Status:
COMPLETED
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Lead Sponsor:
Sanofi
Conditions:
Insomnia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
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, Usi...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy male and female subjects aged between 18 and 45 years.
- Usual bedtime between 21:00 and 01:00
- Body mass index (BMI) between 18 and 32 kg/m2.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and a complete physical examination).
- Laboratory tests within the normal range of the laboratory (hematology, biochemistry, urinalysis) or within the acceptable range per agreement between investigator and sponsor.
- Negative urine pregnancy test for females (to be confirmed at screening and prior to every dose of study medication)
- Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or they must be surgically sterilized or post-menopausal. If abstinent, women must agree to use double-barrier contraception throughout the study period should they become sexually active.
- Written informed consent signed
- EXCLUSION CRITERIA:
- Presence or history of clinically relevant cardiovascular, hepatic, pulmonary, gastrointestinal, renal, metabolic, hematological, neurologic or psychiatric disease, any acute infectious disease or signs of acute illness, and myasthenia gravis
- Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Symptomatic hypotension, whatever the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
- History of hypersensitivity to zolpidem, eszopiclone, or flurazepam.
- Use of any medication within one month prior to study start, except occasional use of acetaminophen or ibuprofen.
- History of drug abuse during prior twelve months
- Excessive consumption of xanthine-based beverages (more than 6 cups or glasses per day) or unable to stop consumption during the overnight study periods.
- Inability to communicate or cooperate with the investigator because of a language problem, poor mental status, or impaired cerebral status.
- Positive results of urine drug screen testing (amphetamines, benzodiazepines, cannabis, barbiturates, cocaine, opiates, antidepressants).
- Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins)
- Current use of tobacco products including cigarettes, cigars, pipes, or chewing tobacco, current participation in a smoking cessation program, or discontinuation of smoking within 3 months prior to screening
- Subject is currently participating in another clinical trial with an investigation product/device (or within 30 days of screening).
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00283790
Start Date
January 1 2006
End Date
April 1 2006
Last Update
April 3 2008
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807