Yun Kuang, Sai-Ying Wang, Meng-Na Wang, Guo-Ping Yang, Can Guo, Shuang Yang, Xing-Fei Zhang, Xiao-Yan Yang, Qi Pei, Chan Zou, Yan-Hong He, Ying-Yong Zhou, Kai-Ming Duan, Jie Huang
Background: The present study evaluated the safety, pharmacokinetics/pharmacodynamics (PK/PD), and absolute bioavailability (Fabs) of Dex nasal spray in healthy adult subjects, which serves as a bridge for the subsequent study in children. Methods: Part 1: a double-blind, placebo-controlled, single ascending dose study was performed on 48 subjects. For 20-/40-μg groups, every 6/2 subjects received either Dex/placebo nasal spray or Dex/placebo injection in two periods. In total, 12/4 subjects each received 100 μg Dex/placebo nasal spray...
2022: Frontiers in Pharmacology