Trial Profile
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.
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 11 Sep 2015
Price :
$35
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At a glance
- Drugs Zolpidem (Primary) ; Zopiclone
- Indications Insomnia
- Focus Adverse reactions; Registrational
- 15 Jul 2011 The US FDA has stated that it cannot confirm the safety of Zolpidem based on the resubmitted NDA, which included data from this trial.
- 20 Oct 2010 Status changed from recruiting to completed.
- 19 Oct 2010 Preliminary results presented in a Transcept Pharmaceuticals media release.