Open-Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently
| Autor: | David Ramsay, Graeme Young, Adeep Puri, Teresa Fuller, Alex Georgiou, Claire Ambery, Peter T. Daley-Yates |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.drug_class bronchodilator Pharmaceutical Science Original Manuscript Pharmacology Quinolones 030226 pharmacology & pharmacy Fluticasone propionate Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Pharmacokinetics Bronchodilator Medicine Humans Pharmacology (medical) batefenterol Cross-Over Studies business.industry Inhaler Muscarinic antagonist fluticasone furoate Articles Middle Aged Crossover study Healthy Volunteers Androstadienes Drug Combinations bifunctional molecule chemistry 030220 oncology & carcinogenesis Area Under Curve triple therapy Corticosteroid Drug Therapy Combination Female Vilanterol Carbamates business medicine.drug |
| Zdroj: | Clinical Pharmacology in Drug Development |
| ISSN: | 2160-7648 |
| Popis: | The study aim was to investigate the pharmacokinetics of single high doses and repeated therapeutic doses of fluticasone furoate (FF) and batefenterol (BAT; a bifunctional muscarinic antagonist and β2‐agonist) administered in combination (BAT/FF) or as monotherapy. In this open‐label, 6‐period, crossover study of 48 subjects, the treatment sequences were (1) single high‐dose BAT/FF 900/300 μg followed by repeated therapeutic doses of BAT/FF 300/100 μg (once daily for 7 days); (2) single high‐dose BAT 900 μg administered concurrently with FF 300 μg; (3) single high‐dose BAT 900 μg followed by repeated therapeutic‐dose BAT 300 μg; (4) single high‐dose FF 300 μg followed by repeated therapeutic‐dose FF 100 μg; (5) single high‐dose FF 300 μg (magnesium stearate); and (6) single high‐dose FF/vilanterol 300/75 μg. Plasma FF area under the plasma drug concentration‐time curve (AUC) was reduced after single high‐dose BAT/FF versus FF alone (ratio of geometric least squares means: 0.79; 90% confidence interval: 0.75‐0.83). After repeat dosing, FF AUC at the lower therapeutic dosage was similar for BAT/FF and FF (primary endpoint; AUC geometric least squares means: 1.03). Adverse events were minor, the most common being cough. These data support the feasibility of developing BAT/inhaled corticosteroid triple therapy in a single inhaler. |
| Databáze: | OpenAIRE |
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