Assessment of next-morning driving performance after middle of the night administration of zolpidem tartrate sublingual tablet 3.5 mg in healthy adult volunteers: single-center, double-blind, randomized, placebo-controlled, four-way crossover study
Completed
- Conditions
- onderzoek betreft gezonde vrijwilligersinsomniasleeplessness10040998
- Registration Number
- NL-OMON34606
- Lead Sponsor
- Transcept Farmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Healthy
Age 21 till 64
Possession of valid driving licence
Sufficient driving experience (at least 3000 km/year over the past three years)
Exclusion Criteria
Use of medication that may influence driving performance
Excessive use of alcohol, nicotine or cafeine
Use of drugs
For women: pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Impaired Drivers, where Impaired Driver is a binary indicator defined for<br /><br>subject i to be 1 if TreatmentSDLP[i] - PlaceboSDLP[i] > 2.5 cm and zero<br /><br>otherwise.<br /><br>The abbreviation SDLP is Standard Deviation of Lateral Position (in cm). This<br /><br>is an index of weaving of the car on the road.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Impaired Drivers, where Impaired Driver is a binary indicator defined for<br /><br>subject i to be 1 if:<br /><br>a.TreatmentSDLP[i] - PlaceboSDLP[i] > 3.5 cm and zero otherwise,<br /><br>b. TreatmentSDLP[i] - PlaceboSDLP[i] > 2 cm and zer otherwise.<br /><br><br /><br>- SDLP in centimeters<br /><br>- Standard Deviation of Speed (SDS) in km/h</p><br>