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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00798395

Enrollment

Registered

2008-11-26

Start date

2007-10-31

Completion date

2008-09-30

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders, Sleep Initiation and Maintenance Disorders

Brief summary

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

Interventions

DRUGOrg 50081

1.5 mg on day 1-7

DRUGPlacebo

Once daily on Day 1-7

DRUGzopiclone

Single dose of 7.5 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject has at least 3 years of car driving experience * Subject signs the trial Informed Consent Form * Subject is in a healthy condition as judged by the investigator * Subject has a regular sleep pattern

Exclusion criteria

* Subject has insomnia or any other sleep disorder * Medication or drug use of any kind prior to the study * Relevant history or presence of a significant medical illness

Design outcomes

Primary

Measure	Time frame
The Standard Deviation of Lateral Position	Day 8

Secondary

Measure	Time frame
Psychomotor and cognitive performance tasks	Day 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026