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' 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® MDI 320/9µg 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.
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.
- © 2014 ERS