Pharmacokinetics, pharmacodynamics and bioavailability of dexmedetomidine nasal spray in healthy Chinese adults: A phase I clinical trial.

ABSTRACT:

Background

Intranasal administration is a convenient route for drug delivery that can be applied for procedural sedation. However, there is currently limited exploration into fixed dosing regimens. This study was to investigate the pharmacokinetics (PK), pharmacodynamics (PD), bioavailability (BA) and safety of dexmedetomidine after fixed doses of intranasal and intravenous administration in healthy male and female subjects.

Methods

Group A subjects received intranasal or intravenous administration in two periods (12 subjects received intranasal dexmedetomidine (Dex) or the intravenous formulation, and four received the corresponding placebo). Groups B to F underwent single-period dose ascending, receiving only the intranasal Dex formulation or the corresponding placebo (the

SUBMITTER: Li Y 

PROVIDER: S-EPMC11638745 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature