Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8537694 | Pulmonary Pharmacology & Therapeutics | 2018 | 31 Pages |
Abstract
Both doses of BGF MDI were well tolerated in healthy subjects of Japanese descent and the systemic exposure to budesonide was dose proportional for BGF MDI 160/14.4/10â¯Î¼g and BGF MDI 320/14.4/10â¯Î¼g. The safety and pharmacokinetics for BGF MDI 160/14.4/10â¯Î¼g and BGF MDI 320/14.4/10â¯Î¼g in Japanese subjects were comparable to data from previous studies in Western populations, which suggests that the safety and efficacy profile of BGF MDI should be similar in Western and Japanese subjects.
Keywords
Cmaxn.a.NCANon-Compartmental AnalysisSAEMDIAUC0–12AUC0–∞tmaxICSt½apparent terminal elimination half-lifeLLQGFFBGFRACCL/FLAMATEAElong-acting muscarinic antagonistLong-acting β2-agonistelectrocardiogramECGstandard deviationCOPDChronic obstructive pulmonary diseaseRandomizationlower limit of quantificationmaximum observed plasma concentrationNot availableMetered Dose InhalerCV%LABAbody mass indexBMICoefficient of Variationadverse eventSerious adverse eventtreatment-emergent adverse eventWesternCo-suspension delivery technologyJapaneseInhaled corticosteroid
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Authors
Paul Dorinsky, Paolo DePetrillo, Shahid Siddiqui, Andrea Maes, Colin Reisner,