Teva frazer pa3/14/2024 ![]() Equivalence was observed without use of charcoal (overall absorption post-inhalation) and with charcoal (pulmonary absorption). Bioequivalence of BF Spiromax with BF Turbohaler was demonstrated for budesonide and formoterol (AUC 0–t and C max (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)). Results: In each study, 90 healthy volunteers were randomized. PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose. All treatments were administered with and without charcoal. 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. Materials and methods: Two single-center, open-label, randomized, 5-period crossover studies were performed. We performed two studies to demonstrate pharmacokinetic (PK) equivalence of BF Spiromax with BF Turbohaler. Abstract Objective: Budesonide formoterol (BF) Spiromax ® is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort ® Turbohaler ®.
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