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)
NCT ID: NCT00798395
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2007-10-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment 1
Org 50081
1.5 mg on day 1-7
Treatment 2
Org 50081
4.5 mg on Day 1-7
Treatment 3
Placebo
Once daily on Day 1-7
Treatment 4
zopiclone
Single dose of 7.5 mg
Interventions
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Org 50081
1.5 mg on day 1-7
Org 50081
4.5 mg on Day 1-7
Placebo
Once daily on Day 1-7
zopiclone
Single dose of 7.5 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* Medication or drug use of any kind prior to the study
* Relevant history or presence of a significant medical illness
21 Years
45 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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21105
Identifier Type: -
Identifier Source: secondary_id
P05794
Identifier Type: -
Identifier Source: org_study_id
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