EurekaMag.com logo
+ Site Statistics
References:
52,725,316
Abstracts:
28,411,598
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on Google+Follow on Google+
Follow on LinkedInFollow on LinkedIn

+ Translate

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


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


Accession: 051805357

PMID: 25362813



Related references

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers. Kardiologia Polska (): -, 2016

Bioequivalence study of 8 mg ondansetron film-coated tablets in healthy Caucasian volunteers. Drug Research 64(4): 220-224, 2014

Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers. Acta Poloniae Pharmaceutica 69(6): 1356-1363, 2013

Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clinical Therapeutics 31(10): 2224-2232, 2010

Bioequivalence studies for two different strengths of montelukast in healthy volunteers: 10 mg film-coated tablets and 5 mg chewable tablets. Drug Research 63(9): 477-483, 2013

Bioequivalence study of two formulations of ibandronic acid 150-mg film-coated tablets in healthy volunteers under fasting conditions: a randomized, open-label, three-way, reference-replicated crossover study. Drugs in R&d 14(2): 105-112, 2015

Bioequivalence studies for 2 different strengths of irbesartan/hydrochlorothiazide combination in healthy volunteers: 300/25 mg and 300/12.5 mg film-coated tablets. Drug Research 64(5): 257-262, 2014

Bioequivalence and pharmacokinetics of two 10-mg bisoprolol formulations as film-coated tablets in healthy white volunteers: a randomized, crossover, open-label, 2-period, single-dose, fasting study. International Journal of Clinical Pharmacology and Therapeutics 50(12): 909-919, 2013

Saquinavir 500 mg film-coated tablets demonstrate bioequivalence to saquinavir 200 mg hard capsules when boosted with twice-daily ritonavir in healthy volunteers. Antiviral Therapy 10(7): 803-810, 2005

Comparative pharmacokinetics and bioequivalence of two imatinib formulations as film-coated tablets, 400 mg. Pharmaceutical Chemistry Journal 46(10): 622-625, 2013