Equivalent Systemic Exposure to Fluticasone Propionate/Salmeterol Following Single Inhaled Doses from Advair Diskus and Wixela Inhub: Results of Three Pharmacokinetic Bioequivalence Studies.

Journal of Aerosol Medicine and Pulmonary Drug Delivery
Scott HaughieJon Ward

Abstract

Background: Wixela® Inhub® was developed to deliver inhaled fluticasone propionate/salmeterol (FP/S) combination as a substitutable generic equivalent to Advair® Diskus®. These studies aimed to confirm the pharmacokinetic bioequivalence (BE) of FP/S after single doses of Wixela Inhub (test [T]) and Advair Diskus (reference [R]). Methods: Three open-label, randomized, two-way crossover, single-dose studies in healthy subjects (N = 66 each) compared the systemic exposure of FP and salmeterol after inhalation from three dose strengths of FP/S (100/50, 250/50, or 500/50 μg) delivered from T and R. Primary BE endpoints were the area under the plasma concentration-time curve from time = 0 to the last measurable concentration (AUC(0-t)) and the maximum observed plasma concentration (Cmax) for both FP and S. The BE acceptance criteria specified that the 90% confidence intervals (CIs) of the geometric mean T/R ratios for AUC(0-t) and Cmax can be contained within 0.80-1.25 for both FP and salmeterol. Results: Wixela Inhub met the acceptance criteria for BE for FP and salmeterol at each dose strength. Estimated AUC(0-t) and Cmax geometric mean ratios (T/R [90% CI]) for FP were, respectively, 1.04 (1.00-1.08) and 0.92 (0.87-0.96) for 100/5...Continue Reading

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Citations

Mar 14, 2020·Expert Review of Respiratory Medicine·Luigino CalzettaPaola Rogliani
Oct 22, 2019·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Dik NgRichard Allan
May 21, 2020·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Andrew CooperRichard Allan
Jun 20, 2020·Therapeutic Innovation & Regulatory Science·Swapnil Dylan Fernandes, Marina Koland
Dec 8, 2020·Pulmonary Therapy·James F DonohueAndrew Cooper
Nov 3, 2021·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Thomas ShepherdAdrian Parkinson

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Clinical Trials Mentioned

NCT02245672

Software Mentioned

Phoenix
WinNonlin
Wixela Inhub
SAS

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