The Pharmacokinetics and Efficacy of a Low-dose, Aqueous, Intranasal Scopolamine Spray
Abstract
The study examined both the pharmacokinetic properties and efficacy of a low-dose, aqueous, intranasal scopolamine spray (INSCOP) as an anti-motion sickness prophylaxis. The study was divided into two phases: a pharmacokinetics (PK) phase, which established pharmacokinetic parameters, and an Efficacy phase, which was a within-subjects, cross-over, double blind, placebo controlled trial testing the efficacy of INSCOP during mechanical rotation. Cognitive testing, blood samples, subjective alertness, and adverse events were collected in both parts. INSCOP is rapidly absorbed, having detectable plasma levels in 10 to 15 minutes for most subjects, and reaching maximum plasma concentrations typically within 60 minutes. Measured by the number of head tilts tolerated during mechanical rotation, subjects receiving INSCOP tolerate an average of 31 head tilts more when using INSCOP compared to a placebo condition. Cognitive assessments and subjective fatigue measurements were not significantly different between conditions. INSCOPs positive efficacy and safety profile having been identified, future studies can address multi-dose schedules and operational field trials.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 27, 2017
- Accession Number
- AD1039811
Entities
People
- Daniel J. Geyer
- Eric M. Littman
- Jacqueline Gomez
- Matthew R Doubrava
- William J Becker
Organizations
- Naval Medical Research Unit Dayton