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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00283790 |
Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator
Condition | Intervention | Phase |
---|---|---|
Insomnia |
Drug: zolpidem tartrate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Investigation of Psycliomotor and Cognitive Residual Effects After Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopielone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Plurazepam 30 mg As An External Comparator |
Estimated Enrollment: | 36 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2006 |
This is a crossover study, with 4 different treatments (Ambien, Lunesta, placebo, and flurazepam). The flurazepam arm always comes last due to the long washout period associated with it. The other 3 arms are randomized.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Study ID Numbers: | PM_L_0289 |
Study First Received: | January 27, 2006 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00283790 |
Health Authority: | United States: Food and Drug Administration |
Zolpidem Healthy |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses GABA Agonists Hypnotics and Sedatives |
Physiological Effects of Drugs Central Nervous System Depressants GABA Agents Central Nervous System Agents Pharmacologic Actions |