Journal of Bioequivalence & Bioavailability

Dalia Jawhari

Publications

• Research Article
  Bioavailability of a New Generic Formulation of Imatinib Mesylate 400mg Tablets Versus Glivec in Healthy Male Adult Volunteers
  Author(s): Dalia Jawhari, Mahmoud Al Swisi and Mahmoud GhannamDalia Jawhari, Mahmoud Al Swisi and Mahmoud Ghannam
  
  Imatinib is a highly selective inhibitor of tyrosine kinase used in the treatment of CML and GIST. However, the cost of the drug is prohibitive especially in the developing countries. The aim of this study is to compare pharmacokinetics profile of a new Imatinib generic formulation (Imatinib tablets 400mg batch number: 2090602, Hikma Pharmaceuticals PLC) with those of Glivec, (batch number: S0143, Novartis Pharma AG, Basle, Switzerland) in healthy male volunteers /fed state. The study was single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design. The study was performed by CRO Algorithme Pharma Inc, (Quebec, Canada) in accordance with Good Clinical Practices and the applicable regulatory requirements. Male volunteers, non- or ex-smokers, of at least 18 years of age but not older than 55 years with a body mass index (BMI) greater than or equal t.. View More»
  DOI: 10.4172/jbb.1000077

  Abstract PDF