NCT00798395

A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.

Conditions

• Sleep Initiation and Maintenance Disorders
• Mental Disorders

Interventions

Type	Name	Description
DRUG	Org 50081	1.5 mg on day 1-7
DRUG	Org 50081	4.5 mg on Day 1-7
DRUG	Placebo	Once daily on Day 1-7
DRUG	zopiclone	Single dose of 7.5 mg

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-11-26
• Last updated: 2015-10-14