Publication: Clinical Pharmacology in Drug Development
Abstract
This crossover study evaluated the bioequivalence of a single-tablet regimen (ACC008, combining ainuovirine, lamivudine, and tenofovir disoproxil fumarate) against co-administration of the individual component tablets in healthy Chinese adults. Plasma drug concentrations were measured by LC-MS/MS and pharmacokinetic parameters calculated using Phoenix WinNonlin. All 90% confidence intervals for Cmax and AUC measures fell within the standard bioequivalence range, and safety was comparable between the single-tablet and separate-tablet regimens with no serious adverse events. The results confirm that the single-tablet regimen is bioequivalent to separate administration of its components with a favorable safety profile, supporting its potential to simplify antiretroviral therapy.
Author(s): Huang L, Lei J, Yang Y, Ma T, Lin H, Cao B, Li J
Published: 2023 年 7 月 20 日
Phoenix WinNonlin: Simplifying a Three-Drug Regimen
Phoenix WinNonlin's pharmacokinetic analysis confirmed bioequivalence between a single combination tablet and its three separate components in this antiretroviral study. Within a Phoenix platform built on more than 30 years of PK/PD expertise, Phoenix WinNonlin's output can become submission-ready tables, figures, and listings through TFL Studio.
