Abstract
This is a pharmacokinetic study of two formulations containing Irbesartan 300 mg. Its objective was to compare the Bioavailability between the Test product (Irbesartan produced by Tecnoquimicas S.A., Colombia laboratory) and the Reference product (Aprovel® produced by Sanofi Aventis laboratory) in order to be able to state the Bioequivalence between them. For this, an open label, two periods, two randomized sequences, crossover, single fasting 300 mg dose study was performed with an 8-day washout period between each period in 24 healthy volunteers and collection of 12 plasma samples between 0 and 48 hours. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 83.0 – 113.9 with a 97.2 ratio; for the AUC0-t parameter the 90% CI it is between 92.1 -116.7 with a 103.7 ratio, and for the AUC0-∞ the 90% CI was found to be between 95.5 – 114.8 with a 104.7 ratio. According to the European and FDA guidelines, the confidence interval falls within the permissible ranges for Bioequivalence and Interchangeability declaration of the Tecnoquimicas S.A. product with the Sanofi Aventis Reference product, Aprovel®
Highlights
Bosutinib can be categorized under subclass of drugs, known as kinase inhibitors
Adult patients suffering from chronic myeloid leukemia with Philadelphia chromosome positive (Ph+CML) in Chronic Phase (CP), Accelerated Phase (AP) or Blastic Phase (FB) are advised to be treated with Bosutinib, previously treated with one or more inhibitors tyrosine kinase and for whom treatment with imatinib, nilotinib and dasatinib are not considered appropriate [2]
This study aims at establishing the bioequivalence of the constituents having Irbesartan 500 mg tablets by relating the bioavailability, after one dosage, of the test product by Lafrancol S.A. (Colombia) and the Reference product, Bosulif®, produced by Pfiezer
Summary
Bosutinib can be categorized under subclass of drugs, known as kinase inhibitors. The abnormal kinase Bcr-Abl is inhibited Bosutinib. The study models explained the conjugation of bosutinib and the kinase domain of Bcr-Abl. The Src kinase family, including Src, Lyn and Hck can be inhibited by Bosutinib, and PDGF receptor and c-Kit are minimally inhibited [1]. Adult patients suffering from chronic myeloid leukemia with Philadelphia chromosome positive (Ph+CML) in Chronic Phase (CP), Accelerated Phase (AP) or Blastic Phase (FB) are advised to be treated with Bosutinib, previously treated with one or more inhibitors tyrosine kinase and for whom treatment with imatinib, nilotinib and dasatinib are not considered appropriate [2]. A physician should be experienced in the diagnosis and treatment of CML, to treat such patients (Tables 1 and 2)
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