A Pharmacokinetic and Pharmacodynamic Study of Oral Dexmedetomidine.

ABSTRACT:

Background

Dexmedetomidine is only approved for use in humans as an intravenous medication. An oral formulation may broaden the use and benefits of dexmedetomidine to numerous care settings. The authors hypothesized that oral dexmedetomidine (300 mcg to 700 mcg) would result in plasma concentrations consistent with sedation while maintaining hemodynamic stability.

Methods

The authors performed a single-site, open-label, phase I dose-escalation study of a solid oral dosage formulation of dexmedetomidine in healthy volunteers (n = 5, 300 mcg; followed by n = 5, 500 mcg; followed by n = 5, 700 mcg). The primary study outcome was hemodynamic stability defined as lack of hypertension, hypotension, or bradycardia. The authors assessed this outcome by analyzing raw hemodynamic data

SUBMITTER: Chamadia S 

PROVIDER: S-EPMC7657968 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature