drugset / Trial / NCT00878553

Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

NCT00878553

RandomizedCrossoverTriple-blindTreatment

Summary

SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

Timeline

Start
2010-05
Primary completion
2010-12
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Zaleplon Small molecule 10 mg Oral
Subject Zaleplon Small molecule 15 mg Oral
Subject Zaleplon Small molecule 20 mg Oral

Indications