Abstract
The primary objective of the study was to determine the bioavailability of 2 new formulations of azelastine (AZE) hydrochloride (0.10% and 0.15% AZE) containing sorbitol and sucralose compared with the commercially available 0.10% AZE. This study was performed in healthy volunteers based on the pharmacokinetic parameters maximum plasma concentration and area under the plasma concentration–time curve from time zero to the last measurable concentration. This was a Phase 1, open-label, single-center, randomized, parallel-group study.
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| Mean azelastine plasma concentration with time. |









