Status:
COMPLETED
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
25-40 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00699608
Start Date
July 1 2008
End Date
October 1 2008
Last Update
June 5 2012
Active Locations (1)
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1
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XP