Journal de bioéquivalence et de biodisponibilité

Abstrait

An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Cross Over, Bioequivalence Study of Bosutinib 100 Mg Tablets of Abbott Laboratories Versus Bosulif (Bosutinib) 100 Mg Film Coated Tablets of Pfizer Limited Under Fed Condition in Healthy Subjects

Srinivas Gopineedu, Arjun Arumugam O, Geetha Lakshmi G, Nageswara Rao T, Sudipta Basu, Perez-Perez M, Hurtado- Colorado Karen, Gavino-Gutierrez AM, Claudia Lara, Higuera MJ, Peñaloza I

Bosutinib is protein kinase inhibitors that inhibit the abnormal BCR-ABL kinase that promotes CML the treatment of Newly-diagnosed Chronic Phase (CP) Philadelphia Chromosome-Positive Chronic Myelogenous Leukaemia (Ph+ CML). The purpose of this study was to evaluate the bioequivalence between Bosutinib 100 mg tablets of Abbott Laboratories versus Bosulif (Bosutinib) 100 mg film coated tablets of Pfizer Limited in healthy subjects. An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, cross over study with washout period of 07 days under fed condition was carried out in 58 male subjects in the age group of 19 to 44 years who met the study eligibility criteria, participated in the study and 46 subjects completed both periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analyzed to determine the plasma concentration of Bosutinib using bio-analytical method.

The 90% confidence interval of AUC_0-t and C_max were 93.65%-101.88% and 86.48%-103.69% respectively which were within the pre-defined acceptable limits and the test product is bioequivalent to the reference product.