Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 µg Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler

Conclusions SFC 50/100 µg Rotacaps®/Rotahaler® showed comparable fluticasone propionate and salmeterol systemic exposure to Diskus® for all pharmacokinetic endpoints with GMR and both upper and lower limits of 90 % CIs within conventional acceptance criteria for bioequivalence (0.8, 1.25), sufficient for considering progression of the Rotacaps®/Rotahaler® product for further clinical development.

http://link.springer.com/10.1007/s40261-015-0282-x

Source: Clinical Drug Investigation - March 25, 2015 Category: Drugs & Pharmacology Source Type: research