An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.

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Detailed Description

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Conditions

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Healthy Subjects Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Crossover

All subjects received all three treatments in a randomised order

Group Type EXPERIMENTAL

GSK1755165; placebo; zopiclone

Intervention Type DRUG

Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

Interventions

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GSK1755165; placebo; zopiclone

Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects providing written informed consent.

Exclusion Criteria

* Significant medical disorders;
* Sleeping difficulties; alcohol and/or substance abuse;
* Recent use of psychotropic medications, or need to use them during study;
* Very high BMI or very low BMI or bodyweight;
* Known hypersensitivity to the study medications or their excipients;
* Unwilling or unable to meet certain lifestyle or dietary restrictions during the study.

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes