Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and  Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation

ConclusionsThe RS-DAT met BE criteria (range 80% –125%) versus SAC based on 90% CI of GMR for Cmax,ss and AUC0 –24h,ss. The LS-DAT was considered BE to SAC on the basis of the niraparib component meeting the BE criteria in the primary analysis for AUC0 –72h; abiraterone meeting the BE criteria in additional paired analyses based on Cmax,ss and AUC0 –24h,ss; and the percentage of simulated LS-DAT versus SAC BE trials meeting the BE criteria for both.ClinicalTrials.gov IdentifierNCT04577833.Graphical Abstract
Source: Clinical Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research