambient and mesoplhilic temperatures. A synthetic wastewater containing phenol as sole substrate was respectively treated at temperatures of 26 +/- 1 degrees C and 37 +/- 1 degrees C in 2.8 litre upflow anaerobic sludge blanket (UASB) reactors. At the two temperatures, pH 7.0-7.5, wit...

Westrop, Gareth, D.; Hormozi, E. Kalantar; Da-Costa, Nuno, A.; Parton, Roger; Coote, John, G., 1996: Bordetella pertussis adenylate cyclase toxin: ProCyaA and CyaC proteins synthesised separately in Escherichia coli produce active toxin in vitro. Bordetella pertussis produces a cell-invasive adenylate cyclase toxin (CyaA) which is related to the RTX family of pore-forming toxins. Like all RTX toxins, CyaA is synthesized as a protoxin (proCyaA), encoded by the cyaA gene. Activation to the m...

Michel, E.; Liu, H.; Remley, K.B.; Martin, A.J.; Madison, M.T.; Kucharczyk, J.; Truwit, C.L., 2001: Perfusion MR neuroimaging in patients undergoing balloon test occlusion of the internal carotid artery. BACKGROUND AND PURPOSE: We sought to investigate whether the combination of conventional, diffusion-weighted, and perfusion-weighted MR imaging increases the diagnostic accuracy of balloon test occlusion of the internal carotid artery. We describe...

Radvan, R.; Mĕrka, V., 1972: Effect of performic, peracetic and perpropionic acids on the eggs of Ascaris suum in vitro. Sbornik Vedeckych Praci Lekarske Fakulty Karlovy Univerzity V Hradci Kralove. Supplementum 15(5): 485-490

Mebrahtu Y.; Beach R.; Hendricks L.D.; Khamala C.P.M., 1986: Occurrence of simulium damnosum diptera simuliidae in nine river systems in kenya. Journal of Medical Entomology 23(1): 110-111

Anonymous, 1986: Danish Council of Nurses' legislation. Sygeplejersken 86(36): Suppl 1-19

Bril, A.; Canet, E., 2008: The Innovative Medicine Initiative (IMI). The Innovative Medicine Initiative (IMI) is a joint technology initiative jointly implemented by the European Commission and by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The objective of IMI, officially launche...

Sokolov, V. E.; Ushakova, N. A.; Chernova, O. F., 1993: Interaction between bacteria and the surface of the cutaneous-hair cover in mammals. There is a certain equilibrium between the organism and the bacteria on the surface of the animal's skin, which depends on the structure and physicochemical properties of the external cover. The structure of cuticular scale of the rabbit hair...

Nuttli Otto W., 1986: The current and projected state-of-knowledge on earthquake hazards. Open File Report U: ological Survey. Pages 72-90. 1986.

Casas De Puig C., 1974: Data on the bryophyte flora of spain some mosses and hepatics from the southeastern of spain. Univ Lisboa Fac Cienc Revista Faculdade De Ciencias: 2a Serie C Ciencias Naturais Vol Xvii; Fasc 20 (Review Of The Faculty Of Sciences: Series 2, C Natural Sciences Vol 17, No 2 ) Xxv+800p Illus Biblioteca Da Faculdade De Ciencias: Lisboa, Portugal 603-616, 1973