Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies.
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| Title: | Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies. |
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| Authors: | Bednarczyk A; Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca Pharma Poland, Warsaw, Poland., Aurivillius M; Respiratory and Immunology, Global Patient Safety, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Jassal M; Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Shah M; Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Raphiou I; Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Durham, NC, USA., Petullo D; Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Xu J; Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Heijer M; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Sychowicz K; Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca Pharma Poland, Warsaw, Poland., Collison K; Respiratory and Immunology, Clinical Operations, Biopharmaceuticals R&D, AstraZeneca, Durham, NC, USA., Silva C; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK., Reddy J; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK., Han D; Parexel, Glendale, CA, USA., Goldwater R; Parexel, Baltimore, MD, USA., Gillen M; Creek Lane PK, LLC, Waterford, VA, USA., Patel M; Respiratory & Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Academy House, 136 Hills Road, Cambridge CB2 8PA, UK. |
| Source: | Therapeutic advances in respiratory disease [Ther Adv Respir Dis] 2026 Jan-Dec; Vol. 20, pp. 17534666261417149. Date of Electronic Publication: 2026 Feb 12. |
| Publication Type: | Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I; Comparative Study |
| Journal Info: | Publisher: SAGE Publications Country of Publication: England NLM ID: 101316317 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1753-4666 (Electronic) Linking ISSN: 17534658 NLM ISO Abbreviation: Ther Adv Respir Dis Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1753-4666 |
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| DOI: | 10.1177/17534666261417149 |
