生物学的同等性とバイオアベイラビリティのジャーナル

概要

An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Four Periods, Fully Replicate, Crossover, Bioequivalence Study of Abiraterone Acetate 250 mg Tablets of Abbott Laboratories De Colombia Versus ZYTIGA® (Abiraterone Acetate) 250 mg Tablets of Janssen Biotech, Inc. Under Fasting Condition in Healthy Subjects

Srinivas Gopineedu, Arjun Arumugam O, Arquímedes M Gavino-Gutierrez, Hurtado-Colorado Karen, Claudia Lara, Higuera MJ, Peñaloza I

Abiraterone acetate is an androgen biosynthesis inhibitor, that inhibits 17 a-hydroxylase/C17,20-lyase (CYP17) the treatment of newly diagnosed high risk metastatic Hormone Sensitive Prostate Cancer (mHSPC) in adult men in combination with Androgen Deprivation Therapy (ADT). The purpose of this study was to evaluate the bioequivalence between Abiraterone acetate 250 mg tablet of Abbott laboratories de Colombia versus marketed Abiraterone acetate 250 mg tablet of Janssen Biotech, Inc. under fasting condition in healthy subjects. An open label, balanced, randomized, two treatments, two sequences, four periods, fully replicate, cross-over single dose study with washout period of 02 days under fasting condition was carried out in 48 male subjects in the age group of 21 to 45 years who met the study eligibility criteria, participated in the study and 47 subjects completed all four periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Abiraterone acetate using bio-analytical method.

The 90% confidence interval of AUC_0-t and C_max were 87.27%-104.58% and 79.10%-99.68% respectively which were within the pre-defined acceptable limits and the test product is bioequivalent to the reference product.