drugset / Trial / NCT02155309

Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

NCT02155309

Phase 2/3 Terminated 63 enrolled Repurposed Therapeutics, Inc.
RandomizedCrossoverQuadruple-blindTreatment

Summary

Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.

Timeline

Start
2014-06
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Scopolamine Unknown 0.2 mg Intranasal

Indications