| Popis: |
Objectives: The aim of the studies was to assess the bioequivalence of two DPIs containing budesonide and formoterol, being delivered via Elpenhaler® and Turbuhaler®, respectively. Two PK studies were conducted. Methods: The first study had an open, randomized, two-sequence, two-period, crossover, single dose design in 100 asthmatic patients under fasting conditions. Equivalence was assessed after single inhalation of each treatment with concomitant oral administration of activated charcoal to prevent GI absorption of the drugs. The second study had a two-stages, two sequences, four period, crossover, randomized, controlled, fully replicate design in 48 healthy volunteers. Primary PK parameters estimated, the area under the curve (AUC0-t) and the maximum drug concentration in plasma (Cmax). Equivalence was concluded since the 90% CI for the T/R ratio of AUC0-t and Cmax, is within the limits 0.80 to 1.25 as shown in the Tables below View this table: Table 1 Bioequivalence comparison after the administration of activated charcoal View this table: Table 2 Bioequivalence comparison without the administration of activated charcoal Conclusions: Both studies showed the formulations are bioequivalent regarding both to rate and extent of absorption. Both treatments were well tolerated by the subjects. |
