Open AccessPharmacokinetic study for the establishment of bioequivalence of two inhalation treatments containing budesonide plus formoterol
Author(s) -
Grekas Nikolaos,
Athanassiou Katerina,
Papataxiarchou Katerina,
Rizea Savu Simona,
Silvestro Luigi
Publication year - 2014
Publication title -
journal of pharmacy and pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.745
H-Index - 118
eISSN - 2042-7158
pISSN - 0022-3573
DOI - 10.1111/jphp.12303
Subject(s) - bioequivalence , pharmacokinetics , budesonide , cmax , medicine , formoterol , confidence interval , crossover study , inhalation , pharmacology , bronchodilator , asthma , anesthesia , placebo , alternative medicine , pathology
Objectives The aim of this study was to compare lung deposition and assess the bioequivalence of two formulations containing budesonide and formoterol and being delivered via E lpenhaler and T urbuhaler, respectively. A pharmacokinetic ( PK ) study was conducted. Methods An open, randomized, two‐sequence, two‐period, crossover, single‐dose study in 100 asthmatic patients under fasting conditions was performed. Wash out period was 6 days. Equivalence in lung deposition was assessed after a single inhalation of each treatment with concomitant oral administration of activated charcoal (40 g) to prevent gastrointestinal absorption of the drugs. Several PK parameters were estimated, the area under the drug concentration in plasma versus time curve ( AUC 0−t ) and the maximum drug concentration in plasma ( C max ) being the primary response variables. Equivalent lung deposition was concluded if the 90% confidence interval ( CI ) for the E lpenhaler/ T urbuhaler geometric mean ratio of AUC 0−t and C max , for both drug substances fell within the regulatory limits (0.80–1.25). Key findings Acceptance criteria were met. Equivalent lung deposition can be concluded. No statistically significant differences between treatments in the incidence of adverse events were found. Conclusions The formulations are bioequivalent regarding both rate and extent of absorption. The treatments were also well tolerated by the participating subjects.