PT  - JOURNAL ARTICLE
AU  - Colin Reisner
AU  - Carlos Fernandez
AU  - Patrick Darken
AU  - Paolo DePetrillo
AU  - Earl St. Rose
AU  - Tracy Fischer
AU  - Shannon Strom
AU  - Michael Kong
AU  - Kar Wong
AU  - Shahid Siddiqui
AU  - Greg Tardie
AU  - Chadwick Orevillo
TI  - Pearl's PT010 triple combination provides comparable budesonide exposure to symbicort and comparable glycopyrronium and formoterol exposure to PT003
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - 1891
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/1891.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/1891.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - 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.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.