Zeitschrift für Bioäquivalenz und Bioverfügbarkeit

Abstrakt

An Open Label, Balanced, Randomized, Two Treatments, Three Sequences, Three Periods, Single Dose, Semi-Replicate, Crossover, Oral Bioequivalence Study of Palbociclib 125 Mg Capsules of Abbott Laboratories De Colombia Versus Ibrance (Palbociclib) 125 Mg Capsules of Pfizer in Healthy, Adult, Human Subjects Under Fed Conditions

Arjun Arumugam O, Geetha Lakshmi G, Srinivas Gopineedu, Nageshwara Rao T, Hurtado-Colorado Karen, Perez-Perez Marcela, Higuera Maria Juliana , Gavino-Gutierrez Arquímedes M, Claudia Lara

Palbociclib is a kinase inhibitor that inhibits Cyclin-Dependent Kinases (CDK) 4 and 6 that is indicated for the treatment of Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The purpose of this study was to evaluate the bioequivalence between Palbociclib 125 mg Capsules of Abbott Laboratories de Colombia vs. Ibrance (Palbociclib) 125 mg Capsules of Pfizer in healthy subjects. An open label, balanced, randomized, two treatments, three sequences, three periods, single dose, semi replicate, cross over with washout period of 10 days under fed condition was carried out in 48 male subjects in the age group of 23 to 45 years who met the study eligibility criteria, participated in the study and 44 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 Palbociclib using bio-analytical method. The ISCV of reference product for Cmax is 11.21% and the 90% confidence interval of the relative mean Cmax of the test to reference drug product for Ln-transformed data is within 80.00%-125.00% 90% confidence interval of the relative mean AUC0-72 of the test to reference drug product for Ln-transformed data were within 80.00%-125.00%, thus establishing bioequivalence.