@article {Reisner1891, author = {Colin Reisner and Carlos Fernandez and Patrick Darken and Paolo DePetrillo and Earl St. Rose and Tracy Fischer and Shannon Strom and Michael Kong and Kar Wong and Shahid Siddiqui and Greg Tardie and Chadwick Orevillo}, title = {Pearl{\textquoteright}s PT010 triple combination provides comparable budesonide exposure to symbicort and comparable glycopyrronium and formoterol exposure to PT003}, volume = {44}, number = {Suppl 58}, elocation-id = {1891}, year = {2014}, publisher = {European Respiratory Society}, abstract = {Introduction: To our knowledge, no fixed-dose triple combination has been formulated without a drug-drug interaction (DDI). Budesonide (BD), glycopyrronium (GP), and formoterol fumarate (FF) MDI (BGF MDI, PT010) is a fixed-dose ICS/LAMA/LABA in Pearl Therapeutics{\textquoteright} co-suspension technology in development for COPD. The objectives of this study were to identify a dose of BD in BGF MDI that provides comparable PK to BD following administration of Symbicort{\textregistered} MDI 320/9{\textmu}g and assess whether a DDI exists, comparing PK of GFF MDI (PT003) to BGF MDI.Methods: This Phase I, randomized, double-blind within device, single-dose, crossover study randomized 84 healthy subjects to BGF MDI 320/14.4/9.6μg, GFF MDI 14.4/9.6μg and Symbicort MDI 320/9μg, and either: BGF MDI 160/14.4/9.6μg, BGF MDI 80/14.4/9.6μg or Symbicort MDI 160/9μg. PK parameters were derived from plasma concentration-time data.Results: Bioequivalence (BE) was achieved for all relevant comparisons.View this table:Similar observations were made for lower dose comparisons.Conclusion: No DDI was evident when comparing PK of BGF MDI to GFF MDI. Systemic exposure to BD following administration of BGF MDI 320/14.4/9.6μg was slightly higher but BE to Symbicort MDI 320/9μg.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/44/Suppl_58/1891}, eprint = {https://erj.ersjournals.com/content}, journal = {European Respiratory Journal} }