Bioequivalence of budesonide plus formoterol (BF) Spiromax® and BF Turbohaler® (with and without charcoal block) in healthy volunteers.
2015
Abstract
Budesonide formoterol(BF) Spiromax® is a breath-actuated
dry-powder inhalerdesigned to deliver similar combinations of
budesonideand
formoterolas Symbicort® Turbohaler®. We performed two studies to demonstrate pharmacokinetic (PK) equivalence of BF Spiromax with BF Turbohaler. Two single-center, open-label, randomized, 5-period crossover studies were performed. The first study compared BF Spiromax 160/4.5 μg with BF Turbohaler 200/6 μg, while the second study compared BF Spiromax 320/9 μg with BF Turbohaler 400/12 μg. All treatments were administered with and without
charcoal. PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose. In each study, 90 healthy volunteers were randomized.
Bioequivalenceof BF Spiromax with BF Turbohaler was demonstrated for
budesonideand
formoterol(AUC0-t and Cmax (90% confidence intervals of the geometric mean between-device ratios for both parameters were within the predefined range of 0.80-1.25 in both studies)). Equivalence was observed without use of
charcoal(overall absorption post-inhalation) and with
charcoal(pulmonary absorption). There were no major differences between treatments in tmax for either
budesonideor
formoterol. All study treatments were well tolerated (one treatment-emergent adverse event (TEAE) in the medium-dose study and four TEAEs in the high-dose study). These studies indicate that BF Spiromax (±
charcoalblock) is
bioequivalentto BF Turbohaler with respect to the PK parameters assessed. Single doses of BF Spiromax were well tolerated; the overall safety profile of BF Spiromax and BF Turbohaler was similar.
Keywords:
-
Correction
-
Source
-
Cite
-
Save
0
References
9
Citations
NaN
KQI