Assessment of the bioequivalence of two DPIs containing fluticasone and salmeterol, in patients with controlled or partly controlled asthma
| Autor: | Luigi Silvestro, Simona Rizea Savu, Katerina Athanassiou |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Inhalation business.industry Area under the curve 02 engineering and technology Pharmacology Bioequivalence 021001 nanoscience & nanotechnology medicine.disease 03 medical and health sciences 030104 developmental biology Oral administration Anesthesia Concomitant medicine Salmeterol 0210 nano-technology business medicine.drug Fluticasone Asthma |
| Zdroj: | 1.11 Clinical Problems - Asthma. |
| DOI: | 10.1183/13993003.congress-2016.pa618 |
| Popis: | Objectives: The aim of the study was to assess the bioequivalence of two DPIs containing fluticasone and salmeterol, being delivered via Rolenium®Elpen haler ® and Seretide®Diskus®, 100+50 mcg/inhalation, administered as single dose (each single dose consisting of two actuations). Methods : The study had an open label, four periods, fully replicate, crossover, controlled, block randomized, single dose design, in 60 patients with controlled or partly controlled asthma under fasting conditions. Equivalence was assessed after inhalation of each treatment (each single dose consisting of two actuations), with concomitant oral administration of activated charcoal (pre and post inhalation) to prevent GI absorption of the drugs. Primary PK parameters are the area under the curve (AUC 0-t ) and the maximum drug concentration in plasma (C max ). Equivalence was concluded since the 90%CI for the T/R ratio of AUC 0-t and C max , is within the limits 0.80 to 1.25 as shown in the Table below Conclusions: The current study proved that the fluticasone/salmeterol DPI administered via Elpenhaler inhalation device is bioequivalent to the reference product (fluticasone salmeterol administred via the Diskus device). Both treatments were well tolerated by the subjects. |
| Databáze: | OpenAIRE |
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